A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02358343
Collaborator
University of Texas (Other), University of New Mexico (Other), Patient-Centered Outcomes Research Institute (Other)
184
3
5
32.8
61.3
1.9
Study Details
Study Description
Brief Summary
Patients whose kidneys fail generally require dialysis treatments to sustain life. The ability of patients to make major adjustments in their lives for dialysis is hampered by depression that affects almost one-quarter of such individuals. There are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment, psychotherapy and anti-depressant drug therapy.
To fill this important gap in the investigators knowledge, the investigators propose to undertake (1) a randomized controlled clinical trial of 200 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from among individuals receiving care in 50 dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants. In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined.
The two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
BACKGROUND Patients with end-stage renal disease undergoing maintenance hemodialysis (HD) have to adjust to complex treatment regimens, and experience frequent care transitions. This is compounded by a four-fold higher prevalence of comorbid depression than in the general population, which is strongly associated with poor patient-centered outcomes. Yet, depression is often not diagnosed when present, not treated when identified, and many HD patients are reluctant to accept treatment. This is likely a result of lack of high-quality evidence for the efficacy of different treatment options for comorbid depression in HD patients. OBJECTIVES Conduct an open-label, randomized controlled clinical trial among HD patients with comorbid depression to (1) compare the efficacy of an engagement interview with usual care in increasing acceptability of treatment (n=200); and (2) compare the efficacy of 12 weeks of cognitive behavioral therapy (CBT) or anti-depressant drug therapy (sertraline) for reducing the severity of depressive symptoms, and other meaningful outcomes (n=120). METHODS HD patients in up to 50 dialysis facilities in three different regions (Albuquerque, NM; Dallas, TX; Seattle, WA) will be pre-screened for the presence of clinically significant depressive symptoms. Patients with a confirmed diagnosis of major depression or dysthymia will be randomly assigned to an engagement interview or usual care to determine efficacy in increasing acceptability of treatment (n=200). Individuals who agree to treatment will be randomly assigned to individual CBT or drug therapy. CBT will be administered in a dialysis facility by a trained therapist. Sertraline will be titrated to the maximum tolerated dose using Measurement Based Care, a model of shared-decision-making. Patient-reported outcomes will be measured by a single assessor for all three sites, blinded to the treatment assignment. The primary efficacy measure will be a change in severity of depressive symptoms; secondary outcome measures will assess other important patient-reported outcomes such as somatic symptom burden, functioning, and adherence with dialysis treatment, diet, and medications. The longitudinal evolution of symptoms in patients who refuse to accept any treatment either within or outside the clinical trial will also be studied (n=40). PATIENT OUTCOMES (PROJECTED) This study will provide answers to three questions faced by HD patients with clinically significant depressive symptoms: (1) "Given my preferences, what should I expect will happen to me?"; (2) "What are my options, and what are the potential benefits and harms of these options?"; and (3) "What can I do to improve the outcomes that are most important to me?" Oversight of study will be provided by separate Patient Council and Stakeholder Council to align with PCORI's mission of generating high-integrity, evidence-based information from research guided by patients, caregivers, and broader health care community.
Study Design
Study Type:
Interventional
Actual Enrollment
:
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ASCEND: A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression
Actual Study Start Date
:
Mar 23, 2015
Actual Primary Completion Date
:
Nov 15, 2017
Actual Study Completion Date
:
Dec 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Engagement Interview Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same. |
Behavioral: Engagement Interview
An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
|
| No Intervention: Control Visit Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial. |
|
| Active Comparator: Cognitive Behavioral Therapy The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT will be administered while the patient is undergoing HD; however, alternative arrangements will be made upon individual patient's preferences. |
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. During the course of intervention, study subjects will undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).
Other Names:
|
| Active Comparator: Antidepressant Drug Therapy The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
Drug: Antidepressant Drug Therapy
The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.
Other Names:
|
| No Intervention: Observational Cohort Subjects who (1) are not willing to participate in the clinical trial and (2) do not find any treatment acceptable outside the clinical trial will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C. |
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Initiated Depression Treatment [within four weeks of engagement interview or control visit]
The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition. This will be defined as one of the following: Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia. Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia.
- QIDS-C Score [Week 12 of treatment]
The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups.
Secondary Outcome Measures
- Number of Participants Who Accepted Depression Treatment [within two weeks of engagement interview or control visit]
The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment. This will be measured by the patient's intent and will be defined as one of the following: Signing the informed consent to be randomly assigned to individual CBT or drug therapy Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community. Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia.
- BDI-II [Week 12]
Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression
- GAD-7 [Week 12]
Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety
- Sheehan Disability Scale [Week 12]
range 0-30, higher scores indicate worse disability
- SF-36 Energy/Vitality [Week 12]
Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality
- Global Quality of Life Scale [Week 12]
range 0-10, higher scores indicate better quality of life
- Satisfaction With Life Scale [Week 12]
range 1-35, higher scores indicate better satisfaction
- Perceived Social Support [Week 12]
Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support
- PSQI [Week 12]
Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality
- Exercise [Week 12]
Single item activity measure, range 1-6, higher indicates less activity
- Percentage of Dialysis Treatment Sessions Skipped and/or Shortened [Over 12 Weeks]
Treatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment.
- Percent Inter-dialytic Weight Gain [Week 12]
Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study
- Serum Phosphorus Level [Week 12]
Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥ 21 years;
-
Undergoing thrice-weekly maintenance HD for ≥ 3 months;
-
Able to speak either English or Spanish;
-
BDI-II score ≥ 15; and
-
Meets diagnostic criteria for either current major depressive episode or dysthymia on the MINI.
Exclusion Criteria:
-
Active suicidal intent;
-
Ongoing psychotherapy or current treatment with certain anti-depressant drugs;
-
Evidence of cognitive impairment on Mini-Cog;
-
Present or past psychosis or bipolar disorder I or II on the MINI;
-
Alcohol or substance abuse diagnosed on the MINI or history of such abuse in the past three months;
-
Life expectancy < 3 months, in the judgment of the site principal investigator;
-
Anticipated to receive living related donor kidney transplantation within 3 months;
-
Pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control;
-
Clinical and/or laboratory evidence of chronic liver disease;
-
History of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding;
-
Current use of class I anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and St. John's wort; and
-
Known hypersensitivity to sertraline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of New Mexico | Albuquerque | New Mexico | United States | 87131 |
| 2 | University of Texas Southwestern | Dallas | Texas | United States | 75390 |
| 3 | University of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- University of Washington
- University of Texas
- University of New Mexico
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Rajnish Mehrotra, MD, University of Washington
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Atalay H, Solak Y, Biyik M, Biyik Z, Yeksan M, Uguz F, Guney I, Tonbul HZ, Turk S. Sertraline treatment is associated with an improvement in depression and health-related quality of life in chronic peritoneal dialysis patients. Int Urol Nephrol. 2010 Jun;42(2):527-36. doi: 10.1007/s11255-009-9686-y. Epub 2009 Dec 2.
- Cukor D, Coplan J, Brown C, Peterson RA, Kimmel PL. Course of depression and anxiety diagnosis in patients treated with hemodialysis: a 16-month follow-up. Clin J Am Soc Nephrol. 2008 Nov;3(6):1752-8. doi: 10.2215/CJN.01120308. Epub 2008 Aug 6.
- Cukor D, Rosenthal DS, Jindal RM, Brown CD, Kimmel PL. Depression is an important contributor to low medication adherence in hemodialyzed patients and transplant recipients. Kidney Int. 2009 Jun;75(11):1223-1229. doi: 10.1038/ki.2009.51. Epub 2009 Feb 25.
- Cukor D, Ver Halen N, Asher DR, Coplan JD, Weedon J, Wyka KE, Saggi SJ, Kimmel PL. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2014 Jan;25(1):196-206. doi: 10.1681/ASN.2012111134. Epub 2013 Oct 10.
- Davison SN, Jhangri GS. The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients. J Pain Symptom Manage. 2005 Nov;30(5):465-73.
- Duarte PS, Miyazaki MC, Blay SL, Sesso R. Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients. Kidney Int. 2009 Aug;76(4):414-21. doi: 10.1038/ki.2009.156. Epub 2009 May 20.
- Glassman AH, O'Connor CM, Califf RM, Swedberg K, Schwartz P, Bigger JT Jr, Krishnan KR, van Zyl LT, Swenson JR, Finkel MS, Landau C, Shapiro PA, Pepine CJ, Mardekian J, Harrison WM, Barton D, Mclvor M; Sertraline Antidepressant Heart Attack Randomized Trial (SADHEART) Group. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002 Aug 14;288(6):701-9. Erratum in: JAMA 2002 Oct 9;288(14):1720.
- Hedayati SS, Bosworth HB, Briley LP, Sloane RJ, Pieper CF, Kimmel PL, Szczech LA. Death or hospitalization of patients on chronic hemodialysis is associated with a physician-based diagnosis of depression. Kidney Int. 2008 Oct;74(7):930-6. doi: 10.1038/ki.2008.311. Epub 2008 Jun 25.
- Hedayati SS, Bosworth HB, Kuchibhatla M, Kimmel PL, Szczech LA. The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients. Kidney Int. 2006 May;69(9):1662-8.
- Hedayati SS, Minhajuddin AT, Toto RD, Morris DW, Rush AJ. Validation of depression screening scales in patients with CKD. Am J Kidney Dis. 2009 Sep;54(3):433-9. doi: 10.1053/j.ajkd.2009.03.016. Epub 2009 Jun 3.
- Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney Int. 2000 May;57(5):2093-8.
- Kutner NG, Zhang R, McClellan WM, Cole SA. Psychosocial predictors of non-compliance in haemodialysis and peritoneal dialysis patients. Nephrol Dial Transplant. 2002 Jan;17(1):93-9.
- Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585.
- System, U.S.R.D., US Department of Public Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, 2012.
- Weisbord SD, Fried LF, Arnold RM, Fine MJ, Levenson DJ, Peterson RA, Switzer GE. Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol. 2005 Aug;16(8):2487-94. Epub 2005 Jun 23.
- Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. Epub 2007 Aug 8.
- Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA; STARD Investigators. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006 Mar;12(2):71-9.
Responsible Party:
Rajnish Mehrotra,
Professor of Medicine, Division of Nephrology,
University of Washington
ClinicalTrials.gov Identifier:
NCT02358343
Other Study ID Numbers:
- 48647
First Posted:
Feb 6, 2015
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019
Keywords provided by Rajnish Mehrotra,
Professor of Medicine, Division of Nephrology,
University of Washington
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants screened at 3 sites in the United States. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Engagement Interview | Control Visit | Cognitive Behavioral Therapy | Antidepressant Drug Therapy | Observational Cohort |
|---|---|---|---|---|---|
| Arm/Group Description | An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home. | A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial. | Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT is administered while the patient is undergoing hemodialysis unless alternative arrangements preferred by participant. During the course of intervention, study subjects undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12). | Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This protocol establishes the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks. | Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C. |
| Period Title: Screening Intervention | |||||
| STARTED | 92 | 92 | 0 | 0 | 0 |
| COMPLETED | 86 | 84 | 0 | 0 | 0 |
| NOT COMPLETED | 6 | 8 | 0 | 0 | 0 |
| Period Title: Screening Intervention | |||||
| STARTED | 0 | 0 | 60 | 60 | 20 |
| COMPLETED | 0 | 0 | 55 | 58 | 18 |
| NOT COMPLETED | 0 | 0 | 5 | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Engagement Interview | Control Visit | Cognitive Behavioral Therapy | Antidepressant Drug Therapy | Obsevational Cohort | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home. | A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial. | Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects. | Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study. | Total of all reporting groups |
| Overall Participants | 92 | 92 | 60 | 60 | 20 | 324 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
52
(14)
|
53
(12)
|
53
(13)
|
|||
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
50
(13)
|
53
(12)
|
53
(13)
|
52
(13)
|
||
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
42
45.7%
|
35
38%
|
77
128.3%
|
|||
| Male |
50
54.3%
|
57
62%
|
107
178.3%
|
|||
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
27
29.3%
|
25
27.2%
|
7
11.7%
|
59
98.3%
|
||
| Male |
33
35.9%
|
35
38%
|
13
21.7%
|
81
135%
|
||
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
27
29.3%
|
22
23.9%
|
49
81.7%
|
|||
| Not Hispanic or Latino |
65
70.7%
|
69
75%
|
134
223.3%
|
|||
| Unknown or Not Reported |
0
0%
|
1
1.1%
|
1
1.7%
|
|||
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
14
15.2%
|
20
21.7%
|
5
8.3%
|
39
65%
|
||
| Not Hispanic or Latino |
46
50%
|
39
42.4%
|
15
25%
|
100
166.7%
|
||
| Unknown or Not Reported |
0
0%
|
1
1.1%
|
0
0%
|
1
1.7%
|
||
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
7
7.6%
|
8
8.7%
|
15
25%
|
|||
| Asian |
2
2.2%
|
5
5.4%
|
7
11.7%
|
|||
| Native Hawaiian or Other Pacific Islander |
3
3.3%
|
3
3.3%
|
6
10%
|
|||
| Black or African American |
21
22.8%
|
32
34.8%
|
53
88.3%
|
|||
| White |
48
52.2%
|
29
31.5%
|
77
128.3%
|
|||
| More than one race |
2
2.2%
|
3
3.3%
|
5
8.3%
|
|||
| Unknown or Not Reported |
9
9.8%
|
12
13%
|
21
35%
|
|||
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
3
3.3%
|
6
6.5%
|
1
1.7%
|
10
16.7%
|
||
| Asian |
1
1.1%
|
2
2.2%
|
3
5%
|
6
10%
|
||
| Native Hawaiian or Other Pacific Islander |
4
4.3%
|
0
0%
|
0
0%
|
4
6.7%
|
||
| Black or African American |
19
20.7%
|
15
16.3%
|
6
10%
|
40
66.7%
|
||
| White |
24
26.1%
|
28
30.4%
|
8
13.3%
|
60
100%
|
||
| More than one race |
2
2.2%
|
0
0%
|
2
3.3%
|
4
6.7%
|
||
| Unknown or Not Reported |
7
7.6%
|
9
9.8%
|
0
0%
|
16
26.7%
|
||
| Dialysis Vintage (months) [Median (Inter-Quartile Range) ] | ||||||
| Median (Inter-Quartile Range) [months] |
32
|
28
|
31
|
|||
| Dialysis Vintage (months) [Median (Inter-Quartile Range) ] | ||||||
| Median (Inter-Quartile Range) [months] |
30
|
32
|
21
|
31
|
||
Outcome Measures
| Title | Number of Participants Who Initiated Depression Treatment |
|---|---|
| Description | The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition. This will be defined as one of the following: Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia. Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia. |
| Time Frame | within four weeks of engagement interview or control visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Engagement Interview | Control Visit |
|---|---|---|
| Arm/Group Description | Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same. Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well. | Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial. |
| Measure Participants | 86 | 84 |
| Count of Participants [Participants] |
57
62%
|
54
58.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.77 |
| Comments | a priori threshold for significance is 0.05. | |
| Method | Likelihood Ratio Test | |
| Comments | Likelihood ratio test obtained from logistic regression analysis adjusting for site | |
| Title | QIDS-C Score |
|---|---|
| Description | The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups. |
| Time Frame | Week 12 of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy | Observational Cohort |
|---|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT will be administered while the patient is undergoing hemodialysis; however, alternative arrangements will be made upon individual patient's preferences. Cognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. Antidepressant Drug Therapy: The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, | Participants not accepting treatment but consented to be followed. |
| Measure Participants | 55 | 58 | 18 |
| Mean (95% Confidence Interval) [score on a scale] |
8.1
|
5.9
|
7.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | a priori threshold for significance is 0.05. | |
| Method | Wald Test | |
| Comments | The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.84 | |
| Confidence Interval |
(2-Sided) 95% -3.54 to -0.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT). | |
| Title | Number of Participants Who Accepted Depression Treatment |
|---|---|
| Description | The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment. This will be measured by the patient's intent and will be defined as one of the following: Signing the informed consent to be randomly assigned to individual CBT or drug therapy Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community. Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia. |
| Time Frame | within two weeks of engagement interview or control visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Screening Intervention Period. Two participants who died both consented to treatment within the clinical trial and therefore were counted as non-missing for accepting treatment outcome by definition even though they did not complete the study. |
| Arm/Group Title | Engagement Interview | Control Visit |
|---|---|---|
| Arm/Group Description | Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same. Engagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well. | Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial. |
| Measure Participants | 86 | 86 |
| Count of Participants [Participants] |
70
76.1%
|
70
76.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | a priori threshold for significance is 0.05. | |
| Method | Likelihood Ratio Test | |
| Comments | Likelihood Ratio Test from logistic regression analysis adjusting for clinical site. | |
| Title | BDI-II |
|---|---|
| Description | Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 5 participants in the CBT arm and 2 participants in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 48 | 51 |
| Mean (95% Confidence Interval) [score on a scale] |
18.7
|
14.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.7 | |
| Confidence Interval |
(2-Sided) 95% -7.4 to -0.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | GAD-7 |
|---|---|
| Description | Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 4 participants in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 50 | 49 |
| Mean (95% Confidence Interval) [score on a scale] |
7.5
|
6.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.2 | |
| Confidence Interval |
(2-Sided) 95% -3.1 to 0.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | Sheehan Disability Scale |
|---|---|
| Description | range 0-30, higher scores indicate worse disability |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 1 participant in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 50 | 52 |
| Mean (95% Confidence Interval) [score on a scale] |
15.2
|
11.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.1 | |
| Confidence Interval |
(2-Sided) 95% -6.2 to -0.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | SF-36 Energy/Vitality |
|---|---|
| Description | Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the CBT arm and 4 participants in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 51 | 49 |
| Mean (95% Confidence Interval) [score on a scale] |
39.2
|
53
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.2 | |
| Confidence Interval |
(2-Sided) 95% 1.3 to 19.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | Global Quality of Life Scale |
|---|---|
| Description | range 0-10, higher scores indicate better quality of life |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 53 | 53 |
| Mean (95% Confidence Interval) [score on a scale] |
5.6
|
6.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% -0.2 to 1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | Satisfaction With Life Scale |
|---|---|
| Description | range 1-35, higher scores indicate better satisfaction |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 53 | 52 |
| Mean (95% Confidence Interval) [score on a scale] |
16.8
|
20.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.6 | |
| Confidence Interval |
(2-Sided) 95% 0.1 to 5.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | Perceived Social Support |
|---|---|
| Description | Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 53 | 51 |
| Mean (95% Confidence Interval) [score on a scale] |
4.7
|
4.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 0.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | PSQI |
|---|---|
| Description | Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 11 participants in the CBT arm and 13 participants in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 42 | 40 |
| Mean (95% Confidence Interval) [score on a scale] |
9.5
|
6.8
|
| Title | Exercise |
|---|---|
| Description | Single item activity measure, range 1-6, higher indicates less activity |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 53 | 52 |
| Mean (95% Confidence Interval) [score on a scale] |
3.5
|
3.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 0.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | Percentage of Dialysis Treatment Sessions Skipped and/or Shortened |
|---|---|
| Description | Treatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment. |
| Time Frame | Over 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 55 | 58 |
| Mean (95% Confidence Interval) [percentage of sessions skipped/shortened] |
22.2
|
17.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.55 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator). | |
| Title | Percent Inter-dialytic Weight Gain |
|---|---|
| Description | Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| In addition to participants withdrawn / died, 11 participants were missing average weight gain at week 12: 3 in CBT arm and 8 in Drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 52 | 50 |
| Mean (95% Confidence Interval) [percentage of body weight] |
2.6
|
2.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to 0.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
| Title | Serum Phosphorus Level |
|---|---|
| Description | Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| In addition to participants withdrawn / died, 8 participants were missing serum phosphorus level at week 12: 3 in CBT arm and 5 in Drug arm. |
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy |
|---|---|---|
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. |
| Measure Participants | 52 | 53 |
| Mean (95% Confidence Interval) [mg/dl] |
6.1
|
6.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Engagement Interview, Control Visit |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120). | |
Adverse Events
| Time Frame | Participants followed from randomization to treatment to 30 days after end of treatment period (4 months). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit. | |||
| Arm/Group Title | Cognitive Behavioral Therapy | Antidepressant Drug Therapy | ||
| Arm/Group Description | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). | The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol. | ||
All Cause Mortality |
||||
| Cognitive Behavioral Therapy | Antidepressant Drug Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/60 (3.3%) | 0/60 (0%) | ||
Serious Adverse Events |
||||
| Cognitive Behavioral Therapy | Antidepressant Drug Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/60 (18.3%) | 14/60 (23.3%) | ||
| Blood and lymphatic system disorders | ||||
| Unknown System Organ Class | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Cardiac disorders | ||||
| Hypertension | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Afib | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Syncope | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Volume overload | 2/60 (3.3%) | 2 | 2/60 (3.3%) | 2 |
| Cardiovascular event | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Cardiac arrest | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Gastrointestinal disorders | ||||
| Rectal bleeding | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Hematemesis | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Small bowel obstruction | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Gastroparesis | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Infections and infestations | ||||
| Cellulitis | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Catheter infection | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Healthcare-associated pneumonia | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Clostridium difficile infection | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Pneumonia | 1/60 (1.7%) | 2 | 0/60 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Leg fracture | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Leg amputation | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Nervous system disorders | ||||
| Vertigo, facial palsy (shingles) | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Convulsions | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Reproductive system and breast disorders | ||||
| Vaginal bleeding | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 0/60 (0%) | 0 | 2/60 (3.3%) | 2 |
| Dyspnea | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Surgical and medical procedures | ||||
| Kidney transplant | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Arteriovenous grafts vascular access surgery | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Vascular disorders | ||||
| Leg ischemia | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Arteriovenous graft malfunction | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Renal artery aneurysm | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Cognitive Behavioral Therapy | Antidepressant Drug Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/60 (6.7%) | 12/60 (20%) | ||
| Cardiac disorders | ||||
| Dizziness | 0/60 (0%) | 0 | 5/60 (8.3%) | 5 |
| Gastrointestinal disorders | ||||
| Vomiting | 4/60 (6.7%) | 4 | 6/60 (10%) | 7 |
| General disorders | ||||
| Fatigue | 0/60 (0%) | 0 | 5/60 (8.3%) | 6 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Tessa Rue, Biostatistician |
|---|---|
| Organization | Center for Biomedical Statistics, University of Washington |
| Phone | 206-543-4246 |
| ruet@uw.edu |
Responsible Party:
Rajnish Mehrotra,
Professor of Medicine, Division of Nephrology,
University of Washington
ClinicalTrials.gov Identifier:
NCT02358343
Other Study ID Numbers:
- 48647
First Posted:
Feb 6, 2015
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019