Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Study Details
Study Description
Brief Summary
This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent and has dramatic consequences on the quality of life and health of affected patients. Due to the complex interrelation between these conditions, patients often experience both psychological and physiological difficulties. Furthermore, Veterans with diabetes and depressive symptoms in rural settings have limited access to care. Interventions that reach Veterans in rural / community-based primary care are needed, especially those that blend treatment strategies for physical and emotional health.
Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6 and 12 month follow-up.
Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured by PHQ-9 scores) than will EUC.
Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significant greater improvements in HbA1c and PHQ-9 compared with EUC participants.
Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for all enrolled patients (regardless of intervention group assignment). Potential mediating and moderating variables include patient-level (clinical factors-diabetes distress and self-efficacy and sociodemographics) and facility-level factors (availability of medical and mental health services by clinical site).
Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm. Intervention factors include adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment implementation (e.g., goal setting quality and self-management behaviors) as well as any significant predictors obtained from Aim 1a.
Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention processes within a VA CBOC using the REAIM framework for evaluating effectiveness of behavioral interventions.
Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled study participants with the characteristics of all potentially eligible patients at each CBOC.
Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians' perceptions of behavioral coaches, patients' use of action plans, and responses to coaches' recommendations in preparation for future implementation
Project Methods: The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period. Coaches will use a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Participants' primary care providers will be notified about session discussions and the resultant goals and action plans. Both groups will receive only usual primary care during the subsequent 6 months maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. Changes in measurements from baseline will be compared between groups. Analytic evaluations of intervention mediators/moderators and implementation will also be conducted at 6 and 12 months follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: HOPE The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. |
Behavioral: Healthy Outcomes through Patient Empowerment (HOPE)
HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.
|
| Active Comparator: Arm 2: EUC The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. |
Behavioral: Enhanced Usual Care
All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.
|
Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1C [Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.]
Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.
- Change in Patient Health Questionnaires-9 During Intervention [PHQ-9 will be assessed at baseline, 6-, and 12- months.]
The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent "minimal symptoms" of depression; 10 - 14 represent "minor depression", dysthymia, or major depression - mild; 15 - 19 represent "major depression, moderately severe"; and scores of 20 and above is considered "major depression, severe." Participants with that scored a 10 or above were eligible for the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
-
as well as MEDVAMC patients living >20 miles from the hospital who face similar distance related treatment barriers
Participants must have:
-
a diagnosis of diabetes mellitus
-
an average HbA1c level >7.5% in the prior 6 months
-
clinically significant symptoms of depression
-
Verification of diabetes mellitus diagnoses will be based on data collected from the VA data warehouse.
-
To verify that participants meet the depression criteria, the investigators will use participant self-report of clinically significant depressive symptoms according to the PHQ-9, where a score of greater than/equal to 10 on the PHQ-9 will signify a clinically meaningful symptom burden.
Exclusion Criteria:
-
The investigators will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
-
Specific exclusion criteria are:
-
lack of regular access to a telephone
-
significant cognitive impairment (three or more errors) on an established six-item screening exam
-
meeting criteria for bipolar, psychotic, or substance-abuse disorders
-
presence of uncorrected hearing or vision impairment
-
their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
-
they live within 20 miles of the MEDVAMC.
-
Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
-
Patients receiving mental health services at the time of study recruitment will not be excluded.
-
All mental health treatments and health service-use characteristics will be included in study analyses as covariates.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Aanand D Naik, MD BA, Michael E. DeBakey VA Medical Center, Houston, TX
- Principal Investigator: Jeffrey Cully, PhD MEd, Michael E. DeBakey VA Medical Center, Houston, TX
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 10-135
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | There were a total of 225 participants enrolled into the study. Consent occurred at baseline and participants were eligible if they scored a 10 or greater on the PHQ-9 and an A1C of 7.5 or greater. If a participant didn't meet these criteria then they were not randomized into the study. |
| Arm/Group Title | Arm 1: HOPE | Arm 2: EUC |
|---|---|---|
| Arm/Group Description | The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period. | The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. |
| Period Title: Overall Study | ||
| STARTED | 136 | 89 |
| COMPLETED | 90 | 68 |
| NOT COMPLETED | 46 | 21 |
Baseline Characteristics
| Arm/Group Title | Arm 1: HOPE | Arm 2: EUC | Total |
|---|---|---|---|
| Arm/Group Description | The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period. | The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. | Total of all reporting groups |
| Overall Participants | 136 | 89 | 225 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.6
(8.4)
|
60.8
(8.0)
|
61.9
(8.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
11%
|
8
9%
|
23
10.2%
|
| Male |
121
89%
|
81
91%
|
202
89.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
73
53.7%
|
51
57.3%
|
124
55.1%
|
| Black |
41
30.1%
|
16
18%
|
57
25.3%
|
| Hispanic |
12
8.8%
|
11
12.4%
|
23
10.2%
|
| Other |
2
1.5%
|
4
4.5%
|
6
2.7%
|
| More than 1 race |
8
5.9%
|
7
7.9%
|
15
6.7%
|
Outcome Measures
| Title | Change in Hemoglobin A1C |
|---|---|
| Description | Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled. |
| Time Frame | Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each timepoint decreased due to non-completion of the A1C blood draw by participants. |
| Arm/Group Title | Arm 1: HOPE | Arm 2: EUC |
|---|---|---|
| Arm/Group Description | The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period. | The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. |
| Measure Participants | 136 | 89 |
| Baseline |
9.2
(1.4)
|
9.3
(1.5)
|
| 6-Months |
9.1
(1.7)
|
8.7
(1.7)
|
| 12-Months |
8.7
(1.6)
|
8.9
(2)
|
| Title | Change in Patient Health Questionnaires-9 During Intervention |
|---|---|
| Description | The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent "minimal symptoms" of depression; 10 - 14 represent "minor depression", dysthymia, or major depression - mild; 15 - 19 represent "major depression, moderately severe"; and scores of 20 and above is considered "major depression, severe." Participants with that scored a 10 or above were eligible for the study. |
| Time Frame | PHQ-9 will be assessed at baseline, 6-, and 12- months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed at each timepoint decreased due to non-completion of the assessment by participants. |
| Arm/Group Title | Arm 1: HOPE | Arm 2: EUC |
|---|---|---|
| Arm/Group Description | The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period. | The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. |
| Measure Participants | 136 | 89 |
| baseline |
15.8
(4.2)
|
16.2
(4)
|
| 6 Months |
10.9
(6.1)
|
12.4
(6)
|
| 12 Months |
10.1
(6.9)
|
12.6
(6.5)
|
Adverse Events
| Time Frame | Adverse event data were collected at 6 and 12 months at the time of assessments. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm 1: HOPE | Arm 2: EUC | ||
| Arm/Group Description | The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals. Healthy Outcomes through Patient Empowerment (HOPE): HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period. | The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions. Enhanced Usual Care: All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care. | ||
All Cause Mortality |
||||
| Arm 1: HOPE | Arm 2: EUC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/136 (0.7%) | 3/89 (3.4%) | ||
Serious Adverse Events |
||||
| Arm 1: HOPE | Arm 2: EUC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/136 (0.7%) | 0/89 (0%) | ||
| Infections and infestations | ||||
| Foot Sore | 1/136 (0.7%) | 1 | 0/89 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Arm 1: HOPE | Arm 2: EUC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/136 (0%) | 0/89 (0%) | ||
Limitations/Caveats
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 | Aanand, Naik, MD |
|---|---|
| Organization | Department of Veteran Affairs |
| Phone | 713-794-8541 |
| anaik@bcm.edu |
- IIR 10-135