MyBriefCBT: Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Depression is a serious health condition that places tremendous burden on patients and healthcare systems and is especially prevalent in Veterans. In 2008, the VHA released the Uniform Mental Health Services Handbook (Handbook 1160.01) in an effort to expand services for Veterans with depression, including those in primary care and CBOC settings.
The VA remains a national leader in mental health services, but the provision of psychotherapy within VA is limited, especially for rural Veterans and those cared for in CBOCs. The VA has invested significant resources to improve access to high-quality mental health care, including a rapid expansion into CBOCs. Currently, there is a need to work with clinicians and stakeholders to address practice barriers related to mental health practices in CBOCs. A recent survey of 4,200 mental health providers in VA found that, although robust expansion and improved quality of mental health care services has occurred, access to proven effective psychotherapies in CBOCs remains a focused area for improvement. The study will examine whether existing VA CBOC mental health clinicians, with training and support, can effectively administer a structured brief cognitive behavioral therapy (bCBT) intervention for Veterans with clinically elevated symptoms of depression.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: bCBT/Direct Referral A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. |
Behavioral: bCBT
The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
|
No Intervention: Enhanced Usual Care (EUC) Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
Outcome Measures
Primary Outcome Measures
- Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. [Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.]
The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing.
Secondary Outcome Measures
- Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process [Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.]
The measure will be used a s a second assessment to measure depression. Scores on the measure can range from 0 to 63. The higher the score the higher level of depression someone is experiencing.
- Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process [Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.]
SF-12 will be used to measure a participant's functional status. The SF-12V measures 8 concepts of health and can be summarized into summary component scores for physical (PCS) and mental (MCS) functioning. Scores can range from 0 - 100 and higher scores mean better functioning and quality of life.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
must have clinically significant symptoms of depression;
-
must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.
Exclusion Criteria:
-
cognitive impairment;
-
presence of bipolar, psychotic or substance-abuse disorders.
-
Veterans currently receiving psychotherapy WILL be excluded.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma | United States | 73104 |
2 | 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: Jeffrey Cully, PhD MEd, Michael E. DeBakey VA Medical Center, Houston, TX
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- IIR 13-315
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | bCBT/Direct Referral | Enhanced Usual Care (EUC) |
---|---|---|
Arm/Group Description | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
Period Title: Baseline | ||
STARTED | 109 | 80 |
COMPLETED | 109 | 80 |
NOT COMPLETED | 0 | 0 |
Period Title: Baseline | ||
STARTED | 109 | 80 |
COMPLETED | 93 | 71 |
NOT COMPLETED | 16 | 9 |
Period Title: Baseline | ||
STARTED | 93 | 71 |
COMPLETED | 86 | 68 |
NOT COMPLETED | 7 | 3 |
Period Title: Baseline | ||
STARTED | 86 | 68 |
COMPLETED | 85 | 66 |
NOT COMPLETED | 1 | 2 |
Baseline Characteristics
Arm/Group Title | bCBT/Direct Referral | Enhanced Usual Care (EUC) | Total |
---|---|---|---|
Arm/Group Description | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. | Total of all reporting groups |
Overall Participants | 109 | 80 | 189 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
59.1
(13.3)
|
56.9
(13.8)
|
58.3
(13.4)
|
Sex: Female, Male (Count of Participants) | |||
Female |
7
6.4%
|
11
13.8%
|
18
9.5%
|
Male |
102
93.6%
|
69
86.3%
|
171
90.5%
|
Race/Ethnicity, Customized (Count of Participants) | |||
White |
68
62.4%
|
55
68.8%
|
123
65.1%
|
African American |
19
17.4%
|
11
13.8%
|
30
15.9%
|
American Indian/Alaskan Native |
6
5.5%
|
1
1.3%
|
7
3.7%
|
Asian/Vietnamese |
1
0.9%
|
1
1.3%
|
2
1.1%
|
Hispanic/Latino |
11
10.1%
|
8
10%
|
19
10.1%
|
Multiple Race |
4
3.7%
|
3
3.8%
|
7
3.7%
|
Unknown |
0
0%
|
1
1.3%
|
1
0.5%
|
PHQ-9 (Count of Participants) | |||
Moderate (10-14) |
37
33.9%
|
32
40%
|
69
36.5%
|
Moderate severe (15-19) |
47
43.1%
|
28
35%
|
75
39.7%
|
Severe (20-27) |
25
22.9%
|
20
25%
|
45
23.8%
|
SF-12 (units on a scale) [Mean (Standard Deviation) ] | |||
SF - 12 PCS |
33.12
(11.54)
|
34.59
(13.12)
|
33.74
(12.21)
|
SF - 12 MCS |
37.17
(9.79)
|
34.43
(10.31)
|
36.02
(10.07)
|
Beck Depression Inventory (BDI) (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
25.65
(7.47)
|
26.34
(8.33)
|
25.93
(7.81)
|
Outcome Measures
Title | Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. |
---|---|
Description | The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing. |
Time Frame | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
Outcome Measure Data
Analysis Population Description |
---|
The overall number of participants for each group was contacted to complete follow up assessments. Some participants declined to complete the assessment at each time point. Reasons for not completing assessments included: participants not interested in completing, unable to contact, and withdrew from the study. The population analyzed during the follow-up period represents the participants that agreed to complete the assessments for that time period. |
Arm/Group Title | bCBT/Direct Referral | Enhanced Usual Care (EUC) |
---|---|---|
Arm/Group Description | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
Measure Participants | 109 | 80 |
Baseline |
16.40
(3.75)
|
16.34
(4.24)
|
4 Month |
11.74
(5.76)
|
14.94
(5.51)
|
8 Month |
12.79
(5.03)
|
14.74
(5.67)
|
12 Month |
12.99
(5.08)
|
14.14
(5.40)
|
Title | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process |
---|---|
Description | The measure will be used a s a second assessment to measure depression. Scores on the measure can range from 0 to 63. The higher the score the higher level of depression someone is experiencing. |
Time Frame | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
Outcome Measure Data
Analysis Population Description |
---|
The overall number of participants for each group was contacted to complete follow up assessments. Some participants declined to complete the assessment at each time point. Reasons for not completing assessments included: participants not interested in completing, unable to contact, and withdrew from the study. The population analyzed during the follow-up period represents the participants that agreed to complete the assessments for that time period. |
Arm/Group Title | bCBT/Direct Referral | Enhanced Usual Care (EUC) |
---|---|---|
Arm/Group Description | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
Measure Participants | 99 | 68 |
Baseline |
25.65
(7.47)
|
26.34
(8.33)
|
4 Month |
18.98
(10.41)
|
22.68
(10.07)
|
8 Month |
20.23
(9.39)
|
22.02
(10.89)
|
12 Month |
20.72
(9.38)
|
22.86
(10.99)
|
Title | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process |
---|---|
Description | SF-12 will be used to measure a participant's functional status. The SF-12V measures 8 concepts of health and can be summarized into summary component scores for physical (PCS) and mental (MCS) functioning. Scores can range from 0 - 100 and higher scores mean better functioning and quality of life. |
Time Frame | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
Outcome Measure Data
Analysis Population Description |
---|
The overall number of participants for each group was contacted to complete follow up assessments. Some participants declined to complete the assessment at each time point. Reasons for not completing assessments included: participants not interested in completing, unable to contact, and withdrew from the study. The population analyzed during the follow-up period represents the participants that agreed to complete the assessments for that time period. |
Arm/Group Title | bCBT/Direct Referral | Enhanced Usual Care (EUC) |
---|---|---|
Arm/Group Description | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
Measure Participants | 106 | 77 |
Baseline: Physical Health |
33.12
(11.54)
|
34.59
(13.12)
|
Baseline: Mental Health |
37.17
(9.79)
|
34.43
(10.31)
|
4 Month: Physical Health |
31.46
(10.05)
|
32.83
(12.21)
|
4 Month: Mental Health |
41.84
(12.58)
|
36.82
(10.03)
|
8 Month: Physical Health |
29.72
(10.25)
|
31.66
(12.05)
|
8 Month: Mental Health |
39.76
(11.38)
|
35.44
(11.37)
|
12 Month: Physical Health |
30.98
(10.91)
|
31.01
(11.87)
|
12 Month: Mental Health |
38.41
(10.89)
|
36.13
(11.27)
|
Adverse Events
Time Frame | Adverse events were monitored for a 12 month period. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | bCBT/Direct Referral | Enhanced Usual Care (EUC) | ||
Arm/Group Description | A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes. bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health). | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. | ||
All Cause Mortality |
||||
bCBT/Direct Referral | Enhanced Usual Care (EUC) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/80 (0%) | ||
Serious Adverse Events |
||||
bCBT/Direct Referral | Enhanced Usual Care (EUC) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/80 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
bCBT/Direct Referral | Enhanced Usual Care (EUC) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/80 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Dr. Jeffrey Cully |
---|---|
Organization | Department of Veterans Affairs, Micheal E. DeBakey VAMC |
Phone | 713-794-8526 |
Jeffrey.Cully@va.gov |
- IIR 13-315