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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bCBT/Direct Referral | Experimental | 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. |
|
| Enhanced Usual Care (EUC) | No Intervention | Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bCBT | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | 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. | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | 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. | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Cully, PhD MEd | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma | 73104-5007 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30476315 | Result | Johnson AL, Ecker AH, Fletcher TL, Hundt N, Kauth MR, Martin LA, Curran GM, Cully JA. Increasing the impact of randomized controlled trials: an example of a hybrid effectiveness-implementation design in psychotherapy research. Transl Behav Med. 2020 Aug 7;10(3):629-636. doi: 10.1093/tbm/iby116. | |
| 31201653 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 4 Month Assessment |
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| 8 Month Assessment |
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| 12 Month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
|
Adverse events were monitored for a 12 month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). |
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Study recruitment was hampered by a natural event, Hurricane Harvey. The event significantly slowed recruitment as part of the impact of the storm which hit the Houston area in August of 2017. The overall recruitment number was decreased to offset the better than expected retention of Veterans in the study. Re-calculated power analyses indicated that with our improved retention rates the study would require 189 Veteran participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Cully | Department of Veterans Affairs, Micheal E. DeBakey VAMC | 713-794-8526 | Jeffrey.Cully@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2018 | Jun 25, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 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. | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
| Michael E. DeBakey VA Medical Center, Houston, TX |
| Houston |
| Texas |
| 77030-4211 |
| United States |
| Brandt CP, Deavers F, Hundt NE, Fletcher TL, Cully JA. The Impact of Integrating Physical Health into a Brief CBT Approach for Medically Ill Veterans. J Clin Psychol Med Settings. 2020 Jun;27(2):285-294. doi: 10.1007/s10880-019-09634-2. |
| 38861659 | Derived | Ecker AH, Shivaji S, Plasencia M, Kauth MR, Hundt NE, Fletcher TL, Sansgiry S, Cully JA. The role of symptom reduction in improving health-related quality of life through brief cognitive behavioral therapy. Psychother Res. 2025 Jul;35(6):972-980. doi: 10.1080/10503307.2024.2349992. Epub 2024 Jun 11. |
| 34156589 | Derived | Rassu FS, Sansgiry S, Hundt NE, Kunik ME, Cully JA. Presence of PTSD is Associated with Clinical and Functional Impact in Veterans with Depression Treated in Community-Based Clinics. J Clin Psychol Med Settings. 2022 Mar;29(1):220-229. doi: 10.1007/s10880-021-09796-y. Epub 2021 Jun 22. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| PHQ-9 | The Patient Health Questionnaire (PHQ-9) is a measure used to access the level of depression a person is experiencing. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing. The measure was administered over the phone by an independent evaluator. | Count of Participants | Participants |
|
| SF-12 | 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. | The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory (BDI) | 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. | The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations. | Mean | Standard Deviation | units on a scale |
|
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).
| OG001 | 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. |
|
|
| Secondary | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
|
|
|
| Secondary | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. |
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| 0 |
| 109 |
| 0 |
| 109 |
| 0 |
| 109 |
| EG001 | 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. | 0 | 80 | 0 | 80 | 0 | 80 |
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| Severe (20-27) |
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| 4 Month |
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| 8 Month |
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| 12 Month |
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| Baseline: Mental Health |
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| 4 Month: Physical Health |
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| 4 Month: Mental Health |
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| 8 Month: Physical Health |
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| 8 Month: Mental Health |
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| 12 Month: Physical Health |
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| 12 Month: Mental Health |
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