Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs

Conditions
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Depression

Intervention / Treatment
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* Behavioral: bCBT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bCBT/Direct Referral<br>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<br>* 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).<br>|
| No Intervention: Enhanced Usual Care (EUC)<br>Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, brief Cognitive Behavioral Therapy (bCBT), Randomized Controlled Trial