Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs (My Brief CBT)
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|ClinicalTrials.gov Identifier: NCT02466126|
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: bCBT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||232 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs|
|Actual Study Start Date :||December 1, 2015|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2020|
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.
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.
- Patient Health Questionnaire (PHQ-9); change is being assessed using a 4 timepoint process [ Time Frame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. ]The PHQ-9 will be used to measure a participant's level of depression.
- Beck Depression Inventory (BDI) - change is being assessed using a 4 timepoint process [ Time Frame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. ]Will be used a s a second measure to measure depression.
- Health Survey for Veterans (SF-12) - change is being assessed using a 4 timepoint process [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466126
|Contact: Darrell Zeno, MS BS||(713) email@example.com|
|Contact: Andrew Robinson, MA||(713) 791-1414 ext 10262||Andrew.Robinson@va.gov|
|United States, Oklahoma|
|Oklahoma City VA Medical Center, Oklahoma City, OK||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Kristen H Sorocco, PhD 405-456-1454 Kristen.Sorocco@va.gov|
|Sub-Investigator: Kristen H Sorocco, PhD|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Darrell Zeno, MS BS 713-794-8678 firstname.lastname@example.org|
|Contact: Andrew Robinson, MA (713) 791-1414 ext 10262 Andrew.Robinson@va.gov|
|Principal Investigator: Jeffrey Cully, PhD MEd|
|Sub-Investigator: Jennifer Bryan, PhD|
|Sub-Investigator: Lindsey Martin, PhD|
|Sub-Investigator: Mark E. Kunik, MD MPH|
|Sub-Investigator: Melinda A. Stanley, PhD|
|Sub-Investigator: Michael Kauth, PhD|
|Sub-Investigator: Natalie E Hundt, PhD|
|Sub-Investigator: Terri L. Fletcher, PhD|
|Principal Investigator:||Jeffrey Cully, PhD MEd||Michael E. DeBakey VA Medical Center, Houston, TX|