Clinical trial NCT02466126: Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Official title: Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
brief Cognitive Behavioral Therapy (bCBT)
Randomized Controlled Trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-06-09
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
timeFrame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Secondary outcomes:
measure: Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
timeFrame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
measure: Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
timeFrame: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center, Oklahoma City, OK
state: Oklahoma
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Jeffrey Cully, PhD MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.