Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs

ID: NCT02466126
Status: Recruiting
Phase: N/A
Start Date: December 01, 2015
First Submitted: June 01, 2015
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: United States
Conditions: Depression
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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.

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.
Condition or disease Intervention/treatment Phase

Depression

Behavioral: bCBT
Other Names
N/A

Tracking Information

First Submitted DateJune 01, 2015
Last Update Posted DateFebruary 23, 2018
Actual Start DateDecember 01, 2015
Anticipated Completion DateSeptember 30, 2019
Actual Primary Completion DateDecember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEffectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Official TitleEffectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
232
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Depression
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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).

Other Names
Study Groups/Cohorts
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.

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.

Study Arms
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).

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

Recruitment Information

Recruitment Status:Recruiting
Enrollment232
Completion DateSeptember 30, 2019
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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02466126
Other Study ID Numbers
IIR 13-315
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Jeffrey Cully, PhD MEd
Michael E. DeBakey VA Medical Center, Houston, TX