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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: bCBT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Darrell Zeno, MS BS (713) 794-8678 darrell.zeno@va.gov
Contact: Andrew Robinson, MA (713) 791-1414 ext 10262 Andrew.Robinson@va.gov

Locations
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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    darrell.zeno@va.gov   
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         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jeffrey Cully, PhD MEd Michael E. DeBakey VA Medical Center, Houston, TX

Additional Information:
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02466126     History of Changes
Other Study ID Numbers: IIR 13-315
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Depression
brief Cognitive Behavioral Therapy (bCBT)
Randomized Controlled Trial
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms