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Trial record 16 of 100 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

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

Tracking Information
First Submitted Date  ICMJE June 1, 2015
First Posted Date  ICMJE June 9, 2015
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE December 1, 2015
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
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  ICMJE Same as current
Change History Complete list of historical versions of study NCT02466126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • 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  ICMJE
 (submitted: June 4, 2015)
  • 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-36) - 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-36 will be used to measure a participant's functional status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Official Title  ICMJE Effectiveness 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: bCBT
  • 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.
Publications * 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. 2018 Nov 26. doi: 10.1093/tbm/iby116. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
232
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466126
Other Study ID Numbers  ICMJE IIR 13-315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Cully, PhD MEd Michael E. DeBakey VA Medical Center, Houston, TX
PRS Account VA Office of Research and Development
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP