Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs

NCT02466126 | Completed Results DMC

• 1 other identifier: IIR 13-315
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

Depression; brief Cognitive Behavioral Therapy (bCBT); Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.

  The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing.

  Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.

Secondary Outcomes (2)

• Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process

  Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.

• Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process

  Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.

Study Arms (2)

bCBT/Direct Referral

EXPERIMENTAL

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

Enhanced Usual Care (EUC)

NO INTERVENTION

Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.

Interventions

bCBT BEHAVIORAL

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).

bCBT/Direct Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must have clinically significant symptoms of depression;
• must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.

You may not qualify if:

• cognitive impairment;
• presence of bipolar, psychotic or substance-abuse disorders.
• Veterans currently receiving psychotherapy WILL be excluded.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma, 73104-5007, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Related Publications (4)

• 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.

  PMID: 30476315 RESULT

• 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.

  PMID: 31201653 RESULT

• Ecker AH, Shivaji S, Plasencia M, Kauth MR, Hundt NE, Fletcher TL, Sansgiry S, Cully JA. The role of symptom reduction in improving health-related quality of life through brief cognitive behavioral therapy. Psychother Res. 2025 Jul;35(6):972-980. doi: 10.1080/10503307.2024.2349992. Epub 2024 Jun 11.

  PMID: 38861659 DERIVED

• 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.

  PMID: 34156589 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Study recruitment was hampered by a natural event, Hurricane Harvey. The event significantly slowed recruitment as part of the impact of the storm which hit the Houston area in August of 2017. The overall recruitment number was decreased to offset the better than expected retention of Veterans in the study. Re-calculated power analyses indicated that with our improved retention rates the study would require 189 Veteran participants.

Results Point of Contact

• Title: Dr. Jeffrey Cully
• Organization: Department of Veterans Affairs, Micheal E. DeBakey VAMC

Jeffrey.Cully@va.gov

713-794-8526

Study Officials

• Jeffrey Cully, PhD MEd

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 9, 2015
• Study Start: December 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 27, 2023
• Results First Posted: June 25, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)