Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs

NCT ID: NCT02466126

Last Updated: 2023-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

bCBT

Intervention Type 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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Cully, PhD MEd

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center, Houston, TX

Locations

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Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma, United States

Site Status

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30476315 (View on PubMed)

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.

Reference Type RESULT
PMID: 31201653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38861659 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34156589 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IIR 13-315

Identifier Type: -

Identifier Source: org_study_id

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