Improving Mood in Veterans in Primary Care

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-23

Study Completion Date

2018-07-31

Brief Summary

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The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a brief educational individual workshop that is meant to help Veterans better understand feelings of sadness and ways to improve their mood. This study is intended to evaluate and establish the workshop's effectiveness for use with Veterans in primary care settings.

The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month period of time. Approximately 144 Veterans will participate in the study. Using a procedure like the flip of a coin, the participants will have a one in two chance of receiving the brief educational workshop or treatment as usual condition.

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Detailed Description

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Background:

Depressive symptoms are the most common referral problem to integrated mental health providers within Veteran primary care clinics. Although there exist several empirically-based brief psychotherapies for depression in primary care, the most significant barrier to providing those psychotherapies is treatment duration (e.g., the treatments range from 6-8 sessions of 30-50 minutes) as it does not match typical treatment formats delivered by mental health providers working in primary care (i.e., 1-4 15-30 minute sessions). Therefore, this HSR\&D study titled, RCT of Behavioral Activation for Depression and Suicidality in Primary Care, will examine the effectiveness of a brief version of an existing efficacious longer treatment for depression, called behavioral activation.

Objectives:

The overarching objectives of this study are to: 1) examine whether a 4-session manualized behavioral activation intervention (BA-PC) compared to Treatment as Usual (TAU) is effective in reducing self-reported depressive symptoms and subjective secondary outcomes such as sleep impairment and quality of life; 2) examine patient satisfaction, engagement, and receptivity to a 4-session BA-PC; and 3) explore the impact of BA-PC on suicidal ideation.

Methods:

The study will achieve these objectives using a randomized, controlled trial study design that has two conditions (4-session BA-PC and Treatment as Usual). Veterans will be recruited from three VA primary care settings in the Western portion of VISN 2 (Syracuse, Rochester, and Buffalo). The primary inclusion criteria for the study will be a report of depressive symptoms by primary care patients, who are not currently engaged in psychological treatment for depression. A total of 136 Veterans will be targeted for randomization. All Veterans will be assessed every 2 weeks for changes in mood and more comprehensive assessments will be completed at 6, 12, and 24 weeks.

Status:

Recruitment has ended as of 2/26/18 with 140 participants being randomized. Follow-up will continue for another 24 weeks. We are preparing the data for analysis.

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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Brief Behavioral Activation

This is a 4-session individual workshop using behavioral activation techniques. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values.

Group Type EXPERIMENTAL

Brief Behavioral Activation

Intervention Type BEHAVIORAL

This is a 4-session individual workshop using behavioral activation techniques.

Usual Care

This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.

Interventions

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Brief Behavioral Activation

This is a 4-session individual workshop using behavioral activation techniques.

Intervention Type BEHAVIORAL

Usual Care

Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.

Intervention Type OTHER

Other Intervention Names

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Usual Care condition

Eligibility Criteria

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Inclusion Criteria

Veterans:

* aged 18 years
* seeking or receiving primary care services at the Syracuse, Canandaigua, or Buffalo VA Medical Centers
* reporting at least moderate depressive symptoms
* stable course of antidepression medications
* stable course of outpatient treatment for anxiety or substance use disorders

Exclusion Criteria

Veterans who are:

* unable to demonstrate an understanding of the informed consent
* non-English speaking
* reporting imminent risk of suicide
* have an unstable psychiatric condition
* currently involved in treatment for depression
* recently started antidepression medication or outpatient treatment for anxiety or substance use disorder
* currently involved or completed inpatient or intensive outpatient treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No