Clinical trial NCT02276807: Improving Mood in Veterans in Primary Care
Official title: RCT of Behavioral Activation for Depression and Suicidality in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Behavioral Symptoms
Mental Disorders
Depressive Disorder
suicidal ideation
primary health care
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-10-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Depressive Symptoms at 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Quality of Life at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Sleep Disturbances at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks
timeFrame: Baseline and 12 weeks
Locations:
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
city: Canandaigua
country: United States
facility: Canandaigua VA Medical Center, Canandaigua, NY
state: New York
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: Syracuse VA Medical Center, Syracuse, NY
name: Jennifer Schum Funderburk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Funderburk JS, Pigeon WR, Shepardson RL, Wade M, Acker J, Fivecoat H, Wray LO, Maisto SA. Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. J Affect Disord. 2021 Mar 15;283:11-19. doi: 10.1016/j.jad.2021.01.033. Epub 2021 Jan 14.