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Completed

NCT Number: NCT02276807

Improving Mood in Veterans in Primary Care

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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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Western New York Healthcare System, Buffalo, NY, Buffalo, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Behavioral Activation

Behavioral

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

Usual Care

Other

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

Other names: Usual Care condition

Primary outcomes

  1. Change From Baseline in Depressive Symptoms at 12 Weeks

    Time frame: Baseline and 12 weeks

    The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms at baseline and 12 weeks. The minimum value is 0 and the maximum value is 27. Higher scores mean a worse outcome.

Secondary outcomes

  1. Change From Baseline in Quality of Life at 12 Weeks

    Time frame: Baseline and 12 weeks

    The investigators will use the Short Form-12 (SF-12) mental health domain to assess quality of life at baseline and 12 weeks. The minimum score is 0 and maximum score is 100. Higher scores mean better quality of life within mental health domain.

  2. Change From Baseline in Sleep Disturbances at 12 Weeks

    Time frame: Baseline and 12 weeks

    The investigators will use the Insomnia Severity Index (ISI) to assess sleep disturbances at baseline and 12 weeks. The minimum score is 0 and the maximum score is 28. Higher scores on ISI mean worse sleep.

  3. Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks

    Time frame: Baseline and 12 weeks

    The investigators will use the Environmental Observational Reward (EROS) scale to assess level of reward/positive mood at baseline and 12 weeks. The minimum score is 10 and the maximum score is 40. Higher scores mean increased level of positive mood obtained from environment.

Other outcomes

  1. Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks

    Time frame: Baseline and 12 weeks

    The investigators will use the Beck Scale for Suicidal Ideation to assess intensity of suicidal ideation within the past week at baseline and 12 weeks. The minimum score is 0 and the maximum score is 38. Higher scores mean worse suicidal ideation.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

RCT of Behavioral Activation for Depression and Suicidality in Primary Care

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2014
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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