Improving Mood in Veterans in Primary Care

Depression Clinical Trial

Official title:

RCT of Behavioral Activation for Depression and Suicidality in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276807
• Other study ID #: IIR 14-047
• Status: Completed
• Phase: N/A
• Start date: March 23, 2015
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 31, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Brief Behavioral Activation
This is a 4-session individual workshop using behavioral activation techniques.

Other:
• Usual Care
Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York
United States	Canandaigua VA Medical Center, Canandaigua, NY	Canandaigua	New York
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the Level of Intensity of Suicidal Ideation at 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.	Baseline and 12 weeks
Primary	Change From Baseline in Depressive Symptoms at 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.	Baseline and 12 weeks
Secondary	Change From Baseline in Quality of Life at 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.	Baseline and 12 weeks
Secondary	Change From Baseline in Sleep Disturbances at 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.	Baseline and 12 weeks
Secondary	Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 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.	Baseline and 12 weeks

External Links

•   Click here for more information about this study: RCT of Behavioral Activation for Depression and Suicidality in Primary Care
•   The co-PI's are affiliated with the VA Center for Integrated Healthcare and this website describes current and past research projects similar to the one in this study.