Improving Mood in Veterans in Primary Care
RCT of Behavioral Activation for Depression and Suicidality in Primary Care
1 other identifier
interventional
140
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Mar 2015
Typical duration for not_applicable depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 28, 2014
CompletedStudy Start
First participant enrolled
March 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedResults Posted
Study results publicly available
June 14, 2019
CompletedJuly 1, 2019
June 1, 2019
2.9 years
October 8, 2014
March 1, 2019
June 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change From Baseline in Quality of Life at 12 Weeks
Baseline and 12 weeks
Change From Baseline in Sleep Disturbances at 12 Weeks
Baseline and 12 weeks
Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
Baseline and 12 weeks
Other Outcomes (1)
Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks
Baseline and 12 weeks
Study Arms (2)
Brief Behavioral Activation
EXPERIMENTALThis 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.
Usual Care
ACTIVE COMPARATORThis is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms.
Interventions
This is a 4-session individual workshop using behavioral activation techniques.
Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215, United States
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, 14424, United States
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210, United States
Related Publications (1)
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.
PMID: 33516082DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limited to a Veteran population willing to engage in a clinical trial, lack of ability to clarify the impact of BA-PC from the impact of BA-PC with regular assessment of depressive symptoms which likely decreased power of sample size unexpectedly
Results Point of Contact
- Title
- Dr. Jennifer Funderburk
- Organization
- VA Center for Integrated Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Schum Funderburk, PhD
Syracuse VA Medical Center, Syracuse, NY
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 28, 2014
Study Start
March 23, 2015
Primary Completion
March 1, 2018
Study Completion
July 31, 2018
Last Updated
July 1, 2019
Results First Posted
June 14, 2019
Record last verified: 2019-06