N/A
N=140
Improving Mood in Veterans in Primary Care
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02276807 ↗Enrolled (actual)
140
Serious AEs
8.6%
Results posted
Jun 2019
Primary outcome: Primary: Change From Baseline in Depressive Symptoms at 12 Weeks — 15.68; 15.93; 11.40; 12.56 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Behavioral Activation (Behavioral); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Depressive Symptoms at 12 Weeks |
15.68; 15.93; 11.40; 12.56 | <0.05 sig |
| SECONDARY Change From Baseline in Quality of Life at 12 Weeks |
36.18; 34.02; 45.83; 36.68 | <0.05 sig |
| SECONDARY Change From Baseline in Sleep Disturbances at 12 Weeks |
17.07; 16.48; 15.95; 15.77 | <0.05 sig |
| SECONDARY Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks |
21.91; 20.78; 24.19; 21.17 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02276807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.