NCT02276807

Improving Mood in Veterans in Primary Care

Completed NA Results posted Last updated 1 July 2019

What this trial tests

NA trial testing Brief Behavioral Activation in Depression in 140 participants. Completed in 31 July 2018.

Timeline

23 March 2015

Primary endpoint
1 March 2018

31 July 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	140
Start date	23 March 2015
Primary completion	1 March 2018
Estimated completion	31 July 2018
Sites	3 locations across United States

Drugs / interventions tested

• Brief Behavioral Activation
• Usual Care

Conditions studied

• Depression — all drugs for Depression →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Depressive Symptoms at 12 Weeks Primary · 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.

PHQ-9 Total Score at Baseline

Group	Value	95% CI
Brief Behavioral Activation	15.68	± 3.94
Usual Care	15.93	± 4.38

PHQ-9 Total Score at Week 12

Group	Value	95% CI
Brief Behavioral Activation	11.40	± 4.94
Usual Care	12.56	± 5.40

Change From Baseline in Quality of Life at 12 Weeks Secondary · 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.

Total Score at Baseline

Group	Value	95% CI
Brief Behavioral Activation	36.18	± 15.43
Usual Care	34.02	± 17.84

Total Score at Week 12

Group	Value	95% CI
Brief Behavioral Activation	45.83	± 19.53
Usual Care	36.68	± 19.61

Change From Baseline in Sleep Disturbances at 12 Weeks Secondary · 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.

Total Score at Baseline

Group	Value	95% CI
Brief Behavioral Activation	17.07	± 7.18
Usual Care	16.48	± 6.66

Total Score at Week 12

Group	Value	95% CI
Brief Behavioral Activation	15.95	± 7.48
Usual Care	15.77	± 6.74

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

Total Score at Baseline

Group	Value	95% CI
Brief Behavioral Activation	21.91	± 3.56
Usual Care	20.78	± 4.01

Total Score at Week 12

Group	Value	95% CI
Brief Behavioral Activation	24.19	± 3.93
Usual Care	21.17	± 4.91

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

Total Score at Baseline

Group	Value	95% CI
Brief Behavioral Activation	2.02	± 4.27
Usual Care	1.69	± 4.13

Total Score at Week 12

Group	Value	95% CI
Brief Behavioral Activation	1.19	± 3.49
Usual Care	1.13	± 4.18

Adverse events — posted to ClinicalTrials.gov

Time frame: Systematically, serious adverse event data was collected during the medical record review conducted at 12 and 24-week assessments. However, research staff also noted events if participant reported them during brief assessments conducted during the 12-week intervention period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brief Behavioral Activation

Serious: 8/68 (12%)

Deaths: 0/68

Usual Care

Serious: 4/72 (6%)

Deaths: 0/72

Serious adverse events (4 terms)

Reaction	System	Brief Behavioral Activation	Usual Care
Hospitalization Due to Injury	Injury, poisoning and procedural complications	—	—
Hospitalization due to	Surgical and medical procedures	—	—
Hospitalization due to Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalization due to Psychiatric Disorders	Psychiatric disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Brief Behavioral Activation	Usual Care
Emergency Room Visit	Injury, poisoning and procedural complications	—	—
Clinically Significant Increase in Depressive Symptoms	Psychiatric disorders	—	—
Outpatient Surgery	Surgical and medical procedures	—	—
Distressed Participant Unrelated to Study	Psychiatric disorders	—	—

Most-reported serious reactions: Hospitalization Due to Injury, Hospitalization due to, Hospitalization due to Pneumonia, Hospitalization due to Psychiatric Disorders.

Data from ClinicalTrials.gov NCT02276807 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation.
   Funderburk JS, Pigeon WR, Shepardson RL, Wade M, et al · · 2021 · cited 13× · PMID 33516082 · DOI 10.1016/j.jad.2021.01.033