Trial Outcomes & Findings for Improving Mood in Veterans in Primary Care (NCT NCT02276807)

NCT ID: NCT02276807

Last Updated: 2019-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 140 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2019-07-01

Participant Flow

Participants were recruited from three VA primary care clinics in Western New York from March 2015 through March 2018 . Eligible participants (i.e., age > 18 years of age, receiving services in those clinics, and reporting depressive symptoms) were identified via medical record review, study flyers posted in clinics, and direct referrals.

A two-part screening process identified those eligible to continue into the study based on additional set of eligibility criteria, such as at least moderate symptoms of depression and stable course of antidepressants or outpatient psychotherapy for anxiety, PTSD, or substance use.

Participant milestones

Measure	Brief Behavioral Activation This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Overall Study STARTED	68	72
Overall Study 12-week Assessment	57	63
Overall Study COMPLETED	50	55
Overall Study NOT COMPLETED	18	17

Reasons for withdrawal

Measure	Brief Behavioral Activation This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Overall Study Withdrawal by Subject	8	7
Overall Study Lost to Follow-up	10	10

Baseline Characteristics

Improving Mood in Veterans in Primary Care

Baseline characteristics by cohort

Measure	Brief Behavioral Activation n=68 Participants This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is a 4-session individual workshop using behavioral activation techniques.	Usual Care n=72 Participants This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.	Total n=140 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 14.9 • n=5 Participants	54.3 years STANDARD_DEVIATION 13.4 • n=7 Participants	53.0 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	66 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants	66 Participants n=7 Participants	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	49 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Patient Health Questionnaire-9 (PHQ-9)	16.0 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	15.9 units on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	16.0 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants
Beck Scale for Suicidal Ideation (SSI)	2.1 units on a scale STANDARD_DEVIATION 4.9 • n=5 Participants	1.8 units on a scale STANDARD_DEVIATION 4.1 • n=7 Participants	2.0 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who did not withdraw before week 12 and completed this questionnaire at week 12

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.

Outcome measures

Measure	Brief Behavioral Activation n=57 Participants This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care n=63 Participants This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Change From Baseline in Depressive Symptoms at 12 Weeks PHQ-9 Total Score at Baseline	15.68 score on a scale Standard Deviation 3.94	15.93 score on a scale Standard Deviation 4.38
Change From Baseline in Depressive Symptoms at 12 Weeks PHQ-9 Total Score at Week 12	11.40 score on a scale Standard Deviation 4.94	12.56 score on a scale Standard Deviation 5.40

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Enrolled participants who did not withdraw before 12-weeks and completed this questionnaire.

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.

Outcome measures

Measure	Brief Behavioral Activation n=57 Participants This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care n=61 Participants This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Change From Baseline in Quality of Life at 12 Weeks Total Score at Baseline	36.18 score on a scale Standard Deviation 15.43	34.02 score on a scale Standard Deviation 17.84
Change From Baseline in Quality of Life at 12 Weeks Total Score at Week 12	45.83 score on a scale Standard Deviation 19.53	36.68 score on a scale Standard Deviation 19.61

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Enrolled participants who did not withdraw prior to week 12 and completed this assessment measure at week 12.

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.

Outcome measures

Measure	Brief Behavioral Activation n=55 Participants This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care n=61 Participants This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Change From Baseline in Sleep Disturbances at 12 Weeks Total Score at Baseline	17.07 score on a scale Standard Deviation 7.18	16.48 score on a scale Standard Deviation 6.66
Change From Baseline in Sleep Disturbances at 12 Weeks Total Score at Week 12	15.95 score on a scale Standard Deviation 7.48	15.77 score on a scale Standard Deviation 6.74

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Enrolled participants who did not withdraw from the study and completed this assessment measure at week 12.

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.

Outcome measures

Measure	Brief Behavioral Activation n=54 Participants This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care n=58 Participants This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks Total Score at Baseline	21.91 score on a scale Standard Deviation 3.56	20.78 score on a scale Standard Deviation 4.01
Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks Total Score at Week 12	24.19 score on a scale Standard Deviation 3.93	21.17 score on a scale Standard Deviation 4.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 weeks

Population: Enrolled patients who did not withdraw from the study and completed this assessment at week 12.

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.

Outcome measures

Measure	Brief Behavioral Activation n=57 Participants This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is 4-session individual workshop using behavioral activation techniques.	Usual Care n=61 Participants This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks Total Score at Baseline	2.02 score on a scale Standard Deviation 4.27	1.69 score on a scale Standard Deviation 4.13
Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks Total Score at Week 12	1.19 score on a scale Standard Deviation 3.49	1.13 score on a scale Standard Deviation 4.18

Adverse Events

Brief Behavioral Activation

Serious events: 8 serious events

Other events: 12 other events

Deaths: 0 deaths

Usual Care

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Brief Behavioral Activation n=68 participants at risk This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is a 4-session individual workshop using behavioral activation techniques.	Usual Care n=72 participants at risk This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Injury, poisoning and procedural complications Hospitalization Due to Injury	5.9% 4/68 • Number of events 5 • 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.	2.8% 2/72 • Number of events 2 • 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.
Surgical and medical procedures Hospitalization due to	1.5% 1/68 • Number of events 2 • 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.	2.8% 2/72 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders Hospitalization due to Pneumonia	2.9% 2/68 • Number of events 2 • 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.	0.00% 0/72 • 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.
Psychiatric disorders Hospitalization due to Psychiatric Disorders	1.5% 1/68 • Number of events 1 • 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.	0.00% 0/72 • 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.

Other adverse events

Measure	Brief Behavioral Activation n=68 participants at risk This is a 4-session individual workshop using behavioral activation techniques, where content is delivered primarily in the first 2 sessions and 2 additional sessions are used as boosters. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Brief Behavioral Activation: This is a 4-session individual workshop using behavioral activation techniques.	Usual Care n=72 participants at risk This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Usual Care: Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Surgical and medical procedures Outpatient Surgery	1.5% 1/68 • Number of events 1 • 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.	1.4% 1/72 • Number of events 1 • 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.
Psychiatric disorders Clinically Significant Increase in Depressive Symptoms	5.9% 4/68 • Number of events 4 • 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.	1.4% 1/72 • Number of events 1 • 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.
Injury, poisoning and procedural complications Emergency Room Visit	8.8% 6/68 • Number of events 8 • 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.	1.4% 1/72 • Number of events 1 • 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.
Psychiatric disorders Distressed Participant Unrelated to Study	1.5% 1/68 • Number of events 1 • 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.	0.00% 0/72 • 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.

Additional Information

Dr. Jennifer Funderburk

VA Center for Integrated Healthcare

Phone: 315-425-4400

Email: Jennifer.Funderburk@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place