Depression
Conditions
Keywords
Depression, Behavioral Symptoms, Mental Disorders, Depressive Disorder, suicidal ideation, primary health care, Veterans
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.
Detailed 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.
Interventions
BEHAVIORALBrief Behavioral Activation
This is a 4-session individual workshop using behavioral activation techniques.
OTHERUsual Care
Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depressive Symptoms at 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quality of Life at 12 Weeks | 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. |
| Change From Baseline in Sleep Disturbances at 12 Weeks | 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. |
| Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 a 4-session individual workshop using behavioral activation techniques. | 68 |
| 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. | 72 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 10 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | Brief Behavioral Activation | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 14.9 | 53.0 years STANDARD_DEVIATION 14.2 | 54.3 years STANDARD_DEVIATION 13.4 |
| Beck Scale for Suicidal Ideation (SSI) | 2.1 units on a scale STANDARD_DEVIATION 4.9 | 2.0 units on a scale STANDARD_DEVIATION 4.3 | 1.8 units on a scale STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 130 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire-9 (PHQ-9) | 16.0 units on a scale STANDARD_DEVIATION 4.3 | 16.0 units on a scale STANDARD_DEVIATION 4.4 | 15.9 units on a scale STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 43 Participants | 92 Participants | 49 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 62 Participants | 128 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 72 |
| other Total, other adverse events | 12 / 68 | 3 / 72 |
| serious Total, serious adverse events | 8 / 68 | 4 / 72 |
Outcome results
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.
Time frame: Baseline and 12 weeks
Population: Participants who did not withdraw before week 12 and completed this questionnaire at week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Activation | 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 |
| Brief Behavioral Activation | 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 |
| Usual Care | Change From Baseline in Depressive Symptoms at 12 Weeks | PHQ-9 Total Score at Baseline | 15.93 score on a scale | Standard Deviation 4.38 |
| Usual Care | Change From Baseline in Depressive Symptoms at 12 Weeks | PHQ-9 Total Score at Week 12 | 12.56 score on a scale | Standard Deviation 5.4 |
p-value: <0.05ANOVA
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.
Time frame: Baseline and 12 weeks
Population: Enrolled participants who did not withdraw before 12-weeks and completed this questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Activation | Change From Baseline in Quality of Life at 12 Weeks | Total Score at Baseline | 36.18 score on a scale | Standard Deviation 15.43 |
| Brief Behavioral Activation | 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 |
| Usual Care | Change From Baseline in Quality of Life at 12 Weeks | Total Score at Baseline | 34.02 score on a scale | Standard Deviation 17.84 |
| Usual Care | Change From Baseline in Quality of Life at 12 Weeks | Total Score at Week 12 | 36.68 score on a scale | Standard Deviation 19.61 |
p-value: <0.05ANOVA
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.
Time frame: Baseline and 12 weeks
Population: Enrolled participants who did not withdraw prior to week 12 and completed this assessment measure at week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Activation | Change From Baseline in Sleep Disturbances at 12 Weeks | Total Score at Baseline | 17.07 score on a scale | Standard Deviation 7.18 |
| Brief Behavioral Activation | Change From Baseline in Sleep Disturbances at 12 Weeks | Total Score at Week 12 | 15.95 score on a scale | Standard Deviation 7.48 |
| Usual Care | Change From Baseline in Sleep Disturbances at 12 Weeks | Total Score at Baseline | 16.48 score on a scale | Standard Deviation 6.66 |
| Usual Care | Change From Baseline in Sleep Disturbances at 12 Weeks | Total Score at Week 12 | 15.77 score on a scale | Standard Deviation 6.74 |
p-value: <0.05ANOVA
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.
Time frame: Baseline and 12 weeks
Population: Enrolled participants who did not withdraw from the study and completed this assessment measure at week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Activation | 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 |
| Brief Behavioral Activation | 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 |
| Usual Care | Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks | Total Score at Baseline | 20.78 score on a scale | Standard Deviation 4.01 |
| Usual Care | Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks | Total Score at Week 12 | 21.17 score on a scale | Standard Deviation 4.91 |
p-value: <0.05ANOVA
Other Pre-specified
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.
Time frame: Baseline and 12 weeks
Population: Enrolled patients who did not withdraw from the study and completed this assessment at week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Behavioral Activation | 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 |
| Brief Behavioral Activation | 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 |
| Usual Care | Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks | Total Score at Baseline | 1.69 score on a scale | Standard Deviation 4.13 |
| Usual Care | Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks | Total Score at Week 12 | 1.13 score on a scale | Standard Deviation 4.18 |
p-value: <0.05ANOVA