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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Behavioral Activation | Experimental | This 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 Comparator | This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Activation | Behavioral | This is a 4-session individual workshop using behavioral activation techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
Inclusion Criteria:
Veterans:
Exclusion Criteria:
Veterans who are:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Schum Funderburk, PhD | Syracuse VA Medical Center, Syracuse, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215 | United States | ||
| Canandaigua VA Medical Center, Canandaigua, NY |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33516082 | Derived | 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. |
| Label | URL |
|---|---|
| The co-PI's are affiliated with the VA Center for Integrated Healthcare and this website describes current and past research projects similar to the one in this study. | View source |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who did not withdraw before week 12 and completed this questionnaire at week 12 | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization Due to Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Outpatient Surgery | Surgical and medical procedures | Systematic Assessment |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Funderburk | VA Center for Integrated Healthcare | 315-425-4400 | 54703 | Jennifer.Funderburk@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2019 | Mar 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| Usual Care | Other | 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 |
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. |
| Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| Canandaigua |
| New York |
| 14424 |
| United States |
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210 | United States |
| Click here for more information about this study: RCT of Behavioral Activation for Depression and Suicidality in Primary Care | View source |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Patient Health Questionnaire-9 (PHQ-9) | The minimum value is 0 and the maximum value is 27. Higher scores mean a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Beck Scale for Suicidal Ideation (SSI) | This is focused on the past week's suicidal ideation. The minimum score is 0 and the maximum score is 38. Higher scores mean worse suicidal ideation. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| 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. | Enrolled participants who did not withdraw before 12-weeks and completed this questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| 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. | Enrolled participants who did not withdraw prior to week 12 and completed this assessment measure at week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| 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. | Enrolled participants who did not withdraw from the study and completed this assessment measure at week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
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|
|
| 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. | Enrolled patients who did not withdraw from the study and completed this assessment at week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| 0 |
| 68 |
| 8 |
| 68 |
| 12 |
| 68 |
| EG001 | 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. | 0 | 72 | 4 | 72 | 3 | 72 |
| Hospitalization due to | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization due to Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization due to Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
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| Clinically Significant Increase in Depressive Symptoms | Psychiatric disorders | Systematic Assessment | Greater than 9 point increase on total score on the PHQ-9 |
|
| Emergency Room Visit | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Distressed Participant Unrelated to Study | Psychiatric disorders | Systematic Assessment |
|
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