- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02276807
Improving Mood in Veterans in Primary Care
RCT of Behavioral Activation for Depression and Suicidality in Primary Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14215
- VA Western New York Healthcare System, Buffalo, NY
-
Canandaigua, New York, United States, 14424
- Canandaigua VA Medical Center, Canandaigua, NY
-
Syracuse, New York, United States, 13210
- Syracuse VA Medical Center, Syracuse, NY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Behavioral Activation
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.
|
This is a 4-session individual workshop using behavioral activation techniques.
|
Active Comparator: 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.
|
Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Depressive Symptoms at 12 Weeks
Time Frame: 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.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Quality of Life at 12 Weeks
Time Frame: 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.
|
Baseline and 12 weeks
|
Change From Baseline in Sleep Disturbances at 12 Weeks
Time Frame: 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.
|
Baseline and 12 weeks
|
Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
Time Frame: 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.
|
Baseline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks
Time Frame: 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.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer Schum Funderburk, PhD, Syracuse VA Medical Center, Syracuse, NY
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 14-047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Brief Behavioral Activation
-
University of Texas at AustinRecruiting
-
University of Mississippi Medical CenterTerminatedDepression | Asthma | UrticariaUnited States
-
University of North Carolina, Chapel HillCompleted
-
Dartmouth-Hitchcock Medical CenterRecruiting
-
Lovisenberg Diakonale HospitalOslo Metropolitan UniversityCompleted
-
Boston UniversityUnknown
-
Uppsala UniversityVästmanland County Council, SwedenTerminatedDepression | Depressive SymptomsSweden
-
Mount Sinai Hospital, CanadaHarvard Medical School (HMS and HSDM); Patient-Centered Outcomes Research Institute and other collaboratorsActive, not recruitingPerinatal DepressionUnited States, Canada
-
University of Wisconsin, MadisonCompleted
-
New York State Psychiatric InstituteCallen-Lorde Community Health CenterCompletedHIV Infection | FatigueUnited States