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Improving Mood in Veterans in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276807
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : June 14, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Brief Behavioral Activation Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT of Behavioral Activation for Depression and Suicidality in Primary Care
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


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.
Behavioral: Brief Behavioral Activation
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.
Other: Usual Care
Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
Other Name: Usual Care condition




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276807


Locations
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United States, New York
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, United States, 14424
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jennifer Schum Funderburk, PhD Syracuse VA Medical Center, Syracuse, NY
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02276807    
Other Study ID Numbers: IIR 14-047
First Posted: October 28, 2014    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Depression
Behavioral Symptoms
Mental Disorders
Depressive Disorder
suicidal ideation
primary health care
Veterans
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders