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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Buffalo、New York、アメリカ、14215
- VA Western New York Healthcare System, Buffalo, NY
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Canandaigua、New York、アメリカ、14424
- Canandaigua VA Medical Center, Canandaigua, NY
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Syracuse、New York、アメリカ、13210
- Syracuse VA Medical Center, Syracuse, NY
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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This is a 4-session individual workshop using behavioral activation techniques.
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アクティブコンパレータ：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.
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Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Depressive Symptoms at 12 Weeks
時間枠：Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Quality of Life at 12 Weeks
時間枠：Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Change From Baseline in Sleep Disturbances at 12 Weeks
時間枠：Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
時間枠：Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks
時間枠：Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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協力者と研究者
捜査官
- 主任研究者：Jennifer Schum Funderburk, PhD、Syracuse VA Medical Center, Syracuse, NY
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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