RCT of Behavioral Activation for Depression and Suicidality in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Change From Baseline in Depressive Symptoms at 12 Weeks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Brief Behavioral Activation (Behavioral)
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.
干预措施: Usual Care (Other)
结局指标
主要结局
Change From Baseline in Depressive Symptoms at 12 Weeks
时间窗: 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.
次要结局
- Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks(Baseline and 12 weeks)
- Change From Baseline in Quality of Life at 12 Weeks(Baseline and 12 weeks)
- Change From Baseline in Sleep Disturbances at 12 Weeks(Baseline and 12 weeks)