How Long Should a Behavioral Activation Single-session Intervention be? A Four-armed Trial Comparing Effectiveness by Intervention Duration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,145
- 试验地点
- 1
- 主要终点
- Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009)
研究概览
简要总结
In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness.
In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions.
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
- Double (Participant, Investigator)
盲法说明
Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. They will know that the study compares multiple interventions but will not know to which arm they have been assigned. Additionally, the measures will be self-administered, so there is no scope for evaluator bias. There will be no interaction between participants and investigators.
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
- •Participants must be:
- •Located in the United States
- •At least 18 years old
- •Patient Health Questionnaire-8 (PHQ-8) score of at least 10 (moderate or more severe) at screener.
- •Able to read and speak fluent English
- •Able to access to the internet via a computer, tablet or smartphone for the next eight weeks
排除标准
- •Participants who have completed the first session of the study before or completed another study testing a depression intervention from our laboratory via the same participant recruitment platform in the past two months.
研究组 & 干预措施
15-minute single-session depression intervention
This is the adult version of the Action Brings Change (ABC) Project.
干预措施: Action Brings Change Project (15-minute adult version) (Behavioral)
10-minute single-session depression intervention
This includes a shortened version of the ABC Project.
干预措施: Action Brings Change Project (10-minute adult version) (Behavioral)
6-minute single-session depression intervention
This includes a shortened version of the ABC Project.
干预措施: Action Brings Change Project (6-minute adult version) (Behavioral)
2-minute single-session depression intervention
This includes a shortened version of the ABC Project.
干预措施: Action Brings Change Project (2-minute adult version) (Behavioral)
结局指标
主要结局
Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009)
时间窗: Baseline to 8 weeks post-intervention
Patient Health Questionnaire-8 is a well-validated and self-administered measure to assess depression symptom severity in the general population. Participants are asked to rate how often they are bothered by 8 items (e.g., Poor appetite or overeating) on a scale of 0 (Not at all) to 3 (Nearly every day). Total score can range from 0 to 24, with higher scores indicating higher symptom severity.
次要结局
- Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013)(Baseline to 8 weeks post-intervention)
- Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004)(Baseline to 8 weeks post-intervention)
- Presence of an "Aha! moment" at post-intervention(Immediately post-intervention)
- Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016)(Baseline to 8 weeks post-intervention)
- Significance of the "Aha! moment" at 8 weeks post-intervention(8 weeks post-intervention)
- Intervention satisfaction star rating at 8 week follow-up(8 weeks post-intervention)
- Presence of an "Aha! moment" at 8 weeks post-intervention(8 weeks post-intervention)
- Significance of the "Aha! moment" at immediately post-intervention(Immediately post-intervention)
- Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004)(Immediately post-intervention)
- Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004)(8 weeks post-intervention)
- Intervention satisfaction star rating at post-intervention(Immediately post-intervention)
- Change in Beck Hopelessness Scale - 4-item at post-intervention(Baseline to immediately post-intervention)
研究者
Jessica Schleider
Professor
Northwestern University