Brief Internet Interventions to Support Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,370
- 试验地点
- 2
- 主要终点
- Change in UCLA Loneliness Scale Version 3 at 8 weeks
研究概览
简要总结
This project includes three studies that explore the effectiveness of brief internet interventions for mental health and loneliness.
Study 1: The goal of this clinical trial is to examine if a brief online single-session intervention (SSI) adapted from an evidence-based internet cognitive behavioral therapy can reduce feelings of loneliness in people aged 16 and older who struggle with loneliness. The main question it aims to answer is if a brief SSI is sufficient to meaningfully reduce loneliness compared to an active control. Researchers will test these questions by comparing change in loneliness after 8 weeks between participants randomly assigned to either 1) a 30-minute online SSI for loneliness or 2) a 3-session online intervention for loneliness or 3) an active control SSI.
Study 2: The goal of this clinical trial is to examine if an SSI for psychological distress that uses popular online content as its primary form of intervention content can reduce feelings of psychological distress in people aged 16 and older who struggle with psychological distress. The main questions it aims to answer are 1) if curated popular online content can be more effective in supporting people struggling with psychological distress than researcher-created content and 2) if curated popular online content can be more effective in supporting people struggling with psychological distress than un-curated self-selected popular online content. Researchers will test these questions by comparing change in distress after 8 weeks between participants randomly assigned to either 1) 25-minute popular online content-based SSI for distress or 2) an effective 25-minute online SSI for distress with evidence-based researcher-created content or 3) online help-seeking as usual.
Study 3: The goal of this clinical trial is to examine if an SSI for loneliness that uses popular online content as its primary form of intervention content can reduce feelings of loneliness in people aged 16 and older who struggle with loneliness. The main questions it aims to answer are 1) if curated popular online content can be more effective in supporting people struggling with loneliness than researcher-created content, 2) if curated popular online content can be more effective in supporting people struggling with psychological distress than an active control, and 3) replicating the comparison in study 1, if a brief SSI is sufficient to meaningfully reduce loneliness compared to an active control. The study will test these questions by comparing change in loneliness after 8 weeks between participants randomly assigned to either 1) a 25-minute popular online content-based SSI for loneliness or 2) a 25-minute online SSI for loneliness with evidence-based researcher-created content or 3) an active control SSI.
Study 4: This experiment compared the loneliness SSI from study 1 to a version of it that lasted about half as long. It used a two-group repeated-measures experimental design, examining between-subjects differences in loneliness between baseline and eight-week follow-up between conditions.
详细描述
Study 1: Severe loneliness is globally prevalent and is strongly associated with impaired mental and physical well-being, making it a significant public health issue. Evidence-based interventions for loneliness reach a small subset of people who might benefit from them, so identifying new strategies for addressing loneliness at scale should be a high priority. Online single-session interventions (SSIs) have demonstrated particular promise to offer efficient and highly-scalable support to diverse populations.
The study will test if an internet-mediated self-guided SSI can produce lasting improvements in loneliness. The investigators adapted a 9-week online loneliness intervention into a 3-week 3-session version and a single-session 30-minute SSI version. The investigators will randomly assign participants to complete the 3-week version, the SSI version, or a control SSI.
The investigators will collect self-report measures at baseline, directly after the intervention, and 4 and 8 weeks after baseline. The investigators will also measure participant engagement with the intervention using self-report and behavioral measures. The investigators will recruit teens and adults (16+) for the study via social media.
Study 2: SSIs for mental health have shown promise for delivering efficient support to diverse populations. Despite their brevity, existing SSIs still struggle to engage users.
This study will explore using a broad range of mental health-relevant popular online content (eg, psychology lectures on YouTube, Instagram posts from self-care influencers, and blog posts written by people who struggle with mood disorders) in SSIs. Although it is often not evidence-based, popular online content may be more appealing and tailored to particular audiences than the researcher-created intervention content typically used in evidence-based SSIs.
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 not be informed which condition they were assigned to or what the other conditions involve. The investigators will not interact with participants or see which condition they are in during the intervention.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be fluent in English
- •Be 16 years old + (participants in studies 2-4 recruited on CloudResearch Connect had to be at least 18)
- •Have internet access and a computer, smartphone, or tablet
- •To be compensated for participation and be included in the main analysis, participants in studies 1 and 2 must meet criteria for "struggling with loneliness" (ie, a score on the 3-item loneliness screen of at least 6, and indicating that one's loneliness is causing one distress). Otherwise, participants can still participate in the study on a volunteer basis.
- •To be compensated for participation and be included in the main analysis, participants in study 3 must meet criteria for "struggling with distress" (ie, a score on either the depression or anxiety subscale greater than or equal to 3 (range 0-6), as these scores are suggestive of a depressive or anxiety disorder.
排除标准
- •Having completed the study in the past
- •Failing both of the attention checks in the baseline measures.
- •Spending less than 3 minutes completing the study introduction and baseline measures (ie, were very likely bots)
- •Indicating, at the end of the study, that one did not complete the study seriously and that one's data should not be included in analyses.
结局指标
主要结局
Change in UCLA Loneliness Scale Version 3 at 8 weeks
时间窗: Baseline, 8-week follow-up
A 20-item measure of trait loneliness. Range 20-80 with higher scores indicated more severe loneliness. Included in studies 1, 3, and 4
次要结局
- Change in 3-item Mini Social Phobia Inventory at 8 weeks(Baseline, 8-week follow-up)
- Insight experience(immediately post-intervention (roughly 30 minutes after beginning study for single-session conditions, and roughly 2 weeks after beginning study for 3-week iCBT condition))
- Change in PROMIS Meaning and Purpose in Life - 4-item at 4 weeks(Baseline, 4-week follow-up)
- Change in 3-item Mini Social Phobia Inventory at 4 weeks(Baseline, 4-week follow-up)
- Change in Short form of the General Self-Efficacy Scale at 8 weeks(Baseline, 8-week follow-up)
- Change in Beck Hopelessness Scale - 4-item at 8 weeks(Baseline, 8-week follow-up)
- Change in Beck Hopelessness Scale - 4-item at 4 weeks(Baseline, 4-week follow-up)
- Credibility and Expectancy Questionnaire(immediately post-intervention (roughly 30 minutes after beginning study for single-session conditions, and roughly 2 weeks after beginning study for 3-week iCBT condition))
- Change in PROMIS Meaning and Purpose in Life - 4-item at 8 weeks(Baseline, 8-week follow-up)
- Change in Short form of the General Self-Efficacy Scale at 4 weeks(Baseline, 4-week follow-up)
- Change in Short form of the General Self-Efficacy Scale immediately post-intervention(Baseline, immediately post-intervention (roughly 30 minutes after beginning study for single-session conditions, and roughly 2 weeks after beginning study for 3-week iCBT condition))
- Change in Beck Hopelessness Scale - 4-item immediately post-intervention(Baseline, immediately post-intervention (roughly 30 minutes after beginning study for single-session conditions, and roughly 2 weeks after beginning study for 3-week iCBT condition))
- Change in Frequency of actions and thoughts scale at 4 weeks(Baseline, 4-week follow-up)
- Program Feedback Scale(immediately post-intervention (roughly 30 minutes after beginning study for single-session conditions, and roughly 2 weeks after beginning study for 3-week iCBT condition))
- Change in Frequency of actions and thoughts scale at 8 weeks(Baseline, 8-week follow-up)
- Star rating(immediately post-intervention (roughly 30 minutes after beginning study for single-session conditions, and roughly 2 weeks after beginning study for 3-week iCBT condition))
- Change in UCLA Loneliness Scale Version 3 at 4 weeks(Baseline, 4-week follow-up)
- Change in Depression Anxiety and Stress Scale - 9-item total score at 8 weeks(Baseline, 8-week follow-up)
- Change in Depression Anxiety and Stress Scale - 9-item total score at 4 weeks(Baseline, 4-week follow-up)
研究者
Stephen Matthew Schueller
Associate Professor
University of California, Irvine