SSIs for Mental Health and Loneliness
- Conditions
- LonelinessMental Health IssueAnxietyDistress, EmotionalStressDepression
- Interventions
- Behavioral: Overcoming Loneliness single-session interventionBehavioral: Single-session "Sharing Feelings" programBehavioral: Overcoming Loneliness three-week interventionBehavioral: The Action Brings Change (ABC) Program (TEAM Lab version)Behavioral: Online help-seeking as usualBehavioral: Overcoming loneliness SSI 8-minute version
- Registration Number
- NCT05687162
- Lead Sponsor
- University of California, Irvine
- Brief Summary
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.
- Detailed Description
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.
In this study, researchers will examine the effectiveness of this content for addressing psychological distress. Researchers will conduct an experiment to compare a popular online content-based SSI to one that has already demonstrated efficacy and to online help seeking as usual to identify whether such content is useful within an SSI context. Researchers will measure change in psychological distress from baseline to 4-week and 8-week follow-ups.
Study 3: In this study, researchers aim to replicate and extend studies 1 and 2 to further evaluate the potential of an SSI for loneliness and the utility of popular online content as a mental health intervention.
In this study, researchers will examine the effectiveness of popular online content for addressing loneliness. Researchers will conduct an experiment to compare a popular online content-based SSI for loneliness to another online SSI for loneliness with researcher-created content and to an active control SSI. Researchers will measure change in loneliness from baseline to 4-week and 8-week follow-ups.
Study 4: This experiment tested whether a 10-minute SSI for loneliness would be less effective than a 20-minute SSI conveying the same general information. Moreover, the research team was interested in whether users would find the 10-minute version more acceptable and engaging. The research team used a two-group repeated-measures experimental design, examining between-subjects differences in change in DVs across time between conditions.This experiment was prospectively pre-registered on the Open Science Framework (https://osf.io/8bth2)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4370
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (Study 1) Single-session loneliness program Overcoming Loneliness single-session intervention - (Study 1) Single-session active control program Single-session "Sharing Feelings" program - (Study 3) Researcher-created single-session intervention for loneliness Overcoming Loneliness single-session intervention - (Study 3) Single-session active control program Single-session "Sharing Feelings" program - (Study 1) 3-week Loneliness Program Overcoming Loneliness three-week intervention The second and third sessions are completed in the second and third week, respectively, after beginning the study. (Study 2) Researcher-created single-session intervention for distress The Action Brings Change (ABC) Program (TEAM Lab version) - (Study 4) 23-minute loneliness program Overcoming Loneliness single-session intervention - (Study 2) Online help-seeking as usual Online help-seeking as usual - (Study 4) 8-minute loneliness program Overcoming loneliness SSI 8-minute version -
- Primary Outcome Measures
Name Time Method Change in UCLA Loneliness Scale Version 3 at 8 weeks 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
- Secondary Outcome Measures
Name Time Method Change in 3-item Mini Social Phobia Inventory at 8 weeks Baseline, 8-week follow-up A brief measure of social anxiety. Range 0-12 with higher scores indicating greater symptom severity. Included in studies 1 and 3
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) A 1-item measure of whether one experienced an insight moment as a result of the program. Range 0-1 with 1 indicating presence of an insight experience and 0 indicating a lack of insight experience. Included in all studies.
Change in PROMIS Meaning and Purpose in Life - 4-item at 4 weeks Baseline, 4-week follow-up a 4-item measure of meaning and purpose in life. Range 4-20 with higher scores indicating a greater sense of meaning and purpose. Included in studies 2 and 3.
Change in 3-item Mini Social Phobia Inventory at 4 weeks Baseline, 4-week follow-up A brief measure of social anxiety. Range 0-12 with higher scores indicating greater symptom severity. Included in studies 1 and 3
Change in Short form of the General Self-Efficacy Scale at 8 weeks Baseline, 8-week follow-up A 6-item measure of general self-efficacy. Range 6-24 with higher scores indicating greater self-efficacy. Included in studies 1-3
Change in Beck Hopelessness Scale - 4-item at 8 weeks Baseline, 8-week follow-up A brief version of a hopelessness measure. Range 4-12 with higher scores indicating more hopelessness. Included in all studies.
Change in Beck Hopelessness Scale - 4-item at 4 weeks Baseline, 4-week follow-up A brief version of a hopelessness measure. Range 4-12 with higher scores indicating more hopelessness. Included in studies 1-3.
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) A 6-item measure of user-perceived intervention appeal and efficacy. Range 6-54 with higher scores indicating higher user-perceived intervention appeal and efficacy. Included in all studies.
Change in PROMIS Meaning and Purpose in Life - 4-item at 8 weeks Baseline, 8-week follow-up a 4-item measure of meaning and purpose in life. Range 4-20 with higher scores indicating a greater sense of meaning and purpose. Included in studies 2 and 3.
Change in Short form of the General Self-Efficacy Scale at 4 weeks Baseline, 4-week follow-up A 6-item measure of general self-efficacy. Range 6-24 with higher scores indicating greater self-efficacy. Included in studies 1-3
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) A 6-item measure of general self-efficacy. Range 6-24 with higher scores indicating greater self-efficacy. Included in studies 1-3.
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) A brief version of a hopelessness measure. Range 4-12 with higher scores indicating greater hopelessness. Included in all studies.
Change in Frequency of actions and thoughts scale at 4 weeks Baseline, 4-week follow-up A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of cognitive behavioral therapy. Range 0-48 with higher scores indicating greater frequency of adaptive thoughts and behaviors. Included in studies 1-3.
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) A 7-item measure of engagement with and acceptability of SSIs. Range 7-35 with higher scores indicating greater engagement with and acceptability of the SSI. Included in all studies.
Change in Frequency of actions and thoughts scale at 8 weeks Baseline, 8-week follow-up A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of cognitive behavioral therapy. Range 0-48 with higher scores indicating greater frequency of adaptive thoughts and behaviors. Included in all studies.
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) A rating of program quality, from 1-5 stars with more stars indicating greater quality. Included in all studies.
Change in UCLA Loneliness Scale Version 3 at 4 weeks Baseline, 4-week follow-up A 20-item measure of trait loneliness. Range 20-80 with higher scores indicated more severe loneliness. Included in studies 1 and 3
Change in Depression Anxiety and Stress Scale - 9-item total score at 8 weeks Baseline, 8-week follow-up A brief scale with subscales measuring depression, anxiety, and stress. Range 0-27 with higher scores indicating greater symptom severity. Included in all studies.
Change in Depression Anxiety and Stress Scale - 9-item total score at 4 weeks Baseline, 4-week follow-up A brief scale with subscales measuring depression, anxiety, and stress. Range 0-27 with higher scores indicating greater symptom severity. Included in studies 1-3.
Trial Locations
- Locations (1)
Online (based at UC Irvine)
🇺🇸Irvine, California, United States