Clinical trial NCT05687162: SSIs for Mental Health and Loneliness
Official title: Brief Internet Interventions to Support Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Mental Health Issue
Distress, Emotional
Depression
Anxiety
Stress
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Jacobs Foundation
First posted: 2023-01-18
Enrollment: 4370
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In each study, participants will be randomly assigned to complete one of three online programs, assessing DVs at baseline and 4 and 8 weeks later.

Note that studies 1-3 have 3 arms, and study 4 has 2 arms, so in total 11 arms are included in this project.
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in UCLA Loneliness Scale Version 3 at 8 weeks
timeFrame: Baseline, 8-week follow-up
Secondary outcomes:
measure: Change in UCLA Loneliness Scale Version 3 at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Change in Depression Anxiety and Stress Scale - 9-item total score at 8 weeks
timeFrame: Baseline, 8-week follow-up
measure: Change in Depression Anxiety and Stress Scale - 9-item total score at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Change in 3-item Mini Social Phobia Inventory at 8 weeks
timeFrame: Baseline, 8-week follow-up
measure: Change in 3-item Mini Social Phobia Inventory at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Change in Short form of the General Self-Efficacy Scale at 8 weeks
timeFrame: Baseline, 8-week follow-up
measure: Change in Short form of the General Self-Efficacy Scale at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Change in Short form of the General Self-Efficacy Scale immediately post-intervention
timeFrame: 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)
measure: Change in Beck Hopelessness Scale - 4-item at 8 weeks
timeFrame: Baseline, 8-week follow-up
measure: Change in Beck Hopelessness Scale - 4-item at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Change in Beck Hopelessness Scale - 4-item immediately post-intervention
timeFrame: 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)
measure: Change in Frequency of actions and thoughts scale at 8 weeks
timeFrame: Baseline, 8-week follow-up
measure: Change in Frequency of actions and thoughts scale at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Program Feedback Scale
timeFrame: 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)
measure: Credibility and Expectancy Questionnaire
timeFrame: 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)
measure: Insight experience
timeFrame: 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)
measure: Star rating
timeFrame: 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)
measure: Change in PROMIS Meaning and Purpose in Life - 4-item at 4 weeks
timeFrame: Baseline, 4-week follow-up
measure: Change in PROMIS Meaning and Purpose in Life - 4-item at 8 weeks
timeFrame: Baseline, 8-week follow-up
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Online (based at UC Irvine)
state: California
Study officials:
affiliation: University of California, Irvine
name: Stephen M Schueller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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