NCT05687162

SSIs for Mental Health and Loneliness

Brief Internet Interventions to Support Mental Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,370 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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)

Conditions

• Loneliness
• Mental Health Issue
• Distress, Emotional
• Depression
• Anxiety
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Overcoming Loneliness three-week intervention	A self-guided online loneliness intervention with three 10-20 minute sessions. The intervention content draws heavily from Internet Cognitive Behavioral Therapy for Loneliness and follows the form of single-session mental health interventions.
BEHAVIORAL	Overcoming Loneliness single-session intervention	The Overcoming Loneliness Three-Week Intervention condensed into a single-session intervention lasting 20-30 minutes.
BEHAVIORAL	Single-session "Sharing Feelings" program	A self-guided online supportive therapy intervention with a single 20-30 minute session intended to encourage users to share feelings with close others. Slightly modified from the "Sharing Feelings" intervention
BEHAVIORAL	The Blu Surfer program: a popular online content-based intervention for psychological distress	The Blu Surfer Program is a 25-minute SSI the research team developed centered on popular online content relevant to mental health. In the SSI, the user is first asked to select the kinds of support they would like to view. Next, the user is asked to explore a library of annotated popular online content (filtered by their desired kinds of content) and to select the content they find personally valuable. Finally, the SSI provides the user an annotated list of the content they selected. Users can keep this list to draw from, build on, or share later on as they wish.
BEHAVIORAL	The Action Brings Change (ABC) Program (TEAM Lab version)	The ABC project is a 20-30-minute SSI for teens based on behavioral activation. It was found to be efficacious for reducing depression, anxiety, hopelessness, and self-hate and increasing perceived control and agency in youth (link to SSI: https://osf.io/ch2tg/, license: http://creativecommons.org/licenses/by-nc-sa/4.0/). The researchers modified the phrasing in the intervention to make it more relevant to both teens and adults, as the original was designed for only teens.
BEHAVIORAL	Online help-seeking as usual	This intervention, created by the present research team, aims to emulate how one might find support on their own using the internet. In this condition, participants are asked to browse the internet for 25 minutes to find popular online content relevant to their personal struggles and create an annotated list of links to the content they find useful. The intervention is similar to a "self-study" condition, which found self-study and a video intervention equally increased mental health knowledge. The survey platform provides text entry boxes to help each participant create their guide and then provides a text version of their guide for them to keep.
BEHAVIORAL	The Lonely Blu Surfer program: a popular online content-based intervention for loneliness	The Lonely Blu Surfer Program is a 25-minute SSI the research team developed centered on popular online content relevant to loneliness. In the SSI, the user is first asked to select the kinds of support they would like to view. Next, the user is asked to explore a library of annotated popular online content (filtered by their desired kinds of content) and to select the content they find personally valuable. Finally, the SSI provides the user an annotated list of the content they selected. Users can keep this list to draw from, build on, or share later on as they wish.
BEHAVIORAL	Overcoming loneliness SSI 8-minute version	A shortened version of an online self-guided intervention based on principles of CBT for loneliness. The research team created this intervention by cutting lengthy didactic material and exercises from the 23-minute version, while maintaining its core concepts.

Timeline

• Start date: 2022-12-04
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2023-01-18
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States