SSIs for Mental Health and Loneliness
Brief Internet Interventions to Support Mental Health
1 other identifier
interventional
4,370
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2022
CompletedStudy Start
First participant enrolled
December 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2023
CompletedJuly 22, 2024
July 1, 2024
9 months
November 29, 2022
July 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in UCLA Loneliness Scale Version 3 at 8 weeks
A 20-item measure of trait loneliness. Range 20-80 with higher scores indicated more severe loneliness. Included in studies 1, 3, and 4
Baseline, 8-week follow-up
Secondary Outcomes (19)
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
Change in 3-item Mini Social Phobia Inventory at 8 weeks
Baseline, 8-week follow-up
Change in 3-item Mini Social Phobia Inventory at 4 weeks
Baseline, 4-week follow-up
- +14 more secondary outcomes
Study Arms (11)
(Study 1) 3-week Loneliness Program
ACTIVE COMPARATORThe second and third sessions are completed in the second and third week, respectively, after beginning the study.
(Study 1) Single-session loneliness program
EXPERIMENTAL(Study 1) Single-session active control program
ACTIVE COMPARATOR(Study 2) Popular online content-based single-session intervention for distress
EXPERIMENTAL(Study 2) Researcher-created single-session intervention for distress
ACTIVE COMPARATOR(Study 2) Online help-seeking as usual
ACTIVE COMPARATOR(Study 3) Popular online content-based single-session intervention for loneliness
EXPERIMENTAL(Study 3) Researcher-created single-session intervention for loneliness
ACTIVE COMPARATOR(Study 3) Single-session active control program
ACTIVE COMPARATOR(Study 4) 23-minute loneliness program
ACTIVE COMPARATOR(Study 4) 8-minute loneliness program
EXPERIMENTALInterventions
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.
The Overcoming Loneliness Three-Week Intervention condensed into a single-session intervention lasting 20-30 minutes.
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
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Jacobs Foundationcollaborator
Study Sites (1)
Online (based at UC Irvine)
Irvine, California, 92697, United States
Related Publications (9)
Cacioppo JT, Cacioppo S. The growing problem of loneliness. Lancet. 2018 Feb 3;391(10119):426. doi: 10.1016/S0140-6736(18)30142-9. No abstract available.
PMID: 29407030BACKGROUNDHickin N, Kall A, Shafran R, Sutcliffe S, Manzotti G, Langan D. The effectiveness of psychological interventions for loneliness: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Aug;88:102066. doi: 10.1016/j.cpr.2021.102066. Epub 2021 Jul 18.
PMID: 34339939BACKGROUNDMasi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
PMID: 20716644BACKGROUNDKall A, Backlund U, Shafran R, Andersson G. Lonesome no more? A two-year follow-up of internet-administered cognitive behavioral therapy for loneliness. Internet Interv. 2020 Jan 17;19:100301. doi: 10.1016/j.invent.2019.100301. eCollection 2020 Mar.
PMID: 32071885BACKGROUNDYamaguchi S, Ojio Y, Ando S, Bernick P, Ohta K, Watanabe KI, Thornicroft G, Shiozawa T, Koike S. Long-term effects of filmed social contact or internet-based self-study on mental health-related stigma: a 2-year follow-up of a randomised controlled trial. Soc Psychiatry Psychiatr Epidemiol. 2019 Jan;54(1):33-42. doi: 10.1007/s00127-018-1609-8. Epub 2018 Oct 12.
PMID: 30315333BACKGROUNDRizvi SL, Finkelstein J, Wacha-Montes A, Yeager AL, Ruork AK, Yin Q, Kellerman J, Kim JS, Stern M, Oshin LA, Kleiman EM. Randomized clinical trial of a brief, scalable intervention for mental health sequelae in college students during the COVID-19 pandemic. Behav Res Ther. 2022 Feb;149:104015. doi: 10.1016/j.brat.2021.104015. Epub 2021 Dec 21.
PMID: 34958980BACKGROUNDMurphy ST, Frank LB, Chatterjee JS, Baezconde-Garbanati L. Narrative versus Non-narrative: The Role of Identification, Transportation and Emotion in Reducing Health Disparities. J Commun. 2013 Feb;63(1):10.1111/jcom.12007. doi: 10.1111/jcom.12007.
PMID: 24347679BACKGROUNDKroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
PMID: 19996233BACKGROUNDKaveladze BT, Gastelum SF, Ngo DC, Delacruz P, Cohen KA, Kall A, Andersson G, Schleider JL, Schueller SM. A randomized controlled trial comparing brief online self-guided interventions for loneliness. J Consult Clin Psychol. 2025 Jan;93(1):54-63. doi: 10.1037/ccp0000908. Epub 2024 Sep 26.
PMID: 39325409DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen M Schueller, Ph.D.
University of California, Irvine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 29, 2022
First Posted
January 18, 2023
Study Start
December 4, 2022
Primary Completion
September 6, 2023
Study Completion
September 6, 2023
Last Updated
July 22, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The data will be available as soon as it is cleaned and de-identified and it will remain publicly available as long as possible.
- Access Criteria
- The data will be available to the public via an online dataset on the Open Science Framework (osf.io)
De-identified participant data will be shared, including all measures. Participants' responses to open text response questions within the program will not be shared for the sake of privacy.