LonelinessNCT05687162
SSIs for Mental Health and Loneliness
A study testing Overcoming Loneliness three-week intervention, Overcoming Loneliness single-session intervention and Single-session "Sharing Feelings" program in people with Loneliness and Mental Health Issue, run by University of California, Irvine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Mental Health Issue, Distress, Emotional
- What is being tested?
- Overcoming Loneliness three-week intervention, Overcoming Loneliness single-session intervention and Single-session "Sharing Feelings" program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,370 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2022to 6 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Online (based at UC Irvine)
Irvine, California, 92697
About this study
Official title: Brief Internet Interventions to Support Mental Health
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.
Read more
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.
Read the 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
- Being tested
- Overcoming Loneliness three-week intervention, Overcoming Loneliness single-session intervention, Single-session "Sharing Feelings" program, The Blu Surfer program: a popular online content-based intervention for psychological distress, The Action Brings Change (ABC) Program (TEAM Lab version)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overcoming Loneliness three-week interventionBehavioural
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.
Overcoming Loneliness single-session interventionBehavioural
The Overcoming Loneliness Three-Week Intervention condensed into a single-session intervention lasting 20-30 minutes.
Single-session "Sharing Feelings" programBehavioural
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: a popular online content-based intervention for psychological distressBehavioural
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 Action Brings Change (ABC) Program (TEAM Lab version)Behavioural
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.
Online help-seeking as usualBehavioural
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: a popular online content-based intervention for lonelinessBehavioural
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.
Overcoming loneliness SSI 8-minute versionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| (Study 1) 3-week Loneliness Program | Active comparator | The second and third sessions are completed in the second and third week, respectively, after beginning the study. Receives: Behavioral: Overcoming Loneliness three-week intervention |
| (Study 1) Single-session loneliness program | Experimental | Not described Receives: Behavioral: Overcoming Loneliness single-session intervention |
| (Study 1) Single-session active control program | Active comparator | Not described Receives: Behavioral: Single-session "Sharing Feelings" program |
| (Study 2) Popular online content-based single-session intervention for distress | Experimental | Not described Receives: Behavioral: The Blu Surfer program: a popular online content-based intervention for psychological distress |
| (Study 2) Researcher-created single-session intervention for distress | Active comparator | Not described Receives: Behavioral: The Action Brings Change (ABC) Program (TEAM Lab version) |
| (Study 2) Online help-seeking as usual | Active comparator | Not described Receives: Behavioral: Online help-seeking as usual |
| (Study 3) Popular online content-based single-session intervention for loneliness | Experimental | Not described Receives: Behavioral: The Lonely Blu Surfer program: a popular online content-based intervention for loneliness |
| (Study 3) Researcher-created single-session intervention for loneliness | Active comparator | Not described Receives: Behavioral: Overcoming Loneliness single-session intervention |
| (Study 3) Single-session active control program | Active comparator | Not described Receives: Behavioral: Single-session "Sharing Feelings" program |
| (Study 4) 23-minute loneliness program | Active comparator | Not described Receives: Behavioral: Overcoming Loneliness single-session intervention |
| (Study 4) 8-minute loneliness program | Experimental | Not described Receives: Behavioral: Overcoming loneliness SSI 8-minute version |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 8-week follow-up
Secondary outcomes (19)
Change in UCLA Loneliness Scale Version 3 at 4 weeks
A 20-item measure of trait loneliness. Range 20-80 with higher scores indicated more severe loneliness. Included in studies 1 and 3
Measured: Baseline, 4-week follow-up
Change in Depression Anxiety and Stress Scale - 9-item total score at 8 weeks
A brief scale with subscales measuring depression, anxiety, and stress. Range 0-27 with higher scores indicating greater symptom severity. Included in all studies.
Measured: Baseline, 8-week follow-up
Change in Depression Anxiety and Stress Scale - 9-item total score at 4 weeks
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.
Measured: Baseline, 4-week follow-up
Change in 3-item Mini Social Phobia Inventory at 8 weeks
A brief measure of social anxiety. Range 0-12 with higher scores indicating greater symptom severity. Included in studies 1 and 3
Measured: Baseline, 8-week follow-up
Change in 3-item Mini Social Phobia Inventory at 4 weeks
A brief measure of social anxiety. Range 0-12 with higher scores indicating greater symptom severity. Included in studies 1 and 3
Measured: Baseline, 4-week follow-up
Change in Short form of the General Self-Efficacy Scale at 8 weeks
A 6-item measure of general self-efficacy. Range 6-24 with higher scores indicating greater self-efficacy. Included in studies 1-3
Measured: Baseline, 8-week follow-up
Change in Short form of the General Self-Efficacy Scale at 4 weeks
A 6-item measure of general self-efficacy. Range 6-24 with higher scores indicating greater self-efficacy. Included in studies 1-3
Measured: Baseline, 4-week follow-up
Change in Short form of the General Self-Efficacy Scale immediately post-intervention
A 6-item measure of general self-efficacy. Range 6-24 with higher scores indicating greater self-efficacy. Included in studies 1-3.
Measured: 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 at 8 weeks
A brief version of a hopelessness measure. Range 4-12 with higher scores indicating more hopelessness. Included in all studies.
Measured: Baseline, 8-week follow-up
Change in Beck Hopelessness Scale - 4-item at 4 weeks
A brief version of a hopelessness measure. Range 4-12 with higher scores indicating more hopelessness. Included in studies 1-3.
Measured: Baseline, 4-week follow-up
Change in Beck Hopelessness Scale - 4-item immediately post-intervention
A brief version of a hopelessness measure. Range 4-12 with higher scores indicating greater hopelessness. Included in all studies.
Measured: 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 8 weeks
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.
Measured: Baseline, 8-week follow-up
Change in Frequency of actions and thoughts scale at 4 weeks
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.
Measured: Baseline, 4-week follow-up
Program Feedback Scale
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.
Measured: 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)
Credibility and Expectancy Questionnaire
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.
Measured: 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)
Insight experience
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.
Measured: 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)
Star rating
A rating of program quality, from 1-5 stars with more stars indicating greater quality. Included in all studies.
Measured: 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
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.
Measured: Baseline, 4-week follow-up
Change in PROMIS Meaning and Purpose in Life - 4-item at 8 weeks
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.
Measured: Baseline, 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start4 Dec 2022
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Jacobs Foundation
- Responsible party
- Principal investigator, Stephen Matthew Schueller, University of California, Irvine
- Investigators
- Stephen M Schueller, Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687162
- Sponsor's protocol ID
- 1253
- Status last verified
- Jul 2024
- First submitted
- 29 Nov 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29407030Hickin 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.
PubMed 34339939Masi 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.
PubMed 20716644Kall 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.
PubMed 32071885Yamaguchi 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.
PubMed 30315333Rizvi 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.
PubMed 34958980Murphy 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.
PubMed 24347679Kroenke 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.
PubMed 19996233Kaveladze 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.
PubMed 39325409
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Internet Interventions to Support Mental Health
- ClinicalTrials.gov ID
- NCT05687162
- Acronym / sponsor ID
- 1253
- Conditions
- Loneliness, Mental Health Issue, Distress, Emotional, Depression, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,370 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Jacobs Foundation
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
- 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.
| Arm | Type | Receives |
|---|---|---|
| (Study 1) 3-week Loneliness Program | Active comparator | Behavioral: Overcoming Loneliness three-week interventionThe second and third sessions are completed in the second and third week, respectively, after beginning the study. |
| (Study 1) Single-session loneliness program | Experimental | Behavioral: Overcoming Loneliness single-session intervention |
| (Study 1) Single-session active control program | Active comparator | Behavioral: Single-session "Sharing Feelings" program |
| (Study 2) Popular online content-based single-session intervention for distress | Experimental | Behavioral: The Blu Surfer program: a popular online content-based intervention for psychological distress |
| (Study 2) Researcher-created single-session intervention for distress | Active comparator | Behavioral: The Action Brings Change (ABC) Program (TEAM Lab version) |
| (Study 2) Online help-seeking as usual | Active comparator | Behavioral: Online help-seeking as usual |
| (Study 3) Popular online content-based single-session intervention for loneliness | Experimental | Behavioral: The Lonely Blu Surfer program: a popular online content-based intervention for loneliness |
| (Study 3) Researcher-created single-session intervention for loneliness | Active comparator | Behavioral: Overcoming Loneliness single-session intervention |
| (Study 3) Single-session active control program | Active comparator | Behavioral: Single-session "Sharing Feelings" program |
| (Study 4) 23-minute loneliness program | Active comparator | Behavioral: Overcoming Loneliness single-session intervention |
| (Study 4) 8-minute loneliness program | Experimental | Behavioral: Overcoming loneliness SSI 8-minute version |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overcoming Loneliness three-week interventionA 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. | Behavioural | (Study 1) 3-week Loneliness Program |
| Overcoming Loneliness single-session interventionThe Overcoming Loneliness Three-Week Intervention condensed into a single-session intervention lasting 20-30 minutes. | Behavioural | (Study 1) Single-session loneliness program, (Study 3) Researcher-created single-session intervention for loneliness, (Study 4) 23-minute loneliness program |
| Single-session "Sharing Feelings" programA 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 | Behavioural | (Study 1) Single-session active control program, (Study 3) Single-session active control program |
| The Blu Surfer program: a popular online content-based intervention for psychological distressThe 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. | Behavioural | (Study 2) Popular online content-based single-session intervention for distress |
| 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. | Behavioural | (Study 2) Researcher-created single-session intervention for distress |
| Online help-seeking as usualThis 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. | Behavioural | (Study 2) Online help-seeking as usual |
| The Lonely Blu Surfer program: a popular online content-based intervention for lonelinessThe 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. | Behavioural | (Study 3) Popular online content-based single-session intervention for loneliness |
| Overcoming loneliness SSI 8-minute versionA 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. | Behavioural | (Study 4) 8-minute loneliness program |
Primary outcome
Change in UCLA Loneliness Scale Version 3 at 8 weeks
Time frame: 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
19 secondary outcomes
Change in UCLA Loneliness Scale Version 3 at 4 weeks
Time frame: Baseline, 4-week follow-up
Change in Depression Anxiety and Stress Scale - 9-item total score at 8 weeks
Time frame: Baseline, 8-week follow-up
Change in Depression Anxiety and Stress Scale - 9-item total score at 4 weeks
Time frame: Baseline, 4-week follow-up
Change in 3-item Mini Social Phobia Inventory at 8 weeks
Time frame: Baseline, 8-week follow-up
Change in 3-item Mini Social Phobia Inventory at 4 weeks
Time frame: Baseline, 4-week follow-up
Change in Short form of the General Self-Efficacy Scale at 8 weeks
Time frame: Baseline, 8-week follow-up
Change in Short form of the General Self-Efficacy Scale at 4 weeks
Time frame: Baseline, 4-week follow-up
Change in Short form of the General Self-Efficacy Scale immediately post-intervention
Time frame: 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 at 8 weeks
Time frame: Baseline, 8-week follow-up
Change in Beck Hopelessness Scale - 4-item at 4 weeks
Time frame: Baseline, 4-week follow-up
Change in Beck Hopelessness Scale - 4-item immediately post-intervention
Time frame: 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 8 weeks
Time frame: Baseline, 8-week follow-up
Change in Frequency of actions and thoughts scale at 4 weeks
Time frame: Baseline, 4-week follow-up
Program Feedback Scale
Time frame: 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)
Credibility and Expectancy Questionnaire
Time frame: 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)
Insight experience
Time frame: 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)
Star rating
Time frame: 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
Time frame: Baseline, 4-week follow-up
Change in PROMIS Meaning and Purpose in Life - 4-item at 8 weeks
Time frame: Baseline, 8-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 29407030Cacioppo 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.
- Background: PubMed 34339939Hickin 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.
- Background: PubMed 20716644Masi 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.
- Background: PubMed 32071885Kall 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.
- Background: PubMed 30315333Yamaguchi 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.
- Background: PubMed 34958980Rizvi 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.
- Background: PubMed 24347679Murphy 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.
- Background: PubMed 19996233Kroenke 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.
- Derived from this study: PubMed 39325409Kaveladze 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Loneliness
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Schueller, Ph.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overcoming Loneliness three-week intervention, Overcoming Loneliness single-session intervention and Single-session "Sharing Feelings" program in people with Loneliness and Mental Health Issue, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UCLA Loneliness Scale Version 3 at 8 weeks (time frame: Baseline, 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05687162, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.