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| Name | Class |
|---|---|
| Jacobs Foundation | UNKNOWN |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (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. |
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| (Study 1) Single-session loneliness program | Experimental |
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| (Study 1) Single-session active control program | Active Comparator |
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| (Study 2) Popular online content-based single-session intervention for distress | Experimental |
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| (Study 2) Researcher-created single-session intervention for distress | Active Comparator |
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| (Study 2) Online help-seeking as usual | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overcoming Loneliness three-week intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 4-week follow-up |
| Change in Depression Anxiety and Stress Scale - 9-item total score at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Schueller, Ph.D. | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Online (based at UC Irvine) | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29407030 | Background | 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. | |
| 34339939 | Background | Hickin 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. |
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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.
The data will be available as soon as it is cleaned and de-identified and it will remain publicly available as long as possible.
The data will be available to the public via an online dataset on the Open Science Framework (osf.io)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2023 |
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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.
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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.
| (Study 3) Popular online content-based single-session intervention for loneliness | Experimental |
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| (Study 3) Researcher-created single-session intervention for loneliness | Active Comparator |
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| (Study 3) Single-session active control program | Active Comparator |
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| (Study 4) 23-minute loneliness program | Active Comparator |
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| (Study 4) 8-minute loneliness program | Experimental |
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| Overcoming Loneliness single-session intervention | Behavioral | The Overcoming Loneliness Three-Week Intervention condensed into a single-session intervention lasting 20-30 minutes. |
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| Single-session "Sharing Feelings" program | Behavioral | 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 |
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| The Blu Surfer program: a popular online content-based intervention for psychological distress | Behavioral | 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. |
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| The Action Brings Change (ABC) Program (TEAM Lab version) | Behavioral | 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. |
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| Online help-seeking as usual | Behavioral | 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. |
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| The Lonely Blu Surfer program: a popular online content-based intervention for loneliness | Behavioral | 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. |
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| Overcoming loneliness SSI 8-minute version | Behavioral | 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. |
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A brief scale with subscales measuring depression, anxiety, and stress. Range 0-27 with higher scores indicating greater symptom severity. Included in all studies. |
| 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 8-week follow-up |
| 20716644 | Background | Masi 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. |
| 32071885 | Background | Kall 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. |
| 30315333 | Background | Yamaguchi 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. |
| 34958980 | Background | Rizvi 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. |
| 24347679 | Background | Murphy 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. |
| 19996233 | Background | Kroenke 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. |
| 39325409 | Derived | Kaveladze 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. |
| Apr 7, 2023 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| C106538 | abacavir |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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