SSIs for Mental Health and Loneliness

Depression Clinical Trial

Official title:

Brief Internet Interventions to Support Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687162
• Other study ID #: 1253
• Status: Completed
• Phase: N/A
• Start date: December 4, 2022
• Est. completion date: September 6, 2023

Study information

• Verified date: October 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4108
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Be fluent in English
• Be 16 years old +
• Have internet access and a computer, smartphone, or tablet
• To be compensated for participation and be included in the main analysis, participants in studies 1 and 2 must meet criteria for "struggling with loneliness" (ie, a score on the 3-item loneliness screen of at least 6, and indicating that one's loneliness is causing one distress). Otherwise, participants can still participate in the study on a volunteer basis.
• To be compensated for participation and be included in the main analysis, participants in study 3 must meet criteria for "struggling with distress" (ie, a score on either the depression or anxiety subscale greater than or equal to 3 (range 0-6), as these scores are suggestive of a depressive or anxiety disorder.

Exclusion Criteria:

• Having completed the study in the past
• Failing both of the attention checks in the baseline measures.
• Spending less than 3 minutes completing the study introduction and baseline measures (ie, were very likely bots)
• Indicating, at the end of the study, that one did not complete the study seriously and that one's data should not be included in analyses.

Related Conditions & MeSH terms

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

Intervention

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.
• Overcoming Loneliness single-session intervention
The Overcoming Loneliness Three-Week Intervention condensed into a single-session intervention lasting 20-30 minutes.
• 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
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Online (based at UC Irvine)	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Jacobs Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and 2b	Baseline, 8-week follow-up
Secondary	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
Secondary	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.	Baseline, 8-week follow-up
Secondary	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 all studies.	Baseline, 4-week follow-up
Secondary	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
Secondary	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
Secondary	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 all studies.	Baseline, 8-week follow-up
Secondary	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 all studies.	Baseline, 4-week follow-up
Secondary	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 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)
Secondary	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
Secondary	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 all studies.	Baseline, 4-week follow-up
Secondary	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)
Secondary	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
Secondary	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 all studies.	Baseline, 4-week follow-up
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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