Evaluating a Single-Session Intervention for Loneliness

Sponsor
University of California, Irvine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05687162
Collaborator
Jacobs Foundation (Other)
2,000
1
3
5.9
340.1

Study Details

Study Description

Brief Summary

The goal of this study is to examine the efficacy of an online single-session intervention (SSI) for loneliness.

It aims to answer is if a 20-30 minute online SSI based on an evidence-based internet cognitive behavioral therapy can reduce feelings of loneliness among lonely people.

type of study: clinical trial

participant population/health conditions: English-speakers aged 16 and older with access to internet and a computer, smartphone, or tablet who meet our criteria for struggling with loneliness.

Researchers will compare a 30-minute digital loneliness SSI to a 3-week loneliness digital mental health intervention (DMHI) and a control SSI in their efficacy in reducing loneliness.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Overcoming Loneliness three-week intervention
  • Behavioral: Overcoming Loneliness single-session intervention
  • Behavioral: Single-session "Sharing Feelings" program
N/A

Detailed Description

Severe loneliness is globally prevalent and is strongly associated with impaired mental and physical well-being, making it a significant public health issue (J. T. Cacioppo & Cacioppo, 2018b). Evidence-based interventions for loneliness reach a small subset of people who might benefit from them (Hickin et al., 2021; Masi et al., 2011), 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 (Käll, 2021) into a 3-week version and a 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 (see attached table for timing of measures). 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 Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We will randomly assign participants to complete one of three online programs, assessing DVs at baseline and 4 and 8 weeks later.We will randomly assign participants to complete one of three online programs, assessing DVs at baseline and 4 and 8 weeks later.
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Brief Internet Interventions to Reduce Loneliness
Actual Study Start Date :
Dec 4, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 3-week Loneliness Program

The second and third sessions are completed in the second and third week, respectively, after beginning the study.

Behavioral: Overcoming Loneliness three-week intervention
A self-guided online loneliness intervention with three 10-20 minute sessions. The intervention content draws heavily from Anton Käll et al.'s Internet Cognitive Behavioral Therapy for Loneliness and follows the form of Jessica Schleider et al.'s single-session mental health interventions.

Experimental: Single-session loneliness program

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

Active Comparator: Single-session active control program

Behavioral: Single-session "Sharing Feelings" program
A self-guided online supportive therapy intervention with a single 20-30 minute session intended to encourage users to share feelings with close others. Slightly modified from Jessica Schleider et al.'s "Sharing Feelings" intervention

Outcome Measures

Primary Outcome Measures

  1. Change in UCLA Loneliness Scale Version 3 at 8 weeks [Baseline, 8-week follow-up]

    A 20-item measure of trait loneliness

Secondary Outcome Measures

  1. Change in UCLA Loneliness Scale Version 3 at 4 weeks [Baseline, 4-week follow-up]

    A 20-item measure of trait loneliness

  2. Change in Depression Anxiety and Stress Scale - 9-item at 8 weeks [Baseline, 8-week follow-up]

    A brief scale with subscales measuring depression, anxiety, and stress

  3. Change in Depression Anxiety and Stress Scale - 9-item at 4 weeks [Baseline, 4-week follow-up]

    A brief scale with subscales measuring depression, anxiety, and stress

  4. Change in 3-item Mini Social Phobia Inventory at 8 weeks [Baseline, 8-week follow-up]

    A brief measure of social anxiety

  5. Change in 3-item Mini Social Phobia Inventory at 4 weeks [Baseline, 4-week follow-up]

    A brief measure of social anxiety

  6. Change in Short form of the General Self-Efficacy Scale at 8 weeks [Baseline, 8-week follow-up]

    A 6-item measure of general self-efficacy

  7. Change in Short form of the General Self-Efficacy Scale at 4 weeks [Baseline, 4-week follow-up]

    A 6-item measure of general self-efficacy

  8. Change in Short form of the General Self-Efficacy Scale immediately post-intervention [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)]

    A 6-item measure of general self-efficacy

  9. Change in Beck Hopelessness Scale - 4-item at 8 weeks [Baseline, 8-week follow-up]

    A brief version of a hopelessness measure

  10. Change in Beck Hopelessness Scale - 4-item at 4 weeks [Baseline, 4-week follow-up]

    A brief version of a hopelessness measure

  11. Change in Beck Hopelessness Scale - 4-item immediately post-intervention [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)]

    A brief version of a hopelessness measure

  12. Change in Frequency of actions and thoughts scale at 8 weeks [Baseline, 8-week follow-up]

    A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of cognitive behavioral therapy

  13. Change in Frequency of actions and thoughts scale at 4 weeks [Baseline, 4-week follow-up]

    A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of cognitive behavioral therapy

  14. Program Feedback Scale [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)]

    A 7-item measure of engagement with and acceptability of SSIs

  15. Credibility and Expectancy Questionnaire [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)]

    A 4-item measure of user-perceived intervention appeal and efficacy

  16. Insight experience [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)]

    A 1-item measure of whether one experienced an insight moment as a result of the program

  17. Star rating [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)]

    A rating of program quality, from 1-5 stars

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Be fluent in English

  • Be 16 years old +

  • Have internet access and a computer, smartphone, or tablet

  • To be paid for participation, must meet our 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.

Exclusion Criteria:
  • Having completed the study in the past

  • Failing both of the attention checks in the baseline measures.

  • Spending less than 2 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Online (based at UC Irvine) Irvine California United States 92697

Sponsors and Collaborators

  • University of California, Irvine
  • Jacobs Foundation

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Stephen Matthew Schueller, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT05687162
Other Study ID Numbers:
  • 1253
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 18, 2023