Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
SOLUS-D
A Randomized Controlled Trial to Evaluate the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
1 other identifier
interventional
243
1 country
1
Brief Summary
In this study, people who suffer from loneliness will be randomized to three study conditions. The first and second group get an account to an internet-based self-help intervention. The first group also receives weekly feedback from a coach and the second group receives an automated email on a weekly basis. The third group is a waiting control group. In all three conditions additional care or treatment is allowed. The aim of the study is to investigate the efficacy of an internet-based self-help intervention to reduce feelings of loneliness compared to a waiting list and the effect of support during the intervention. Assessments are at baseline, 5-week, 10-week, 6-months and 12-months post-randomization. Participants in the waiting control group get also access to the intervention and fill out questionnaires at baseline, 5-week and 10-week post-randomization and get also access to the intervention 10 weeks after randomization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2023
CompletedNovember 7, 2023
November 1, 2023
1.5 years
November 27, 2020
November 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Loneliness
Measured with the UCLA Loneliness Scale, 9-Item Version (UCLA-9). Total score ranging from 1-4 (representing the mean score of all 9 items). Lower scores represent less loneliness and a more favourable outcome.
10-week
Secondary Outcomes (19)
Depressive Symptoms
Baseline, 5-week, 10-week, 6-months, 12-months
Satisfaction with Life
Baseline, 5-week, 10-week, 6-months, 12-months
Misanthropy
Baseline, 10-week, 6-months, 12-months
Self-Stigma in Loneliness
Baseline, 10-week, 6-months, 12-months
Social Interaction Anxiety
Baseline, 10-week, 6-months, 12-months
- +14 more secondary outcomes
Study Arms (3)
Internet-based self-help + weekly feedback by a coach
EXPERIMENTALInternet-based self-help on the basis of CBT-interventions, mindfulness and self-compassion to address cognitions, emotions and behavior related to loneliness. The self-help program consists of nine text, audio and video-based sessions, various exercises (e.g., breathing meditation, diaries) and tasks. Participants receive weekly feedback by a coach.
Internet-based self-help + weekly automated messages
EXPERIMENTALInternet-based self-help on the basis of CBT-interventions, mindfulness and self-compassion to address cognitions, emotions and behavior related to loneliness. The self-help program consists of nine text-, audio- and video-based sessions, various exercises (e.g., breathing meditation, diaries) and tasks. Participants receive weekly automated messages in order to increase motivation.
Waiting control group
NO INTERVENTIONInterventions
internet-based self-help
internet-based self-help
Eligibility Criteria
You may qualify if:
- Sumscore ≥ 18 on the UCLA Loneliness Scale
- Signed Informed Consent
- Contact information provided in case of emergency
- Internet connection and device to use it (Smartphone, Computer, Tablet)
- Fluent in german language
You may not qualify if:
- Acute suicidality
- A current diagnose of substance dependence, a current or previous diagnose of psychotic disorder or bipolar disorder
- A current diagnosis of severe depression (PHQ-9 \> 14)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- Swiss National Science Foundationcollaborator
Study Sites (1)
University of Bern
Bern, 3012, Switzerland
Related Publications (2)
Seewer N, Skoko A, Kall A, Andersson G, Luhmann M, Berger T, Krieger T. Efficacy of an Internet-based self-help intervention with human guidance or automated messages to alleviate loneliness: a three-armed randomized controlled trial. Sci Rep. 2024 Mar 19;14(1):6569. doi: 10.1038/s41598-024-57254-0.
PMID: 38503870DERIVEDSeewer N, Skoko A, Kall A, Andersson G, Luhmann M, Berger T, Krieger T. Evaluating the Efficacy of a Guided and Unguided Internet-Based Self-help Intervention for Chronic Loneliness: Protocol for a 3-Arm Randomized Controlled Trial. JMIR Res Protoc. 2022 Jul 22;11(7):e36358. doi: 10.2196/36358.
PMID: 35867403DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Krieger, PD Dr.
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2020
First Posted
December 7, 2020
Study Start
May 17, 2021
Primary Completion
November 18, 2022
Study Completion
September 22, 2023
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share