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.

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.

Study Overview

• Status: Completed
• Conditions: Loneliness
• Intervention / Treatment: Other: SOLUS-D + weekly feedback by a coach; Other: SOLUS-D + weekly automated messages

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting control group
Experimental: Internet-based self-help + weekly feedback by a coach; Internet-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.	Other: SOLUS-D + weekly feedback by a coach; internet-based self-help
Experimental: Internet-based self-help + weekly automated messages; Internet-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.	Other: SOLUS-D + weekly automated messages; internet-based self-help

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Measured with the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27 (representing the sum of each of the 9 individual items). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.	Baseline, 5-week, 10-week, 6-months, 12-months
Satisfaction with Life	Measured with the Satisfaction with Life Scale (SWLS). Total score ranging from 1-7 (representing the mean score of all 5 items). Higher scores indicate higher satisfaction with life.	Baseline, 5-week, 10-week, 6-months, 12-months
Misanthropy	Measured with the subscale "Misanthropy" of the Embitterment Scale (BVI). Total score ranging from 0-4 (representing the mean score of all 5 items). Higher scores indicate a higher degree in misanthropy.	Baseline, 10-week, 6-months, 12-months
Self-Stigma in Loneliness	Measured with the Self-Stigma in Loneliness Questionnaire. Total score ranging from 1-5 (representing the mean score of all 6 items). Higher scores indicate higher self-stigma.	Baseline, 10-week, 6-months, 12-months
Social Interaction Anxiety	Measured with the Social Interaction Anxiety Scale, 6-Item Version (SIAS-6). Total score ranging from 0-5 (representing the mean score of all 6 items) Higher scores indicate higher social interaction anxiety.	Baseline, 10-week, 6-months, 12-months
Social Phobia	Measured with the Social Phobia Scale, 6-Item Version (SPS-6). Total score ranging from 0-5 (representing the mean score of all 6 items). Higher scores indicate higher social phobia.	Baseline, 10-week, 6-months, 12-months
Self-Compassion	Measured with the Sussex Oxford Compassion for the Self Scale (SOCS-S). Total score ranging from 1-5 (representing the mean score of all 20 items). Higher scores indicate higher self-compassion.	Baseline, 10-week, 6-months, 12-months
Social Network	Measured with the Social Network Index (SNI). Network Diversity ranging from 1-8 (representing the number of social roles in which the respondent has regular contact with at least one person). Higher scores indicate a more diverse social network. Number of people in Social Network ranging from 0 to infinity. Higher scores indicate a larger social network.	Baseline, 10-week, 6-months, 12-months
Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)		Baseline, 6-months
Interpretation and Judgmental Bias	Measured with the Interpretation and Judgmental Questionnaire (IJQ). The interpretation score ranges from 1-4 (representing the chosen likelihood of the profoundly negative alternative). Higher scores indicate more negatively biased processing.	Baseline, 5-week, 10-week, 6-months, 12-months
Rejection Sensitivity	Measured with the Rejection Sensitivity Questionnaire (A-RSQ). Total score ranging from 1-36 (representing the mean score of the multiplication of the subscales of all 9 items). Higher scores indicate higher rejection sensitivity.	Baseline, 5-week, 10-week, 6-months, 12-months
Behavioral-social Avoidance	Measured with the "behavioral-social avoidance"-subscale of the Cognitive-Behavioral Avoidance Scale (CBAS). Total score ranging from 1-5 (representing the mean score of all 8 items). Higher scores indicate higher behavioral-social avoidance.	Baseline, 5-week, 10-week, 6-months, 12-months
Distress Disclosure	Measured with the Distress Disclosure Index (DDI). Total score ranging from 1-5 (representing the mean score of all 12 items). Higher scores indicate higher levels of distress disclosure.	Baseline, 5-week, 10-week, 6-months, 12-months
Authenticity	Measured with the Kernis-Goldman Authenticity Inventory - Short Form (KGAI-SF). Total score ranging from 1-5 (representing the mean score of all 20 items). Higher scores indicate less authenticity.	Baseline, 5-week, 10-week, 6-months, 12-months
Negative Effects	Measured with the Inventory for the Assessment of Negative Effects of Psychotherapy (INEP). Total score ranging from -3-3 (representing the mean score of all items). Higher scores indicate less unfavourable effects of psychotherapy.	10-week
Client Satisfaction	Measured with the Client Satisfaction Questionnaire (ZUF-8). Total score ranging from 1-4 (representing the mean score of all 8 items). Higher scores indicate higher client satisfaction.	10-week
System Usability	Measured with the System Usability Scale (SUS). Total score ranging from 0-100 (representing the sum score multiplied by 2.5). Higher scores indicate higher perceived usability.	10-week
Self-esteem	Measured with the Rosenberg Self-Esteem Scale (RSES). Total score ranging from 0-30 (representing the sum of each of the 10 individual items). Higher scores indicate higher self-esteem.	Baseline, 10-week
Self-determined motivation for solitude	Measured with the subscale "self-determined motivation for solitude" of the Motivation for Solitude Scale - Short Form (MSS-SF). Total score ranging from 1-4 (representing the mean score of all 8 items). Higher scores indicate higher self-determined motivation for solitude.	Baseline, 10-week

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Tobias Krieger, PD Dr., University of Bern

Publications and helpful links

General Publications

• Seewer 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: loneliness; internet-based self-help
• Other Study ID Numbers: SOLUS-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No