Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.

Loneliness Clinical Trial

— SOLUS-D  

Official title:

A Randomized Controlled Trial to Evaluate the Efficacy of Two Internet-based Self-help Interventions for Loneliness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655196
• Other study ID #: SOLUS-D
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: September 22, 2023

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: September 22, 2023
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Loneliness

Intervention

Other:
• SOLUS-D + weekly feedback by a coach
internet-based self-help
• SOLUS-D + weekly automated messages
internet-based self-help

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)		Baseline, 6-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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