A Randomized Controlled Trial to Evaluate the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Loneliness
- Sponsor
- University of Bern
- Enrollment
- 243
- Locations
- 1
- Primary Endpoint
- Loneliness
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Loneliness
Time Frame: 10-week
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.
Secondary Outcomes
- Depressive Symptoms(Baseline, 5-week, 10-week, 6-months, 12-months)
- Interpretation and Judgmental Bias(Baseline, 5-week, 10-week, 6-months, 12-months)
- Behavioral-social Avoidance(Baseline, 5-week, 10-week, 6-months, 12-months)
- System Usability(10-week)
- Self-Stigma in Loneliness(Baseline, 10-week, 6-months, 12-months)
- Satisfaction with Life(Baseline, 5-week, 10-week, 6-months, 12-months)
- Rejection Sensitivity(Baseline, 5-week, 10-week, 6-months, 12-months)
- Negative Effects(10-week)
- Social Interaction Anxiety(Baseline, 10-week, 6-months, 12-months)
- Self-Compassion(Baseline, 10-week, 6-months, 12-months)
- Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)(Baseline, 6-months)
- Authenticity(Baseline, 5-week, 10-week, 6-months, 12-months)
- Misanthropy(Baseline, 10-week, 6-months, 12-months)
- Social Network(Baseline, 10-week, 6-months, 12-months)
- Distress Disclosure(Baseline, 5-week, 10-week, 6-months, 12-months)
- Client Satisfaction(10-week)
- Self-esteem(Baseline, 10-week)
- Self-determined motivation for solitude(Baseline, 10-week)
- Social Phobia(Baseline, 10-week, 6-months, 12-months)