Clinical trial NCT04655196: Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Keywords: internet-based self-help
loneliness
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2020-12-07
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Loneliness
timeFrame: 10-week
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Satisfaction with Life
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Misanthropy
timeFrame: Baseline, 10-week, 6-months, 12-months
measure: Self-Stigma in Loneliness
timeFrame: Baseline, 10-week, 6-months, 12-months
measure: Social Interaction Anxiety
timeFrame: Baseline, 10-week, 6-months, 12-months
measure: Social Phobia
timeFrame: Baseline, 10-week, 6-months, 12-months
measure: Self-Compassion
timeFrame: Baseline, 10-week, 6-months, 12-months
measure: Social Network
timeFrame: Baseline, 10-week, 6-months, 12-months
measure: Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)
timeFrame: Baseline, 6-months
measure: Interpretation and Judgmental Bias
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Rejection Sensitivity
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Behavioral-social Avoidance
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Distress Disclosure
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Authenticity
timeFrame: Baseline, 5-week, 10-week, 6-months, 12-months
measure: Negative Effects
timeFrame: 10-week
measure: Client Satisfaction
timeFrame: 10-week
measure: System Usability
timeFrame: 10-week
measure: Self-esteem
timeFrame: Baseline, 10-week
measure: Self-determined motivation for solitude
timeFrame: Baseline, 10-week
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Tobias Krieger, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.