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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04655196
Acronym
SOLUS-D
Enrollment
243
Registered
2020-12-07
Start date
2021-05-17
Completion date
2023-09-22
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness

Keywords

internet-based self-help, loneliness

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.

Interventions

OTHERSOLUS-D + weekly feedback by a coach

internet-based self-help

OTHERSOLUS-D + weekly automated messages

internet-based self-help

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Loneliness10-weekMeasured 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

MeasureTime frameDescription
Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)Baseline, 6-months
Depressive SymptomsBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
Satisfaction with LifeBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
MisanthropyBaseline, 10-week, 6-months, 12-monthsMeasured 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.
Self-Stigma in LonelinessBaseline, 10-week, 6-months, 12-monthsMeasured 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.
Social Interaction AnxietyBaseline, 10-week, 6-months, 12-monthsMeasured 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.
Social PhobiaBaseline, 10-week, 6-months, 12-monthsMeasured 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.
Self-CompassionBaseline, 10-week, 6-months, 12-monthsMeasured 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.
Social NetworkBaseline, 10-week, 6-months, 12-monthsMeasured 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.
Interpretation and Judgmental BiasBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
Rejection SensitivityBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
Behavioral-social AvoidanceBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
Distress DisclosureBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
AuthenticityBaseline, 5-week, 10-week, 6-months, 12-monthsMeasured 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.
Negative Effects10-weekMeasured 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.
Client Satisfaction10-weekMeasured 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.
System Usability10-weekMeasured 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.
Self-esteemBaseline, 10-weekMeasured 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.
Self-determined motivation for solitudeBaseline, 10-weekMeasured 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026