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NCT04655196: SOLUS-D
Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
NA trial testing SOLUS-D + weekly feedback by a coach in Loneliness in 243 participants. Completed in 22 September 2023.
18 November 2022
Quick facts
| Lead sponsor | University of Bern |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 243 |
| Start date | 17 May 2021 |
| Primary completion | 18 November 2022 |
| Estimated completion | 22 September 2023 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- SOLUS-D + weekly feedback by a coach
- SOLUS-D + weekly automated messages
Conditions studied
- Loneliness — all drugs for Loneliness →
Sponsor
University of Bern
Who can join
18 and older, any sex, with Loneliness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy of an Internet-based self-help intervention with human guidance or automated messages to alleviate loneliness: a three-armed randomized controlled trial.
Seewer N, Skoko A, Käll A, Andersson G, et al · · 2024 · cited 11× · PMID 38503870 · DOI 10.1038/s41598-024-57254-0 -
Evaluating the Efficacy of a Guided and Unguided Internet-Based Self-help Intervention for Chronic Loneliness: Protocol for a 3-Arm Randomized Controlled Trial.
Seewer N, Skoko A, Käll A, Andersson G, et al · · 2022 · cited 6× · PMID 35867403 · DOI 10.2196/36358 -
Predictors and moderators of outcome of ICBT for loneliness with guidance or automated messages - A secondary analysis of a randomized controlled trial.
Seewer N, Skoko A, Käll A, Andersson G, et al · · 2024 · cited 2× · PMID 38192685 · DOI 10.1016/j.invent.2023.100701 -
Efficacy of an Internet-based Self-help Intervention with Human Guidance or Automated Messages to Alleviate Loneliness: A Three-Armed Randomized Controlled Trial
Seewer N, Skoko A, Käll A, Andersson G, et al · · 2023 · DOI 10.21203/rs.3.rs-3005279/v1
Verify or expand the search:
- PubMed search for NCT04655196
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04655196 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bern
- Last refreshed: 7 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04655196.
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