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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based self-help + weekly feedback by a coach | Experimental | Internet-based self-help on the basis of CBT-interventions, mindfulness and self-compassion to address cognitions, emotions and behavior related to loneliness. The self-help program consists of nine text, audio and video-based sessions, various exercises (e.g., breathing meditation, diaries) and tasks. Participants receive weekly feedback by a coach. |
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| Internet-based self-help + weekly automated messages | Experimental | Internet-based self-help on the basis of CBT-interventions, mindfulness and self-compassion to address cognitions, emotions and behavior related to loneliness. The self-help program consists of nine text-, audio- and video-based sessions, various exercises (e.g., breathing meditation, diaries) and tasks. Participants receive weekly automated messages in order to increase motivation. |
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| Waiting control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOLUS-D + weekly feedback by a coach | Other | internet-based self-help |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Krieger, PD Dr. | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern | Bern | 3012 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38503870 | Derived | Seewer N, Skoko A, Kall A, Andersson G, Luhmann M, Berger T, Krieger T. Efficacy of an Internet-based self-help intervention with human guidance or automated messages to alleviate loneliness: a three-armed randomized controlled trial. Sci Rep. 2024 Mar 19;14(1):6569. doi: 10.1038/s41598-024-57254-0. | |
| 35867403 | Derived |
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| SOLUS-D + weekly automated messages | Other | internet-based self-help |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS) | Baseline, 6-months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |