Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
- Conditions
- Loneliness
- Interventions
- Other: SOLUS-D + weekly feedback by a coachOther: SOLUS-D + weekly automated messages
- Registration Number
- NCT04655196
- Lead Sponsor
- University of Bern
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based self-help + weekly feedback by a coach SOLUS-D + weekly feedback by a coach 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. Internet-based self-help + weekly automated messages SOLUS-D + weekly automated messages 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.
- Primary Outcome Measures
Name Time Method Loneliness 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 Outcome Measures
Name Time Method Depressive Symptoms Baseline, 5-week, 10-week, 6-months, 12-months 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.
Interpretation and Judgmental Bias Baseline, 5-week, 10-week, 6-months, 12-months 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.
Behavioral-social Avoidance Baseline, 5-week, 10-week, 6-months, 12-months 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.
System Usability 10-week 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.
Satisfaction with Life Baseline, 5-week, 10-week, 6-months, 12-months 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.
Rejection Sensitivity Baseline, 5-week, 10-week, 6-months, 12-months 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.
Negative Effects 10-week 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.
Self-Stigma in Loneliness Baseline, 10-week, 6-months, 12-months 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.
Social Interaction Anxiety Baseline, 10-week, 6-months, 12-months 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.
Self-Compassion Baseline, 10-week, 6-months, 12-months 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.
Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS) Baseline, 6-months Authenticity Baseline, 5-week, 10-week, 6-months, 12-months 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.
Misanthropy Baseline, 10-week, 6-months, 12-months 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.
Social Network Baseline, 10-week, 6-months, 12-months 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.
Distress Disclosure Baseline, 5-week, 10-week, 6-months, 12-months 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.
Client Satisfaction 10-week 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.
Self-esteem Baseline, 10-week 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.
Self-determined motivation for solitude Baseline, 10-week 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.
Social Phobia Baseline, 10-week, 6-months, 12-months 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.
Trial Locations
- Locations (1)
University of Bern
🇨🇭Bern, Switzerland