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

Study Overview
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Brief Summary
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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.

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

Conditions
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Loneliness

Intervention / Treatment
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* Other: SOLUS-D + weekly feedback by a coach
* Other: SOLUS-D + weekly automated messages


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based self-help + weekly feedback by a coach<br>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. | Other: SOLUS-D + weekly feedback by a coach<br>* internet-based self-help<br>|
| Experimental: Internet-based self-help + weekly automated messages<br>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. | Other: SOLUS-D + weekly automated messages<br>* internet-based self-help<br>|
| No Intervention: Waiting control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet-based self-help, loneliness