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Completed

NCT Number: NCT04655196

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SOLUS-D + weekly feedback by a coach

Other

internet-based self-help

SOLUS-D + weekly automated messages

Other

internet-based self-help

Primary outcomes

  1. Loneliness

    Time frame: 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 outcomes

  1. Depressive Symptoms

    Time frame: 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.

  2. Satisfaction with Life

    Time frame: 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.

  3. Misanthropy

    Time frame: 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.

  4. Self-Stigma in Loneliness

    Time frame: 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.

  5. Social Interaction Anxiety

    Time frame: 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.

  6. Social Phobia

    Time frame: 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.

  7. Self-Compassion

    Time frame: 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.

  8. Social Network

    Time frame: 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.

  9. Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)

    Time frame: Baseline, 6-months

  10. Interpretation and Judgmental Bias

    Time frame: 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.

  11. Rejection Sensitivity

    Time frame: 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.

  12. Behavioral-social Avoidance

    Time frame: 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.

  13. Distress Disclosure

    Time frame: 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.

  14. Authenticity

    Time frame: 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.

  15. Negative Effects

    Time frame: 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.

  16. Client Satisfaction

    Time frame: 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.

  17. System Usability

    Time frame: 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.

  18. Self-esteem

    Time frame: 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.

  19. Self-determined motivation for solitude

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: SOLUS-D

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 7, 2020
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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