Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness. (SOLUS-D)

November 6, 2023 updated by: University of Bern

A Randomized Controlled Trial to Evaluate 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
243

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Waiting control group
Experimental: Internet-based self-help + 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.
Other: SOLUS-D + weekly feedback by a coach
internet-based self-help
Experimental: Internet-based self-help + 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.
Other: SOLUS-D + weekly automated messages
internet-based self-help

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10-week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
Baseline, 10-week, 6-months, 12-months
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.
Baseline, 10-week, 6-months, 12-months
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.
Baseline, 10-week, 6-months, 12-months
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.
Baseline, 10-week, 6-months, 12-months
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.
Baseline, 10-week, 6-months, 12-months
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.
Baseline, 10-week, 6-months, 12-months
Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)
Time Frame: Baseline, 6-months
Baseline, 6-months
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
Baseline, 5-week, 10-week, 6-months, 12-months
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.
10-week
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.
10-week
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.
10-week
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.
Baseline, 10-week
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.
Baseline, 10-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tobias Krieger, PD Dr., University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOLUS-D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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