LonelinessSOLUS-DNCT04655196
Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
A study testing SOLUS-D + weekly feedback by a coach and SOLUS-D + weekly automated messages in people with Loneliness, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- SOLUS-D + weekly feedback by a coach and SOLUS-D + weekly automated messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 May 2021to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Loneliness
- Being tested
- SOLUS-D + weekly feedback by a coach, SOLUS-D + weekly automated messages
- Keywords
- internet-based self-help, loneliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLUS-D + weekly feedback by a coachOther
internet-based self-help
SOLUS-D + weekly automated messagesOther
internet-based self-help
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SOLUS-D + weekly feedback by a coach |
| 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. Receives: Other: SOLUS-D + weekly automated messages |
| Waiting control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-week
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 10-week, 6-months, 12-months
Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 10-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start17 May 2021
- Primary completion18 Nov 2022
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Tobias Krieger, PD Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655196
- Sponsor's protocol ID
- SOLUS-D
- Acronym
- SOLUS-D
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38503870Seewer 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.
PubMed 35867403
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
- ClinicalTrials.gov ID
- NCT04655196
- Acronym / sponsor ID
- SOLUS-D / SOLUS-D
- Conditions
- Loneliness
- Keywords
- internet-based self-help, loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 17 May 2021 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-based self-help + weekly feedback by a coach | Experimental | Other: SOLUS-D + weekly feedback by a coachInternet-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 | Experimental | Other: SOLUS-D + weekly automated messagesInternet-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. |
| Waiting control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOLUS-D + weekly feedback by a coachinternet-based self-help | Other | Internet-based self-help + weekly feedback by a coach |
| SOLUS-D + weekly automated messagesinternet-based self-help | Other | Internet-based self-help + weekly automated messages |
Primary outcome
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.
19 secondary outcomes
Depressive Symptoms
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Satisfaction with Life
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Misanthropy
Time frame: Baseline, 10-week, 6-months, 12-months
Self-Stigma in Loneliness
Time frame: Baseline, 10-week, 6-months, 12-months
Social Interaction Anxiety
Time frame: Baseline, 10-week, 6-months, 12-months
Social Phobia
Time frame: Baseline, 10-week, 6-months, 12-months
Self-Compassion
Time frame: Baseline, 10-week, 6-months, 12-months
Social Network
Time frame: Baseline, 10-week, 6-months, 12-months
Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)
Time frame: Baseline, 6-months
Interpretation and Judgmental Bias
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Rejection Sensitivity
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Behavioral-social Avoidance
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Distress Disclosure
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Authenticity
Time frame: Baseline, 5-week, 10-week, 6-months, 12-months
Negative Effects
Time frame: 10-week
Client Satisfaction
Time frame: 10-week
System Usability
Time frame: 10-week
Self-esteem
Time frame: Baseline, 10-week
Self-determined motivation for solitude
Time frame: Baseline, 10-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 38503870Seewer 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.
- Derived from this study: PubMed 35867403Seewer 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.
- Individual participant dataSharing planned: Yes
Related trials for Loneliness
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Krieger, PD Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOLUS-D + weekly feedback by a coach and SOLUS-D + weekly automated messages in people with Loneliness, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: 10-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.