LonelinessNCT03807154
Guided Online Self-help for Loneliness
A study testing ICBT and IPT in people with Loneliness, run by Linkoeping University at 1 site in Sweden.
Trial summary
The study seeks to investigate the efficacy of two internet-based self-help programmes administered with support from a therapist. The two active conditions consist of an internet cognitive behavioral therapy (ICBT) programme and a intervention of internet-based interpersonal psychotherapy (IIPT), both of which have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness
- What is being tested?
- ICBT and IPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jan 2019to 1 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Frequent and distressing experiences of loneliness
- Can speak, write, and read the primary language of the country in which they reside (Sweden or the United Kingdom).
- Have access to an internet connection and a computer/smart phone/tablet
- Are prepared to participate in the study, regardless of the type of treatment they are randomly assigned to.
Who cannot join
- Changes in dosage of psychopharmaceutic medication in the last three months prior to the start of the study or a planned change during the initial treatment period.
- Other ongoing psychotherapeutic treatment
- Suicidal plans
- A previously diagnosed personality syndrome
- Ongoing substance abuse
- Other acute treatment need related to a psychiatric disorder requiring attention from a mental health professional (e.g. eating disorders such as anorexia nervosa).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: SOLUS - A Randomized Controlled Two-site Trial Comparing Internet-based Cognitive Behavioral Therapy and Internet-based Interpersonal Psychotherapy
The study seeks to investigate the efficacy of two internet-based self-help programmes administered with support from a therapist. The two active conditions consist of an internet cognitive behavioral therapy (ICBT) programme and a intervention of internet-based interpersonal psychotherapy (IIPT), both of which have been developed for the present study. The active conditions will be compared to a wait-list control group.
Participants will be recruited in Sweden with a nationwide recruitment.
- Conditions
- Loneliness
- Being tested
- ICBT, IPT
- Keywords
- Loneliness, ICBT, Internet-based psychotherapy, Cognitive behavioral therapy, Interpersonal psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBTBehavioural
A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.
IPTBehavioural
A nine week long internet-based IPT-programme with therapist guidance. Contains three distinct phases: assessment phase (three weeks), focus phase (five weeks, during which the participants will choose from one of four primary problem areas during the three latter weeks), and end phase (one week).
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavioral therapy (ICBT) | Experimental | A nine-week long ICBT intervention with therapist support. Receives: Behavioral: ICBT |
| Internet-based Interpersonal Therapy (IIPT) | Experimental | A nine-week long intervention based in interpersonal psychotherapy with therapist support. Receives: Behavioral: IPT |
| Wait-list | No intervention | Wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)
Measure of loneliness, total score ranging from 20-80 (representing the sum of each of the 20 individual items). Lower scores represent less loneliness and a more favourable outcome.
Measured: During week 2, 4, 6, and 8 of the intervention, 10 weeks after start of intervention, 4 months after completion of intervention, 12 months after start of intervention.
Secondary outcomes (4)
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
Measured: 10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up
Change on Patient Health Questionnaire (PHQ-9)
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Measured: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Change on Social Interaction Anxiety Scale (SIAS)
Measure of social interaction anxiety, closely correlated with social anxiety disorder. The score on each of the 20 items are summed up. Possible range for the total sum between 0 and 80. Higher scores indicate a higher degree of social interaction anxiety.
Measured: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
Measure of symptoms of generalised anxiety disorder (GAD). Seven items, the score is interpreted by summing up the score from each individual item. Higher scores indicate more severe problems with worry and generalised anxiety. The total sum ranges from 0 to 21 with cut-offs of 5, 10, and 15 representing mild, moderate and severe generalised anxiety.
Measured: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start17 Jan 2019
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Model description
- Three conditions: Internet-based Cognitive behavioral therapy, Internet-based Interpersonal psychotherapy, and a wait-list during the primary treatment phase. The wait-list will be allocated to the two active conditions once the primary treatment phase has finished.
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807154
- Sponsor's protocol ID
- SOLUS
- Status last verified
- Sep 2022
- First submitted
- 9 Jan 2019
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kall A, Back M, Welin C, Aman H, Bjerkander R, Wanman M, Lindegaard T, Berg M, Moche H, Shafran R, Andersson G. Therapist-Guided Internet-Based Treatments for Loneliness: A Randomized Controlled Three-Arm Trial Comparing Cognitive Behavioral Therapy and Interpersonal Psychotherapy. Psychother Psychosom. 2021;90(5):351-358. doi: 10.1159/000516989. Epub 2021 Jun 28.
PubMed 34182552
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLUS - A Randomized Controlled Two-site Trial Comparing Internet-based Cognitive Behavioral Therapy and Internet-based Interpersonal Psychotherapy
- ClinicalTrials.gov ID
- NCT03807154
- Acronym / sponsor ID
- SOLUS
- Conditions
- Loneliness
- Keywords
- Loneliness, ICBT, Internet-based psychotherapy, Cognitive behavioral therapy, Interpersonal psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University College, London
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 16 Jan 2019 (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.
The study seeks to investigate the efficacy of two internet-based self-help programmes administered with support from a therapist. The two active conditions consist of an internet cognitive behavioral therapy (ICBT) programme and a intervention of internet-based interpersonal psychotherapy (IIPT), both of which have been developed for the present study. The active conditions will be compared to a wait-list control group.
Participants will be recruited in Sweden with a nationwide recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three conditions: Internet-based Cognitive behavioral therapy, Internet-based Interpersonal psychotherapy, and a wait-list during the primary treatment phase. The wait-list will be allocated to the two active conditions once the primary treatment phase has finished.
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioral therapy (ICBT) | Experimental | Behavioral: ICBTA nine-week long ICBT intervention with therapist support. |
| Internet-based Interpersonal Therapy (IIPT) | Experimental | Behavioral: IPTA nine-week long intervention based in interpersonal psychotherapy with therapist support. |
| Wait-list | No intervention | –Wait-list control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Frequent and distressing experiences of loneliness
- Can speak, write, and read the primary language of the country in which they reside (Sweden or the United Kingdom).
- Have access to an internet connection and a computer/smart phone/tablet
- Are prepared to participate in the study, regardless of the type of treatment they are randomly assigned to.
Key exclusion criteria (6 listed)
- Changes in dosage of psychopharmaceutic medication in the last three months prior to the start of the study or a planned change during the initial treatment period.
- Other ongoing psychotherapeutic treatment
- Suicidal plans
- A previously diagnosed personality syndrome
- Ongoing substance abuse
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 |
|---|---|---|
| ICBTA nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness. | Behavioural | Internet-based cognitive behavioral therapy (ICBT) |
| IPTA nine week long internet-based IPT-programme with therapist guidance. Contains three distinct phases: assessment phase (three weeks), focus phase (five weeks, during which the participants will choose from one of four primary problem areas during the three latter weeks), and end phase (one week). | Behavioural | Internet-based Interpersonal Therapy (IIPT) |
Primary outcome
Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)
Time frame: During week 2, 4, 6, and 8 of the intervention, 10 weeks after start of intervention, 4 months after completion of intervention, 12 months after start of intervention.
Measure of loneliness, total score ranging from 20-80 (representing the sum of each of the 20 individual items). Lower scores represent less loneliness and a more favourable outcome.
4 secondary outcomes
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: 10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up
Change on Patient Health Questionnaire (PHQ-9)
Time frame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Change on Social Interaction Anxiety Scale (SIAS)
Time frame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
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 19 Sep 2022.
- Derived from this study: PubMed 34182552Kall A, Back M, Welin C, Aman H, Bjerkander R, Wanman M, Lindegaard T, Berg M, Moche H, Shafran R, Andersson G. Therapist-Guided Internet-Based Treatments for Loneliness: A Randomized Controlled Three-Arm Trial Comparing Cognitive Behavioral Therapy and Interpersonal Psychotherapy. Psychother Psychosom. 2021;90(5):351-358. doi: 10.1159/000516989. Epub 2021 Jun 28.
- Individual participant dataSharing planned: No
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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.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT and IPT in people with Loneliness, run by Linkoeping University at 1 site in Sweden.
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 4 inclusion and 6 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 19 Sep 2022. 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 Sweden. 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?
Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3) (time frame: During week 2, 4, 6, and 8 of the intervention, 10 weeks after start of intervention, 4 months after completion of intervention, 12 months after start of intervention.). 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 NCT03807154, which also lists 1 linked publication.
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 19 Sep 2022.