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Guided Online Self-help for Loneliness

SOLUS - A Randomized Controlled Two-site Trial Comparing Internet-based Cognitive Behavioral Therapy and Internet-based Interpersonal Psychotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807154
Enrollment
170
Registered
2019-01-16
Start date
2019-01-17
Completion date
2022-02-01
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness

Keywords

Loneliness, ICBT, Internet-based psychotherapy, Cognitive behavioral therapy, Interpersonal psychotherapy

Brief 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 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.

Interventions

BEHAVIORALICBT

A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.

BEHAVIORALIPT

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).

Sponsors

University College, London
CollaboratorOTHER
Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)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.

Secondary

MeasureTime frameDescription
Change on Brunnsviken Brief Quality of Life Scale (BBQ)10 weeks after start of intervention, at 4 month follow-up, 12 month follow-upMeasure 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.
Change on Patient Health Questionnaire (PHQ-9)10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-upMeasure 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.
Change on Social Interaction Anxiety Scale (SIAS)10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-upMeasure 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.
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-upMeasure 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026