Guided Online Self-help for Loneliness

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807154
• Other study ID #: SOLUS
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2022
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Loneliness

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Behavioral Sciences and Learning, Linköping University	Linköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	University College, London

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up
Secondary	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.	10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Secondary	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.	10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Secondary	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.	10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up