Guided Online Self-help for Loneliness

Not Applicable

Completed

• Conditions: Loneliness
• Interventions: Behavioral: ICBT; Behavioral: IPT

• Registration Number: NCT03807154
• Lead Sponsor: Linkoeping University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-12
• Study First Posted: 2019-01-16
• Study Start: 2019-01-17
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based cognitive behavioral therapy (ICBT)	ICBT	A nine-week long ICBT intervention with therapist support.
Internet-based Interpersonal Therapy (IIPT)	IPT	A nine-week long intervention based in interpersonal psychotherapy with therapist support.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change on Brunnsviken Brief Quality of Life Scale (BBQ)	10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up	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.
Change on Patient Health Questionnaire (PHQ-9)	10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up	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.
Change on Social Interaction Anxiety Scale (SIAS)	10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up	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.
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-up	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.

Trial Locations

Locations (1)

Department of Behavioral Sciences and Learning, Linköping University; 🇸🇪 Linköping, Östergötland, Sweden