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Clinical Trials/NCT03807154
NCT03807154
Completed
Not Applicable

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

Linkoeping University1 site in 1 country170 target enrollmentJanuary 17, 2019
ConditionsLoneliness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Loneliness
Sponsor
Linkoeping University
Enrollment
170
Locations
1
Primary Endpoint
Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 17, 2019
End Date
February 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Gerhard Andersson

Professor

Linkoeping University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Study Sites (1)

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