Clinical trial NCT03807154: Guided Online Self-help for Loneliness
Official title: SOLUS - A Randomized Controlled Two-site Trial Comparing Internet-based Cognitive Behavioral Therapy and Internet-based Interpersonal Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Keywords: Loneliness
ICBT
Internet-based psychotherapy
Cognitive behavioral therapy
Interpersonal psychotherapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University College, London
First posted: 2019-01-16
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)
timeFrame: 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:
measure: Change on Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: 10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up
measure: Change on Patient Health Questionnaire (PHQ-9)
timeFrame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
measure: Change on Social Interaction Anxiety Scale (SIAS)
timeFrame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
measure: Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.