Guided Online Self-help for Loneliness

NCT03807154 | Completed

• 1 other identifier: SOLUS
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (3)

Internet-based cognitive behavioral therapy (ICBT)

EXPERIMENTAL

A nine-week long ICBT intervention with therapist support.

Behavioral: ICBT

Internet-based Interpersonal Therapy (IIPT)

EXPERIMENTAL

A nine-week long intervention based in interpersonal psychotherapy with therapist support.

Behavioral: IPT

Wait-list

NO INTERVENTION

Wait-list control group

Interventions

ICBT BEHAVIORAL

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

Internet-based cognitive behavioral therapy (ICBT)

IPT BEHAVIORAL

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).

Internet-based Interpersonal Therapy (IIPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Linkoeping University: lead
• University College, London: collaborator

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34182552 DERIVED

Study Officials

• Gerhard Andersson, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 16, 2019
• Study Start: January 17, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)