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Completed

NCT Number: NCT03807154

Guided Online Self-help for Loneliness

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.

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Key information

Conditions

Loneliness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ICBT

Behavioral

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

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).

Primary outcomes

  1. 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

  1. Change on Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: 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.

  2. Change on Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  3. Change on Social Interaction Anxiety Scale (SIAS)

    Time frame: 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.

  4. Change on Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • University College, London

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2019
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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