Guided Online Self-help for Loneliness

Study Overview
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Brief Summary
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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.

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

Conditions
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Loneliness

Intervention / Treatment
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* Behavioral: ICBT
* Behavioral: IPT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based cognitive behavioral therapy (ICBT)<br>A nine-week long ICBT intervention with therapist support. | Behavioral: ICBT<br>* A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.<br>|
| Experimental: Internet-based Interpersonal Therapy (IIPT)<br>A nine-week long intervention based in interpersonal psychotherapy with therapist support. | Behavioral: IPT<br>* 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).<br>|
| No Intervention: Wait-list<br>Wait-list control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loneliness, ICBT, Internet-based psychotherapy, Cognitive behavioral therapy, Interpersonal psychotherapy