ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content

Not Applicable

Completed

• Conditions: Depressive Symptoms; Depressive Disorder, Major
• Interventions: Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

• Registration Number: NCT04260750
• Lead Sponsor: Linkoeping University

Brief Summary

The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.

Detailed Description

The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.

Study Timeline

• Study Start: 2020-01-13
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Status Verified: 2021-04
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
• 18 years or older.
• Adequate ability to understand and speak Swedish.
• Access to the internet and a smartphone/computer.

Exclusion Criteria

• Other ongoing psychological treatment or counselling.
• Recent (within the past 3 months) changes in the dose of psychotropic medication.
• Prior diagnosis of psychosis, bipolar disorder, or substance dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Participant-chosen content, on-demand guidance	Internet-administered Cognitive behavioral therapy (ICBT)	Content chosen by participants themselves, guidance upon request from the health care team.
Expert-chosen content, regular guidance	Internet-administered Cognitive behavioral therapy (ICBT)	Content chosen by the therapist, weekly guidance by a therapist.
Expert-chosen content, on-demand guidance	Internet-administered Cognitive behavioral therapy (ICBT)	Content chosen by the therapist, guidance upon request from the health care team.
Participant-chosen content, regular guidance	Internet-administered Cognitive behavioral therapy (ICBT)	Content chosen by participants themselves, weekly guidance by a therapist.

Primary Outcome Measures

Name	Time	Method
Change on Patient Health Questionnaire (PHQ-9)	Baseline, during week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of the intervention, post-intervention (after 11 weeks), 12 months after the end of intervention.	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.
Change on Becks Depression Inventory-II (BDI-II)	Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.	Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.

Secondary Outcome Measures

Name	Time	Method
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)	Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.	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.
Change on Brunnsviken Brief Quality of Life Scale (BBQ)	Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.	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.
Change on Insomnia Severity Index (ISI)	Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.	Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia). Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).

Trial Locations

Locations (1)

Linköping University; 🇸🇪 Linköping, Östergötland, Sweden