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

Study Overview
=================
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.

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

Conditions
-----------------
Depressive Symptoms, Depressive Disorder, Major

Intervention / Treatment
-----------------
* Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Factor one: Regular therapist support by a therapist/On-demand guidance by a health care team (the participants themselves can choose to contact a physician, a nurse, a clinical psychologist, an IT-technician and/or the principal investigator of the study). Factor two: The content (the modules) is chosen by the participants themselves/The content is chosen by the therapist conducting the intake interview.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expert-chosen content, regular guidance<br>Content chosen by the therapist, weekly guidance by a therapist. | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)<br>* The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation). The fifteen modules are: Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention. The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview.<br>|
| Experimental: Expert-chosen content, on-demand guidance<br>Content chosen by the therapist, guidance upon request from the health care team. | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)<br>* The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation). The fifteen modules are: Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention. The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview.<br>|
| Experimental: Participant-chosen content, regular guidance<br>Content chosen by participants themselves, weekly guidance by a therapist. | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)<br>* The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation). The fifteen modules are: Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention. The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview.<br>|
| Experimental: Participant-chosen content, on-demand guidance<br>Content chosen by participants themselves, guidance upon request from the health care team. | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)<br>* The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation). The fifteen modules are: Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention. The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Becks Depression Inventory-II (BDI-II) | 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. | Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention. | 
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Insomnia Severity Index (ISI) | 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). | Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention. | 
| 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. | Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention. | 
| 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. | Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention. |