iCBT for Depression - Standard Versus Condensed Treatment Material

Study Overview
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Brief Summary
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Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. The investigators are not aware of any research that has investigated if slow readers, or persons with difficulty concentrating, can use the standard material or if they would benefit more from using an adapted version. In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment. Patients will be recruited within Örebro County by referrals and self-referrals. The goal is to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks and all patients will be assessed for depression at an interview with a psychologist. There will also be interviews after treatment and one year after treatment. The most important outcome will be depressive symptoms.

Official Title
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Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version

Conditions
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Major Depression

Intervention / Treatment
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* Behavioral: Standard internet-based cognitive behavior therapy
* Behavioral: Condensed internet-based cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fullfill criteria for diagnosis of major depression Being able to read and write Swedish Have access to the internet Being a resident in Örebro county Exclusion Criteria: Severe depressive symptoms (>34 on the MADRS-S) High risk for suicide Attending cognitive behavior therapy Psychosis Bipolar disorder Addiction to alcohol or illegal drugs A somatic or psychiatric condition that is a contraindication for iCBT or in some way debars iCBT, or have to be treated before depression

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard internet-based cognitive behavior therapy<br>Standard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only). | Behavioral: Standard internet-based cognitive behavior therapy<br>* Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention<br>* Other names: Standard iCBT;|
| Experimental: Condensed internet-based cognitive behavior therapy<br>Condensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio). | Behavioral: Condensed internet-based cognitive behavior therapy<br>* Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention<br>* Other names: Condensed iCBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms at post-treatment and after 12 months | Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated. | At baseline, after 12 weeks, after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diagnostic status for Major depression | The diagnostic status (depression) will be assessed in a face-to-face interview using the structured material Mini-International Neuropsychiatric Interview (M.I.N.I.). | Pre-treatment, after 12 weeks and after 1 year | 
| Change from baseline in symptoms of anxiety | Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI) | Pre-treatment, after 12 weeks and after 1 year | 
| Post-treatment treatment satisfaction | Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ) | After 12 weeks | 
| Therapist time | Therapist time will be measured automatically by the IT-platform and assesses the time spent on each patient by each therapist. A mean time will be calculated to report an estimated time needed to treat one patient with the two interventions. | Post treatment | 
| Alcohol use | To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment. | Pre treatment | 
| Drug use | To assess drug use the DUDIT-questionnaire will be filled out at pre treatment. | Pre treatment | 
| Treatment satisfaction at follow up | Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ) | After 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Internet, Cognitive Behavior Therapy