Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems

Study Overview
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Brief Summary
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The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.

Detailed Description
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Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments. Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given. However, previous research has not taken the issue of comorbidity into account. It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile. By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT. We will also include a control group in the form of a supervised online discussion group who will later receive CBT.

Official Title
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Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems

Conditions
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Depression, Anxiety Disorders

Intervention / Treatment
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* Behavioral: Tailored Internet-delivered CBT
* Behavioral: Non-tailored Internet-delivered CBT
* Behavioral: Online discussion group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Major Depressive Disorder 15 or more on MADRS-S Exclusion Criteria: Severe depression (more than 35 on MADRS-S or based on interview) Severe psychiatric condition (e.g. psychosis or bipolar disorder) Changed medication during the last three months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Internet-delivered CBT<br> | Behavioral: Tailored Internet-delivered CBT<br>* This intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.<br>|
| Experimental: Non-tailored Internet-delivered CBT<br> | Behavioral: Non-tailored Internet-delivered CBT<br>* Specific text-based self-help for depression, which has previously been tested in three previous randomized trials. Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health.<br>|
| Active Comparator: Online discussion group<br> | Behavioral: Online discussion group<br>* Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) |  | One week before the treatment starts | 
| Beck Depression Inventory (BDI) |  | Five weeks after treatment started | 
| Beck Depression Inventory (BDI) |  | At treatment termination (10 weeks) | 
| Beck Depression Inventory (BDI) |  | 6 month after treatment ended | 
| Beck Depression Inventory (BDI) |  | 2 years after treatment ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory (BAI) |  | One week before the treatment starts | 
| Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) |  | One week before the treatment starts | 
| Quality of Life Inventory (QOLI) |  | One week before the treatment starts | 
| Beck Anxiety Inventory (BAI) |  | Five weeks after treatment started | 
| Beck Anxiety Inventory (BAI) |  | At treatment termination (10 weeks) | 
| Beck Anxiety Inventory (BAI) |  | 6 month after treatment ended | 
| Beck Anxiety Inventory (BAI) |  | 2 years after treatment ended | 
| Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) |  | Five weeks after treatment started | 
| Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) |  | At treatment termination (10 weeks) | 
| Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) |  | 6 month after treatment ended | 
| Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) |  | 2 years after treatment ended | 
| Quality of Life Inventory (QOLI) |  | Five weeks after treatment started | 
| Quality of Life Inventory (QOLI) |  | At treatment termination (10 weeks) | 
| Quality of Life Inventory (QOLI) |  | 6 month after treatment ended | 
| Quality of Life Inventory (QOLI) |  | 2 years after treatment ended |