Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help

Study Overview
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Brief Summary
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The study is a randomized controlled trial and to compare the benefits of a 10-week web-based unguided self-help treatment with the same intervention complemented with weekly therapist support via e-mail. A waiting-list control group will be included. The Beck Depression Inventory (BDI-II) will be used as the primary outcome measure. Secondary outcomes include general psychopathology, interpersonal problems, and quality of life.

Detailed Description
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Depression is a major health problem associated with significant disability and economic costs. Although depression can be treated effectively with several psychological and pharmacological treatment options, many sufferers still seek or receive inadequate therapy or no therapy at all. Internet-based treatments may help to serve this demand, being accessible anytime and anywhere making it easier for underserved populations and people living in remote areas to receive treatment. The present study aims to assess the efficacy of an internet-based CBT intervention for depression (Deprexis), directly comparing the benefits of a low intensity therapist-guided with an unguided self-help version. A waiting-list control group will be included. Individuals meeting the diagnostic criteria of major depression or dysthymia will be randomly assigned to one of the three conditions. While unguided self-help will not include any contact with a therapist or the study team during the treatment, guided self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility to ask questions via e-mail. While in an earlier study Deprexis was assessed as an add-on to TAU, this study will examine the efficacy of the program when delivered as a stand-alone intervention (i.e., only individuals who currently do not receive psychotherapy will be included). Moreover, this study will include a structured diagnostic interview at pretreatment. Only participants fulfilling the criteria of a depressive disorder (major depression or dysthymia) will be included in the trial. Participants will be recruited in Switzerland and Germany via articles in national and regional newspapers and a national television interview. All questionnaires will be administered via the internet. The 21-item BDI-II will be used as the main outcome measure. Secondary outcome measures will include the Brief Symptom Inventory (53-item BSI), the Inventory of Interpersonal Problems (64-item IIP), and the WHOQOL-BREF.

Official Title
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Internet-Based Treatment of Depression: A Randomized Controlled Trial Comparing Guided With Unguided Self-Help

Conditions
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Depression

Intervention / Treatment
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* Device: Deprexis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: access to the internet informed consent to participate BDI-II score > 13 if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior and during study Exclusion Criteria: suicide item of BDI ≥ 2 other psychological treatment during this study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deprexis (unguided)<br>web-based self-help program without any support from a therapist during the 10-week treatment period | Device: Deprexis<br>* CBT-based, integrative online self-help program<br>|
| Experimental: Deprexis (guided, with therapist)<br>web-based self-help program plus scheduled e-mail contact with a therapist during the 10-week treatment period | Device: Deprexis<br>* CBT-based, integrative online self-help program<br>|
| No Intervention: Wait-list<br>Wait-list group (subjects receive access to Deprexis after 10 weeks) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory - II (BDI-II) | Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory (53-item BSI) | Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology). | 10 weeks | 
| Inventory of Interpersonal Problems (IIP) | Self-report measure of interpersonal problems; total score computed as the mean across all items; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology) | 10 weeks | 
| WHOQOL-BREF | Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life. | 10 weeks |