Randomized Trial of Depression Follow-up Care by Email

Study Overview
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Brief Summary
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The primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.

Detailed Description
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Depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease. Although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase. Therefore options of follow-up care have to be considered. Since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.

Official Title
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Randomized Trial of E-mail Follow-up Care After Cognitive Behavioural Treatment for Depression

Conditions
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Depressive Disorders

Intervention / Treatment
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* Behavioral: E-mail follow up care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depressive disorder: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10 Precursory CBT Internet access Exclusion Criteria: No knowledge of the German language Risk of suicide Acute psychosis or psychotic symptoms Established concurrent in vivo CBT after discharge from inpatient CBT

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: E-mail follow up care<br>After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week). The follow up care aims at supporting the patients in continuing exercises they have learned during the initial treatment phase in order to cope with depression, e.g. integrating positive activities in their all day life or monitoring the interdependence of cognition, emotion and behaviour. | Behavioral: E-mail follow up care<br>* After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week). The follow up care aims at supporting the patients in continuing exercises in order to cope with depression.<br>* Other names: web based psychotherapy;|
| No Intervention: Treatment as usual<br>After having terminated inpatient CBT patients receive treatment as usual within routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the severity of depression - Beck Depression Inventory (BDI- II) |  | Change in the BDI-II from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of health related quality of life - SF-8 | SF-8: short version of the SF -36 | Change in the SF-8 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care | 
| GAD-7 | Measure for generalized anxiety disorder | Change in the GAD-7 from baseline (beginning of treatment) to follow up (3 months after termination of the follow-up care) | 
| Depressive relapse/recurrence |  | Measured at follow up (3 months after termination of the follow-up care) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow up care, e-mail, effectiveness, depressive disorders