Internetbased Relapse Prevention for Partially Remitted Depression

Study Overview
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Brief Summary
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The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. We hypothesise that during the two years following the intervention: The persons in the group receiving Internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group. Fewer persons in the group receiving Internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group. The persons in the group receiving Internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group. At follow-up, the persons in the group receiving Internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.

Official Title
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Regional Study of Internet-based Relapse Prevention as an Adjunct to Partially Successful Antidepressant Medication

Conditions
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Depression

Intervention / Treatment
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* Behavioral: iCBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild residual depressive symptoms (7-19 on the MADRS-S). A history of at least one episode of Major Depression. Currently in (at least) half-time employment, self-employment or education. Taking a stable (since one month) and therapeutic dosage of antidepressant medication Being able to read and write Swedish Having access to the internet Exclusion Criteria: Fulfilling the criteria for Major depression Psychosis Substance abuse Suicidality

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCBT<br>Internetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression. | Behavioral: iCBT<br>* Internetbased cognitive behavior therapy (iCBT) contains interventions that will help the participant to change her behavior to experience more positive reinforcement in daily life and also to challenge her negative patterns of thought. There are also information and exercices to improve sleep, increase physical activity, train mindfulness, handle anxiety and to learn about depression.<br>|
| No Intervention: Control group<br>The control group in the study will fill out questionnaires every month and will be interviewed every month to detect any relapses. They will also receive feedback on there self-reported symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days absent from work due to sick leave | The total number of days that a participant has been absent from work due to sick leave (any cause). Data will be collected from the National Insurance Agency at the end of the study. | 24 month follow up | 
| Change in self-reported sick leave days | Self-reported number of sick leave days during the study will be collected cumulatively every month during the study time and summarised after 24 months. | After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months | 
| Change in diagnostic status | Change in diagnostic status (depressive relapse) will be assessed in a telephone interview every month during the study. The definition of a relapse is to fulfill the diagnostic criteria for major depression according to the DSM-IV at any time after the study start. | After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months | 
| Change in depressive symptoms | Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. The patient will fill out the questionnaire every month. | After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health related quality of life | Health related quality of life will be measured by an internetbased version of the EQ-5D. The questionnaire will be filled out every month. | After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months | 
| Change in costs associated with illness | Change in costs will be measured by an internetbased version of the self-assessment scale Trimbos/iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P). | Pre- and post treatment, after 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse, Recurrence, Depression, Internet, Sick-leave