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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
264
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.
Psychiatric Research Centre
Örebro, Sweden
NOT_YET_RECRUITINGPsychiatric Clinic in Uppsala
Uppsala, Sweden
RECRUITINGDays 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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).
Time frame: Pre- and post treatment, after 12 and 24 months
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