Depression
Conditions
Keywords
Relapse, Recurrence, Depression, Internet, Sick-leave
Brief summary
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.
Interventions
BEHAVIORALiCBT
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.
Sponsors
Uppsala University
Uppsala County Council, Sweden
Örebro County Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days absent from work due to sick leave | 24 month follow up | 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. |
| Change in self-reported sick leave days | 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 | 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. |
| Change in diagnostic status | 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 (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. |
| Change in depressive symptoms | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in health related quality of life | 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 | Health related quality of life will be measured by an internetbased version of the EQ-5D. The questionnaire will be filled out every month. |
| Change in costs associated with illness | Pre- and post treatment, after 12 and 24 months | 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). |
Countries
Sweden
Contacts
Primary ContactFredrik Holländare, PhD
Outcome results
None listed