Clinical trial NCT01807988: Internetbased Relapse Prevention for Partially Remitted Depression
Official title: Regional Study of Internet-based Relapse Prevention as an Adjunct to Partially Successful Antidepressant Medication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Relapse, Recurrence, Depression, Internet, Sick-leave
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala University
name: Uppsala County Council, Sweden
First posted: 2013-03-08
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Days absent from work due to sick leave
timeFrame: 24 month follow up
measure: Change in self-reported sick leave days
timeFrame: 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
measure: Change in diagnostic status
timeFrame: 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
measure: Change in depressive symptoms
timeFrame: 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 outcomes:
measure: Change in health related quality of life
timeFrame: 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
measure: Change in costs associated with illness
timeFrame: Pre- and post treatment, after 12 and 24 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Psychiatric Clinic in Uppsala
city: Örebro
country: Sweden
facility: Psychiatric Research Centre
Study officials:
References: