Internetbased Relapse Prevention for Partially Remitted Depression

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: iCBT

• Registration Number: NCT01807988
• Lead Sponsor: Örebro County Council

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Study Start: 2013-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCBT	iCBT	Internetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Psychiatric Clinic in Uppsala; 🇸🇪 Uppsala, Sweden

Psychiatric Research Centre; 🇸🇪 Örebro, Sweden