Internetbased Relapse Prevention for Partially Remitted Depression

Depression Clinical Trial

— ISAK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01807988
• Other study ID #: 2012/488
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2013
• Last updated: January 22, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Örebro County Council
• Contact: Fredrik Holländare, PhD
• Phone: +46737600700
• Email: fredrik.hollandare[@]orebroll.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• iCBT
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.

Locations

Country	Name	City	State
Sweden	Psychiatric Research Centre	Örebro
Sweden	Psychiatric Clinic in Uppsala	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Örebro County Council	Uppsala County Council, Sweden, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No