Internetbased Relapse Prevention for Partially Remitted Depression (ISAK)

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

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 Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: iCBT

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Psychiatric Clinic in Uppsala
    • Contact: Lisa Ekselius, PhD; Email: Lisa.Ekselius@neuro.uu.se
  • Örebro, Sweden, 70116
    • Not yet recruiting
    • Psychiatric Research Centre
    • Contact: Fredrik Holländare, PhD; Phone Number: +46737600700; Email: fredrik.hollandare@orebroll.se
    • Principal Investigator: Fredrik Holländare, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCBT; Internetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression.	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.
No Intervention: Control group; The control group in the study will fill out questionnaires every month and will be interviewed every month to detect any relapses. They will also receive feedback on there self-reported symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Örebro County Council
• Collaborators: Uppsala University; Uppsala County Council, Sweden

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Estimate): January 23, 2014
• Last Update Submitted That Met QC Criteria: January 22, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Relapse, Recurrence, Depression, Internet, Sick-leave
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Disease Attributes; Depression; Depressive Disorder; Recurrence
• Other Study ID Numbers: 2012/488