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Internetbased Relapse Prevention for Partially Remitted Depression (ISAK)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
iCBT
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Relapse, Recurrence, Depression, Internet, Sick-leave

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Clinic in UppsalaRecruiting
  • Psychiatric Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCBT

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 6, 2013
Last Updated
January 22, 2014
Sponsor
Örebro County Council
Collaborators
Uppsala University, Uppsala County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01807988
Brief Title
Internetbased Relapse Prevention for Partially Remitted Depression
Acronym
ISAK
Official Title
Regional Study of Internet-based Relapse Prevention as an Adjunct to Partially Successful Antidepressant Medication
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Uppsala University, Uppsala County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Relapse, Recurrence, Depression, Internet, Sick-leave

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCBT
Arm Type
Experimental
Arm Description
Internetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iCBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days absent from work due to sick leave
Description
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.
Time Frame
24 month follow up
Title
Change in self-reported sick leave days
Description
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.
Time Frame
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
Title
Change in diagnostic status
Description
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.
Time Frame
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
Title
Change in depressive symptoms
Description
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.
Time Frame
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 Measure Information:
Title
Change in health related quality of life
Description
Health related quality of life will be measured by an internetbased version of the EQ-5D. The questionnaire will be filled out every month.
Time Frame
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
Title
Change in costs associated with illness
Description
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).
Time Frame
Pre- and post treatment, after 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Holländare, PhD
Phone
+46737600700
Email
fredrik.hollandare@orebroll.se
Facility Information:
Facility Name
Psychiatric Clinic in Uppsala
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Ekselius, PhD
Email
Lisa.Ekselius@neuro.uu.se
Facility Name
Psychiatric Research Centre
City
Örebro
ZIP/Postal Code
70116
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Holländare, PhD
Phone
+46737600700
Email
fredrik.hollandare@orebroll.se
First Name & Middle Initial & Last Name & Degree
Fredrik Holländare, PhD

12. IPD Sharing Statement

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Internetbased Relapse Prevention for Partially Remitted Depression

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