Suspended

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

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What is being tested

iCBT

Behavioral
Who is being recruted

Behavior+4

+ Behavioral Symptoms

+ Pathologic Processes

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorÖrebro County Council
Study ContactFredrik Holländare, PhDMore contacts
Last updated: January 23, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01807988
Principal SponsorÖrebro County Council
Study ContactFredrik Holländare, PhDMore contacts
Last updated: January 23, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

264 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesDepressionRecurrence

Criteria

6 inclusion criteria required to participate
A history of at least one episode of Major Depression
Being able to read and write Swedish
Currently in (at least) half-time employment, self-employment or education
Having access to the internet
Show More Criteria
4 exclusion criteria prevent from participating
Fulfilling the criteria for Major depression
Psychosis
Substance abuse
Suicidality

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

No Intervention
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Psychiatric Clinic in Uppsala

Uppsala, SwedenOpen Psychiatric Clinic in Uppsala in Google Maps
Recruiting soon

Psychiatric Research Centre

Örebro, Sweden
Suspended2 Study Centers