Internetbased Relapse Prevention for Partially Remitted Depression

NCT ID: NCT01807988

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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iCBT

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

Group Type EXPERIMENTAL

iCBT

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Örebro County Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fredrik Holländare

Clinical Psychologist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Psychiatric Research Centre

Örebro, , Sweden

Site Status NOT_YET_RECRUITING

Psychiatric Clinic in Uppsala

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Fredrik Holländare, PhD

Role: CONTACT

+46737600700

Facility Contacts

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Fredrik Holländare, PhD

Role: primary

+46737600700

Lisa Ekselius, PhD

Role: primary

Other Identifiers

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2012/488

Identifier Type: -

Identifier Source: org_study_id

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