Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

NCT ID: NCT01362543

Last Updated: 2014-05-14

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

Brief Summary

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The Competence Centre for Transcultural Psychiatry is a clinic specialised in the treatment of traumatised refugees. There is a lack of studies on treatment effect in traumatised refugees. There are several studies indicating an effect of cognitive behavioural therapy (CBT) in Posttraumatic Stress Disorder (PTSD). A few studies point to that CBT could be effective in traumatised refugees. There are no studies examining if some methods used in CBT are more useful than others in traumatised refugees. The aim of this study is to examine the effect of CBT with focus on Stress Management versus cognitive restructuring. Patients included in this study will be randomised to either Stress Management or cognitive restructuring. All referred patients will receive medical treatment as usual (described in the clinic's manual for medical doctors, 2011). All patients that fulfill the inclusion criteria will be included in the study. Hopefully this study will contribute to improve the psychotherapeutic treatment offered to traumatised refugees.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stress Management

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy (stress management)

Intervention Type OTHER

Following a manual

Cognitive restructuring

Group Type ACTIVE_COMPARATOR

Cognitive Behavioural Therapy (cognitive restructuring)

Intervention Type OTHER

Following a manual

Interventions

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Cognitive behavioural therapy (stress management)

Following a manual

Intervention Type OTHER

Cognitive Behavioural Therapy (cognitive restructuring)

Following a manual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Refugee or patient that has been reunified with family member being a refugee.
* Symptoms of PTSD in accordance with International Classification of Diseases-10 (ICD-10) research criteria.
* Trauma in the past such as imprisonment, torture (according to UN definition), war experiences.
* Referred by a medical doctor.
* Motivated for treatment.
* Informed consent.

Exclusion Criteria

* Severe psychotic illness such as schizophrenia or bipolar disorder
* Drug abuse
* Patients admitted to in ward treatment
* No informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Jessica Carlsson Lohmann

M.D., Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica M Carlsson Lohmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Competence Centre for Transcultural Psychiatry

Locations

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Competence Centre for Transcultural Psychiatry

Ballerup Municipality, , Denmark

Site Status

Countries

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Denmark

Related Links

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Other Identifiers

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PTF2

Identifier Type: -

Identifier Source: org_study_id

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