Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

NCT01362543 | Completed Phase 3 DMC

• 1 other identifier: PTF2
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; Depression; Refugees; Trauma

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)

  Baseline, after 2 months and after 6 months

Secondary Outcomes (5)

• Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items

  Baseline, after 2 months and after 6 months

• Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items

  Baseline, after 2 months and after 6 months

• Change in quality of life measured by the WHO-5

  Baseline, after 2 months and 6 months

• Changes in functioning measured by the the Sheehan Disability Scale (SDS)

  Baseline, after 2 months and 6 months

• Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)

  After 6 months

Study Arms (2)

Stress Management

ACTIVE COMPARATOR

Other: Cognitive behavioural therapy (stress management)

Cognitive restructuring

ACTIVE COMPARATOR

Other: Cognitive Behavioural Therapy (cognitive restructuring)

Interventions

Cognitive behavioural therapy (stress management) OTHER

Following a manual

Stress Management

Cognitive Behavioural Therapy (cognitive restructuring) OTHER

Following a manual

Cognitive restructuring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Competence Centre for Transcultural Psychiatry

Ballerup Municipality, 2750, Denmark

Location

Related Links

• Link to web page of the Competence Centre for Transcultural Psychiatry (mostly in Danish)

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Wounds and Injuries

Interventions

Cognitive Behavioral Therapy; Cognitive Restructuring

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica M Carlsson Lohmann, MD, PhD

  Competence Centre for Transcultural Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Phd

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 30, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

DK (1)