Traumatized Refugees -Stress Management Versus Cognitive... | NCT01362543

Studies
Traumatized Refugees -Stress Management Versus Cognitive Re-structuring

NCT01362543

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Status

Completed

Last Update Posted

May 14, 2014Estimated

Enrollment

143Actual

Phase

Phase 3

Conditions

Posttraumatic Stress Disorder

Interventions

Cognitive behavioural therapy (stress management)
Cognitive Behavioural Therapy (cognitive restructuring)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 24, 2011

First Submission Date that Met QC Criteria

May 27, 2011

First Posted Date

May 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2014

Last Update Posted Date

May 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jessica Carlsson Lohmann, M.D., Phd, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalPrincipal Investigator

Lead Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalOTHER

Collaborators

Name	Class
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress Management	Active Comparator		Other: Cognitive behavioural therapy (stress management)
Cognitive restructuring	Active Comparator		Other: Cognitive Behavioural Therapy (cognitive restructuring)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive behavioural therapy (stress management)	Other	Following a manual	Stress Management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jessica M Carlsson Lohmann, MD, PhD	Competence Centre for Transcultural Psychiatry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Competence Centre for Transcultural Psychiatry		Ballerup Municipality		2750	Denmark

References Module

Citations

Not provided

ID	Term
D013313	Stress Disorders, Post-Traumatic
D003863	Depression
D014947	Wounds and Injuries

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D015928	Cognitive Behavioral Therapy
D000088686	Cognitive Restructuring

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities