Posttraumatic Stress DisorderPhase 3NCT01362543
Traumatized Refugees -Stress Management Versus Cognitive Re-structuring
A Phase 3 study testing Cognitive behavioural therapy (stress management) and Cognitive Behavioural Therapy (cognitive restructuring) in people with Posttraumatic Stress Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Cognitive behavioural therapy (stress management) and Cognitive Behavioural Therapy (cognitive restructuring)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe psychotic illness such as schizophrenia or bipolar disorder
- Drug abuse
- Patients admitted to in ward treatment
- No informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Competence Centre for Transcultural Psychiatry
Ballerup Municipality, 2750
About this study
Official title: Treatment With Cognitive Behavioural Therapy in Traumatised Refugees - Stress Management Versus Cognitive Restructuring - a Randomised Clinical Trial
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
- Being tested
- Cognitive behavioural therapy (stress management), Cognitive Behavioural Therapy (cognitive restructuring)
- Keywords
- PTSD, Depression, Refugees, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy (stress management)Other
Following a manual
Cognitive Behavioural Therapy (cognitive restructuring)Other
Following a manual
| Study group | Role | What they receive |
|---|---|---|
| Stress Management | Active comparator | Not described Receives: Other: Cognitive behavioural therapy (stress management) |
| Cognitive restructuring | Active comparator | Not described Receives: Other: Cognitive Behavioural Therapy (cognitive restructuring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)
Measured: 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
Measured: Baseline, after 2 months and after 6 months
Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items
Measured: Baseline, after 2 months and after 6 months
Change in quality of life measured by the WHO-5
Measured: Baseline, after 2 months and 6 months
Changes in functioning measured by the the Sheehan Disability Scale (SDS)
Measured: Baseline, after 2 months and 6 months
Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Jessica Carlsson Lohmann, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Jessica M Carlsson Lohmann, MD, PhD, Principal investigator, Competence Centre for Transcultural Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362543
- Sponsor's protocol ID
- PTF2
- Status last verified
- May 2014
- First submitted
- 24 May 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Cognitive Behavioural Therapy in Traumatised Refugees - Stress Management Versus Cognitive Restructuring - a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01362543
- Acronym / sponsor ID
- PTF2
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Depression, Refugees, Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Management | Active comparator | Other: Cognitive behavioural therapy (stress management) |
| Cognitive restructuring | Active comparator | Other: Cognitive Behavioural Therapy (cognitive restructuring) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Severe psychotic illness such as schizophrenia or bipolar disorder
- Drug abuse
- Patients admitted to in ward treatment
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy (stress management)Following a manual | Other | Stress Management |
| Cognitive Behavioural Therapy (cognitive restructuring)Following a manual | Other | Cognitive restructuring |
Primary outcome
Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ)
Time frame: Baseline, after 2 months and after 6 months
5 secondary outcomes
Change in depressive symptoms measured by the Hopkins Symptoms Checklist-25 (HSCL-25), depressive items
Time frame: Baseline, after 2 months and after 6 months
Change in anxiety symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25), anxiety items
Time frame: Baseline, after 2 months and after 6 months
Change in quality of life measured by the WHO-5
Time frame: Baseline, after 2 months and 6 months
Changes in functioning measured by the the Sheehan Disability Scale (SDS)
Time frame: Baseline, after 2 months and 6 months
Achievement of goals set at beginning of psychotherapy using Goal Attainment Scaling (GAS)
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
- Link to web page of the Competence Centre for Transcultural Psychiatry (mostly in Danish)Link provided by the sponsor.
Related trials for Posttraumatic Stress Disorder
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
RecruitingPhase 3
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Post Traumatic Stress Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica M Carlsson Lohmann, MD, PhD principal investigator
Competence Centre for Transcultural Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive behavioural therapy (stress management) and Cognitive Behavioural Therapy (cognitive restructuring) in people with Posttraumatic Stress Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire (HTQ) (time frame: Baseline, after 2 months and after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.