Post-Traumatic Stress DisorderPhase 4NCT00917397
The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants
A Phase 4 study testing Sertraline and trauma-focused cognitive behavioural therapy in people with Post-Traumatic Stress Disorder, run by Caecilie Buhmann at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Sertraline and trauma-focused cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Apr 2014
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult traumatised refugee with PTSD
Who cannot join
- psychosis and drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial
The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Sertraline, trauma-focused cognitive behavioural therapy
- Keywords
- Traumatized refugee, treatment, antidepressants, psychotherapy, PTSD in traumatized refugees
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
varies
trauma-focused cognitive behavioural therapyBehavioural
once a week
| Study group | Role | What they receive |
|---|---|---|
| psychotherapy | Experimental | Trauma-focused cognitive behavioral therapy Receives: Behavioral: trauma-focused cognitive behavioural therapy |
| Drug | Experimental | drug treatment and psychoeducation Receives: Drug: Sertraline |
| Waiting list | No intervention | subjects randomized to waiting list |
| Combination | Experimental | Both drug and psychotherapy Receives: Drug: Sertraline; Behavioral: trauma-focused cognitive behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Harvard Traume Questionnaire (PTSD)
Measured: before entry, after 6 months treatment and at follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caecilie Buhmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caecilie Buhmann, Psykiatrisk Center Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917397
- Sponsor's protocol ID
- PTF1
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2009
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. Long-term treatment effect of trauma-affected refugees with flexible cognitive behavioural therapy and antidepressants. Psychiatry Res. 2018 Jun;264:217-223. doi: 10.1016/j.psychres.2018.03.069. Epub 2018 Apr 4.
PubMed 29655114Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. Br J Psychiatry. 2016 Mar;208(3):252-9. doi: 10.1192/bjp.bp.114.150961. Epub 2015 Nov 5.
PubMed 26541687
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00917397
- Acronym / sponsor ID
- PTF1
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Traumatized refugee, treatment, antidepressants, psychotherapy, PTSD in traumatized refugees
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Caecilie BuhmannUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jun 2009 (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 purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| psychotherapy | Experimental | Behavioral: trauma-focused cognitive behavioural therapyTrauma-focused cognitive behavioral therapy |
| Drug | Experimental | Drug: Sertralinedrug treatment and psychoeducation |
| Waiting list | No intervention | –subjects randomized to waiting list |
| Combination | Experimental | Drug: Sertraline, Behavioral: trauma-focused cognitive behavioural therapyBoth drug and psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult traumatised refugee with PTSD
Key exclusion criteria (1 listed)
- psychosis and drug abuse
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 |
|---|---|---|
| Sertralinevaries | Drug | Combination, Drug |
| trauma-focused cognitive behavioural therapyonce a week | Behavioural | Combination, psychotherapy |
Primary outcome
Score on Harvard Traume Questionnaire (PTSD)
Time frame: before entry, after 6 months treatment and at follow up
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 18 Jun 2014.
- Derived from this study: PubMed 29655114Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. Long-term treatment effect of trauma-affected refugees with flexible cognitive behavioural therapy and antidepressants. Psychiatry Res. 2018 Jun;264:217-223. doi: 10.1016/j.psychres.2018.03.069. Epub 2018 Apr 4.
- Derived from this study: PubMed 26541687Buhmann CB, Nordentoft M, Ekstroem M, Carlsson J, Mortensen EL. The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. Br J Psychiatry. 2016 Mar;208(3):252-9. doi: 10.1192/bjp.bp.114.150961. Epub 2015 Nov 5.
Related trials for Post-Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline and trauma-focused cognitive behavioural therapy in people with Post-Traumatic Stress Disorder, run by Caecilie Buhmann 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 1 inclusion and 1 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 18 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Score on Harvard Traume Questionnaire (PTSD) (time frame: before entry, after 6 months treatment and at follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917397, which also lists 2 linked publications.
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 18 Jun 2014.