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Trial registered on ANZCTR


Registration number
ACTRN12607000655448
Ethics application status
Approved
Date submitted
6/12/2007
Date registered
21/12/2007
Date last updated
28/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chronic pain and post traumatic stress disorder (PTSD) in survivors of war and torture – efficacy of a biofeedback-based cognitive behavioral therapy (CBT): A randomized trial
Scientific title
The efficacy of CBT-biofeedback for traumatised refugees suffering from chronic pain
Secondary ID [1] 290234 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder and Chronic Pain 2606 0
Condition category
Condition code
Mental Health 2724 2724 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment protocol consists of 10 weekly sessions of 90 minutes within three months. Every session lasts 90 minutes each. In the initial sessions, the predominant physical and psychological problems as well as problems of the patient’s current life situation are discussed. Furthermore, psychoeducation is delivered and an individual model of the patient’s current complaints and possible ways to recovery is developed. In sessions three through nine, therapist and patient focus on the individual primary pain. Different relaxation strategies are introduced and trained with the help of CBT-BF. In addition, patients receive daily homework to exercise progressive muscle relaxation. In session nine, pain-related problems such as dysfunctional cognitions and behaviour, or inactivity are modified using standard CBT techniques. In session ten, the learned methods and strategies for coping with chronic pain are reviewed and evaluated regarding their use in future pain situations. Farewell at termination of treatment is included.
Intervention code [1] 2344 0
Treatment: Other
Comparator / control treatment
Individuals assigned to the waiting-list receive the same treatment after being reassessed after a period of 3 months waiting
Control group
Active

Outcomes
Primary outcome [1] 3617 0
verbal rating scale (VRS)
German Pain Coping Questionnaire (FESV)
Timepoint [1] 3617 0
only 3-months follow up
Primary outcome [2] 299763 0
Posttraumatic Diagnostic Scale (PDS)
Timepoint [2] 299763 0
pre, post, 3 months follow up
Secondary outcome [1] 6058 0
Psychophysiological stress-pain-assessment (electromyography (EMG), heart rate and the skin conductance)
Timepoint [1] 6058 0
only 3 months follow up,
no skin conductance
Secondary outcome [2] 328046 0
Hopkins Symptom Checklist (HSCL-25 anxiety)
Timepoint [2] 328046 0
pre, post 3 months follow up

Eligibility
Key inclusion criteria
Traumatic experience, chronic pain.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neuropathic pain, Current psychotic, bipolar, substance-related, or severe personality disorder
risk of psychosis, suicidal intentions, substance abuse, pronounces dissociative tendenicies, currently receiving pain-treatment elsewhere

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomized by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
8/05/2007
Date of last participant enrolment
Anticipated
Actual
29/05/2009
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
60
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 708 0
Germany
State/province [1] 708 0
Country [2] 709 0
Switzerland
State/province [2] 709 0

Funding & Sponsors
Funding source category [1] 2864 0
Charities/Societies/Foundations
Name [1] 2864 0
Stiftung Ueberleben
Country [1] 2864 0
Germany
Primary sponsor type
Individual
Name
Dr. Christine Knaevelsrud
Address
Treatment Center for Torture Victims
GSZ
Moabit Turmstrasse 21
10559 Berlin
Country
Germany
Secondary sponsor category [1] 2580 0
Individual
Name [1] 2580 0
Dr. Julia Mueller
Address [1] 2580 0
Department of Psychiatry
University Hospital Zurich
Culmannstrasse 8
8091 Zurich
Country [1] 2580 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4803 0
Charite Berlin
Ethics committee address [1] 4803 0
Ethics committee country [1] 4803 0
Germany
Date submitted for ethics approval [1] 4803 0
Approval date [1] 4803 0
05/05/2007
Ethics approval number [1] 4803 0

Summary
Brief summary
Background: Chronic pain and posttraumatic stress disorder (PTSD) are frequently seen in non-western refugees. Only few controlled trials have been reported on the efficacy of interventions addressing chronic pain and PTSD. No convincing treatment concepts exist so far. The present study want to examine the efficacy of a newly developed pain-focused short-term cognitive-behavioural biofeedback (CBT-BF) approach that addresses chronic pain in traumatised refugees.
Method: Traumatised refugees with chronic pain are allocated at random to ten sessions of a manualized CBT-Biofeedback (CBT-BF) approach conducted over 10 weeks period or a waiting list control group. We expect CBT-BF to be useful for traumatized migrants with primarily body-oriented illness concepts. We hypothesize that the intervention will significantly improve clinical symptoms of chronic pain. Furthermore, we expect improvements in secondary outcomes such as symptom levels of PTSD, anxiety and depression, psy-chophysiological and psychoneuroendocrinological markers of pain, namely elevated cortisol and Electromy-ogram (EMG) levels, and quality of life.
Conclusion: If CBT-BF proves to be an effective treatment for chronic pain in traumatised migrants, our results will lend support to the establishment of CBT-BF in this group of patients. From an economic perspective, this study could make a contribution towards savings in health expenditure as it may provide the basis for a selective and directed use of psychotherapeutic interventions in a population that is difficult to treat due to both their differing cultural backgrounds and the chronicity, severity and multimorbidity of their disorders.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28230 0
Prof Christine Knaevelsrud
Address 28230 0
Freie Universität Berlin
Habelschwerdter Allee 45
14195 Berlin
Country 28230 0
Germany
Phone 28230 0
+49 30 838 55736
Fax 28230 0
Email 28230 0
[email protected]
Contact person for public queries
Name 11387 0
Dr. Christine Knaevelsrud
Address 11387 0
Freie Universität Berlin
Habelschwerdter Allee 45
14195 Berlin
Country 11387 0
Germany
Phone 11387 0
+49 30 838 55736
Fax 11387 0
+49 (0)30 838-458472
Email 11387 0
[email protected]
Contact person for scientific queries
Name 2315 0
Dr. Christine Knaevelsrud
Address 2315 0
Freie Universität Berlin
Habelschwerdter Allee 45
14195 Berlin
Country 2315 0
Germany
Phone 2315 0
+49 30 838 55736
Fax 2315 0
+49 (0)30 838-458472
Email 2315 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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