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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

The efficacy of CBT-biofeedback for traumatised refugees suffering from chronic pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000655448
Enrollment
34
Registered
2007-12-21
Start date
2007-05-08
Completion date
2009-05-29
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 individua

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.

Sponsors

Dr. Christine Knaevelsrud
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Traumatic experience, chronic pain.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026