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Biofeedback breathing regulation during exposure in patients with PTSD

Biofeedback breathing regulation during exposure in patients with PTSD - Biofeedback during exposure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32976
Enrollment
20
Registered
2009-11-24
Start date
2010-01-05
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

PTSD and stress disorder

Interventions

Patients will be randomized to regular TF-CBT (n = 10) or to TF-CBT + biofeedback (n = 10). The latter group will receive breathing biofeedback during all exposure sessions within the TF-CBT treatme

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: CAPS score of * 50 Male and female, aged 18 years and above Written informed consent Eligible for exposure therapy Right handed

Exclusion criteria

Exclusion criteria: Suicidal risk Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, depression with psychotic features, a panic disorder with or without agoraphobia or excessive substance related disorder over the past 6 months Primary diagnosis of severe depressive disorder Presence of primary or co-morbid personality disorder An organic disorder Taking any psychotropic medications at present

Design outcomes

Primary

MeasureTime frame
The acute effects of additive biofeedback will be assessed by measuring change in: breathing frequency, heart rate (HR), heart rate variability (HRV), saliva cortisol levels during exposure sessions, and the change on the Subjective Units of Distress (SUDS) during the sessions as well as the change on the Impact of Event Scale-Revised (IES-R) from session to session. Secondary parameters are anxiety and depression rates on the Hospital Anxiety and Depression scale (HADS) from baseline to 1 week post-treatment.

Secondary

MeasureTime frame
not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)