Biofeedback breathing regulation during exposure in patients with PTSD

Posttraumatic Stress Disorder (PTSD) has a major health and economic burden on
patients, their relatives and society as a whole. It is therefore important to
have optimal treatment available for this disorder. Trauma focused cognitive
behavioural therapy (TF-CBT) has been found to be the most effective
psychotherapeutic treatment, with imaginal exposure as its key ingredient.
Nevertheless, not every patient fully recovers with TF-CBT and often several
exposure sessions are needed to reduce the PTSD symptoms. Based on recent
pilot-studies showing that biofeedback induces changes in the parasympathetic
nervous system and reduces anxiety and depression rates, we expect biofeedback
to be a good complementary component to imaginal exposure conducted during
TF-CBT treatment. We hypothesize that it induces acute changes in psycho
physiological arousal and subjective distress and accordingly fastens the
reduction of the core PTSD symptoms and accompanying anxiety and depression
symptoms.

The main objective of this study is to assess whether treatment of PTSD with
TF-CBT can be more effective and efficient by adding breathing biofeedback to
the exposure sessions. We hypothesize that adding breathing biofeedback to
exposure in TF-CBT produces acute changes in physiological reactivity (e.g.,
increase in heart rate variability (HRV)) and fastens the reduction of
PTSD-symptom levels compared to exposure in a TF-CBT condition without any
adjunctive intervention. Secondary, we assess and compare the reduction of
anxiety and depression scores of both TF-CBT conditions (TF-CBT + biofeedback
vs. TF-CBT alone).

In this pilot study a comparison between PTSD patients (N = 20) randomised to
either regular TF-CBT treatment (N = 10) or TF-CBT treatment with and adjunct
of breathing biofeedback during exposure (N = 10) will be made. All patients (N
= 20) will receive all elements of TF-CBT treatment including the main element
of imaginary exposure. The PTSD patients in the TF-CBT + biofeedback condition
will receive one extra session for biofeedback training. In all subsequent
exposure sessions they will conduct breathing biofeedback as well as during
imaginal exposure in home work assignments.

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 treatment. During exposure
sessions, physiological parameters, immediate subjective distress levels and
PTSD symptom levels will be obtained in both conditions.

The burden and risks associated with participation in this study is reasonable.
Participants receive trauma focused behavioural therapy (TF-CBT), which is
considered to be the most effective treatment for PTSD and breathing
biofeedback is not an invasive procedure.