None listed
Conditions
Brief summary
Introduction Individuals with co-morbid chronic pain (CP) and PTSD report greater symptom severity, anxiety, depression, disability, and opioid use than those with only one of these conditions. Deficits in emotion regulation (ER) and autonomic disturbance, represented through Heart Rate Variability (HRV), are both evidenced to interact with and perpetuate the symptoms of CP and PTSD. Furthermore, theoretic models suggest that autonomic dysfunction leads to psychophysiological inflexibility, reducing capacity for regulated emotional responding. This predisposes an individual to respond to potential threat with anxiety. Focusing on these trans-diagnostic factors, which may account for aspects of the comorbidity of symptoms between CP and PTSD, presents valuable treatment targets to interrupt the perpetuating cycle of both. While HRV biofeedback has been reported to improve autonomic flexibility and the symptoms of CP and PTSD separately, it is unclear whether these positive results would be replicated in people with both conditions. Furthermore, while the association with HRV and ER is well documented, it remains unclear whether change in self-reported ER mediates improvement in CP and PTSD symptoms through HRV biofeedback. Consequently, the study aims to answer the following research questions: a) does modifying HRV through biofeedback change symptoms of co-occurring CP and PTSD, b) do changes in ER mediate change in symptoms of CP and PTSD, and c) does change in HRV precede change in ER. Methods A six-week randomised wait-list control HRV biofeedback intervention will be conducted with 50 participants who have both a chronic pain diagnosis and PTSD symptoms. Participants will be instructed to practice at home daily for 40-minutes, as well as attending three, fortnightly training sessions. ECG and psychometric data will be collected at baseline, two mid-points during the intervention (week 2 and 4), as well as end of intervention and three month follow-up. Short daily portable ECG recordings and adherence to biofeedback training will also be collected.
Interventions
The 6- week biofeedback intervention will consist of:
Baseline intake and evaluation session (approximately 50 minutes): Following completion of self-report measures via Qualtrics, the participants ECG data being recorded in 2 5-minute samples while the participants sit and watch a neutral video and then recall distress memories, respectively. Participants will also complete a suite of psychometric measures.
Whilst still connected to the ECG monitor, the participant will then undertake a resona
The 6- week biofeedback intervention will consist of: Baseline intake and evaluation session (approximately 50 minutes): Following completion of self-report measures via Qualtrics, the participants ECG data being recorded in 2 5-minute samples while the participants sit and watch a neutral video and then recall distress memories, respectively. Participants will also complete a suite of psychometric measures. Whilst still connected to the ECG monitor, the participant will then undertake a resonance frequency assessment, breathing at 4.5, 5, 5.5, 6, 6.5 and 7 breaths per minute for 3 minutes at each frequency. The resonance frequency will be determined and the participant will be instructed and guided to breathe at this pace following the pacer on their biofeedback smartphone interface. Participant is instructed on how to circular breathe slowly without hyperventilating. The participant is instructed to practice at home with their biofeedback device (Polar H10) and interface (EliteHRV) at their resonant frequency 20-minutes twice daily. They will also be instructed to perform a 2-minute daily HRV recording using the same equipment first thing in the morning in a seated position (prior to caffeine or food intake), as well as complete an ambulatory psychometric measure of their current self-reported emotion regulation capacity (modified ERQ) via the SEMA app. Mid-treatment sessions (same time of day as baseline session) The participants will attend the clinic with the researcher at week two and four of the intervention. Week 2: baseline neutral and distressing ECG recordings are repeated as well as psychometric measures. Difficulties in doing the training are discussed and support is provided to ensure participant is breathing correctly and not hyperventilating. If the participant had mastered this, they are instructed to breathe in phase with heart rate changes on the Elite HRV interface – i.e. when their HR increases they inhale and when their HR decreases they exhale (as shown on the biofeedback device display). The goal of this is to create the greatest amplitude heart rate changes. If the participant loses their sync with this or finds it difficult they can return to following the pacer. Week 4: Baseline measures repeated (psychometrics and ECG recording). Participant practices using device with support from researcher and researcher provides additional feedback regarding participants breathing and accuracy of achieving nervous system balance. Address any challenges with home practice. (45 mins) End Treatment: Following review of training, HRV is assessed (2, 5 min ECG recording). Participants also complete all other baseline measures: PTSD symptoms, pain measures, disability, self-reported ER.
Sponsors
Dr. Danielle Mathersul
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 65 Years
Healthy volunteers
No
Inclusion criteria
Have a current diagnosis of chronic pain by a medical practitioner. Current posttraumatic stress symptoms at a clinical level of significance, as determined by a score of 31 or higher on the PTSD Check List (PCL-5). Be able to attend all treatment sessions and assessments.
Exclusion criteria
Diagnosed heart condition which causes heart arrhythmias. Current diagnosis of cancer.
Outcome results
None listed