Targeting Autonomic Flexibility Through Heart Rate Variability Biofeedback to Improve PTSD and Chronic Pain

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: 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 CONDITION: Mental Health ‐ Other mental health disorders Posttraumatic stress disorder ;Chronic pain;Emotion Dys‐regulation ; ; Posttraumatic stress disorder ; Chronic pain ; Emotion Dys‐regulation PRIMARY OUTCOME: Heart Rate Variability (HRV) measured by two, five minute seated electrocardiogram (ECG) recordings (one while recalling neutral memories and one while recalling distressing memories). [Week 2 and 4 after starting treatment, to End of treatment; ; ] Pain intensity and interference: the Brief Pain Inventory short form (BPI‐sf) [Pre‐intervention baseline to End of intervention and then 3‐month follow‐up. ] PTSD symptom severity: The PTSD Checklist for DSM‐5 (PCL‐5) [Pre‐intervention baseline to End of intervention and then 3‐month follow‐up. ] 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. SECONDARY OUTCOME: Anxiety measured by the DASS‐21[Baseline, end of treatment and 3‐month follow‐up] Depression measured by the Depression Anxiety Stress Scale (DASS‐21)[Baseline, end of treatment and 3‐month follow‐up] Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA‐2) questionnaire.[baseline and end of treatment ] Participant expectation of treatment efficacy measured by the Credibility/Expectancy Questionnaire (CEQ)[Baseline and end of treatment ] Primary Outcome ; Emotion Regulation measured by two questionnaires: Deficits in Emotion Regulation Scale (DERS) [baseline, Week 2 and 4, to End of treatment and follow ‐up] Primary Outcome: deficits in Emotion regulation: ; Multidimensional Experiential Avoidance Questionnaire (MEAQ) [Baseline to week 2, 4, end of treatment and follow up] Primary Outcome: PTSD severity: Impact of Events Scale Revised (IES‐R)[Baseline to end of treatment and 3‐month follow‐up] quality of time and disability: Pain Disability Inde X(PDI). [Baseline, end of treatment and follow‐up] Stress measured by the DASS‐21[Baseline, end of treatment and 3‐month follow‐up] Volume of biofeedback practice (i.e. amount of training completed at home) ‐ this is recorded on the biofeedback software (EliteHRV) and automatically sent to the researcher dashboard.[daily through the intervention ]
Epistemonikos ID: 2a43af43e705c8804efca35bbc502fb92cbad30b
First added on: Feb 20, 2024