Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000119695
Ethics application status
Approved
Date submitted
10/10/2022
Date registered
3/02/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
3/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting Autonomic Flexibility Through Heart Rate Variability Biofeedback to Improve PTSD and Chronic Pain
Scientific title
Common Factors in Chronic Pain and Posttraumatic Stress Disorder (PTSD): Targeting Autonomic Flexibility as an Index of Capacity for Regulated Emotional Responding Through Heart Rate Variability Biofeedback
Secondary ID [1] 308014 0
None
Universal Trial Number (UTN)
U1111-1283-3250
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 327688 0
Chronic pain 327689 0
Emotion Dys-regulation 328908 0
Condition category
Condition code
Mental Health 324771 324771 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324465 0
Behaviour
Comparator / control treatment
Following baseline measures being collected, participants will be randomly allocated to begin treatment immediately or to the wait-list control condition. Random allocation will be computer generated. Those assigned to the wait-list condition will wait 6 weeks and then repeat all measures (baseline), before commencing the intervention.
Control group
Active

Outcomes
Primary outcome [1] 332595 0
PTSD symptom severity: The PTSD Checklist for DSM-5 (PCL-5)
Timepoint [1] 332595 0
Pre-intervention baseline to End of intervention and then 3-month follow-up.
Primary outcome [2] 332604 0
Pain intensity and interference: the Brief Pain Inventory short form (BPI-sf)
Timepoint [2] 332604 0
Pre-intervention baseline to End of intervention and then 3-month follow-up.
Primary outcome [3] 332888 0
Heart Rate Variability (HRV) measured by two, five minute seated electrocardiogram (ECG) recordings (one while recalling neutral memories and one while recalling distressing memories).
Timepoint [3] 332888 0
Week 2 and 4 after starting treatment, to End of treatment
Secondary outcome [1] 414005 0
Primary Outcome
Emotion Regulation measured by two questionnaires: Deficits in Emotion Regulation Scale (DERS)
Timepoint [1] 414005 0
baseline, Week 2 and 4, to End of treatment and follow -up
Secondary outcome [2] 415599 0
Depression measured by the Depression Anxiety Stress Scale (DASS-21)
Timepoint [2] 415599 0
Baseline, end of treatment and 3-month follow-up
Secondary outcome [3] 415600 0
Anxiety measured by the DASS-21
Timepoint [3] 415600 0
Baseline, end of treatment and 3-month follow-up
Secondary outcome [4] 415601 0
Stress measured by the DASS-21
Timepoint [4] 415601 0
Baseline, end of treatment and 3-month follow-up
Secondary outcome [5] 415602 0
Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire.
Timepoint [5] 415602 0
baseline and end of treatment
Secondary outcome [6] 415603 0
Participant expectation of treatment efficacy measured by the Credibility/Expectancy Questionnaire (CEQ)
Timepoint [6] 415603 0
Baseline and end of treatment
Secondary outcome [7] 418077 0
Primary Outcome: PTSD severity: Impact of Events Scale Revised (IES-R)
Timepoint [7] 418077 0
Baseline to end of treatment and 3-month follow-up
Secondary outcome [8] 418078 0
Primary Outcome: deficits in Emotion regulation:
Multidimensional Experiential Avoidance Questionnaire (MEAQ)
Timepoint [8] 418078 0
Baseline to week 2, 4, end of treatment and follow up
Secondary outcome [9] 418079 0
quality of time and disability: Pain Disability Index (PDI).
Timepoint [9] 418079 0
Baseline, end of treatment and follow-up
Secondary outcome [10] 418080 0
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.
Timepoint [10] 418080 0
daily through the intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed heart condition which causes heart arrhythmias.
Current diagnosis of cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We previously based our power calculation off achieving 80% power for a longitudinal multilevel mediation model, utilising the bootstrap method, a sample size of 44 is required (Pan, Liu, Miao & Yuan, 2018).
In addition - After some additional consultation, for the efficacy of the intervention (which requires linear mixed modelling power calculations), a total sample of 70 is required. Based on similar biofeedback intervention studies, which report a retention rate between 94% (Minen et al., 2021) and 82% (Reyes, 2014), it is anticipated that 80 participants will recruited to engage in the intervention, with a retention rate of 88%.




Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
1/03/2023
Date of last participant enrolment
Anticipated
30/07/2024
Actual
Date of last data collection
Anticipated
29/10/2024
Actual
Sample size
Target
70
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 38547 0
6151 - South Perth
Recruitment postcode(s) [2] 38734 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 312266 0
University
Name [1] 312266 0
Murdoch university
Country [1] 312266 0
Australia
Primary sponsor type
Individual
Name
Dr. Danielle Mathersul
Address
Murdoch University
90 south street, Murdoch, Perth, WA 6150.
Country
Australia
Secondary sponsor category [1] 313807 0
Individual
Name [1] 313807 0
Prof. Peter Drummond
Address [1] 313807 0
Murdoch University
90 south street, Murdoch, Perth, WA 6150.
Country [1] 313807 0
Australia
Other collaborator category [1] 282553 0
Individual
Name [1] 282553 0
Josef Martin Tatschl
Address [1] 282553 0
University of Graz
Botanischer Garten der Uni Graz,
Schubertstr. 59, 8010 Graz
Country [1] 282553 0
Austria

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311640 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 311640 0
Ethics committee country [1] 311640 0
Australia
Date submitted for ethics approval [1] 311640 0
01/01/2022
Approval date [1] 311640 0
05/07/2022
Ethics approval number [1] 311640 0
33650622x1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121814 0
Ms Thea Chadwick
Address 121814 0
Murdoch University
90 South street, Murdoch, Perth, WA 6150.
Country 121814 0
Australia
Phone 121814 0
+61424817734
Fax 121814 0
Email 121814 0
[email protected]
Contact person for public queries
Name 121815 0
Thea Chadwick
Address 121815 0
Murdoch University
90 South street, Murdoch, Perth, WA 6150.
Country 121815 0
Australia
Phone 121815 0
+61424817734
Fax 121815 0
Email 121815 0
[email protected]
Contact person for scientific queries
Name 121816 0
Thea Chadwick
Address 121816 0
Murdoch University
90 South street, Murdoch, Perth, WA 6150.
Country 121816 0
Australia
Phone 121816 0
+61424817734
Fax 121816 0
Email 121816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17234Informed consent form    Attached below 384689-(Uploaded-21-10-2022-13-49-48)-Study-related document.docx
17235Ethical approval    Attached below 384689-(Uploaded-24-10-2022-12-49-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.