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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]

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

Chronic pain

Emotion Dys-regulation

Condition category

Condition code

Mental Health

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]

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]

PTSD symptom severity: The PTSD Checklist for DSM-5 (PCL-5)

Timepoint [1]

Pre-intervention baseline to End of intervention and then 3-month follow-up.

Primary outcome [2]

Pain intensity and interference: the Brief Pain Inventory short form (BPI-sf)

Timepoint [2]

Pre-intervention baseline to End of intervention and then 3-month follow-up.

Primary outcome [3]

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]

Week 2 and 4 after starting treatment, to End of treatment

Secondary outcome [1]

Primary Outcome
Emotion Regulation measured by two questionnaires: Deficits in Emotion Regulation Scale (DERS)

Timepoint [1]

baseline, Week 2 and 4, to End of treatment and follow -up

Secondary outcome [2]

Depression measured by the Depression Anxiety Stress Scale (DASS-21)

Timepoint [2]

Baseline, end of treatment and 3-month follow-up

Secondary outcome [3]

Anxiety measured by the DASS-21

Timepoint [3]

Baseline, end of treatment and 3-month follow-up

Secondary outcome [4]

Stress measured by the DASS-21

Timepoint [4]

Baseline, end of treatment and 3-month follow-up

Secondary outcome [5]

Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire.

Timepoint [5]

baseline and end of treatment

Secondary outcome [6]

Participant expectation of treatment efficacy measured by the Credibility/Expectancy Questionnaire (CEQ)

Timepoint [6]

Baseline and end of treatment

Secondary outcome [7]

Primary Outcome: PTSD severity: Impact of Events Scale Revised (IES-R)

Timepoint [7]

Baseline to end of treatment and 3-month follow-up

Secondary outcome [8]

Primary Outcome: deficits in Emotion regulation:
Multidimensional Experiential Avoidance Questionnaire (MEAQ)

Timepoint [8]

Baseline to week 2, 4, end of treatment and follow up

Secondary outcome [9]

quality of time and disability: Pain Disability Index (PDI).

Timepoint [9]

Baseline, end of treatment and follow-up

Secondary outcome [10]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6151 - South Perth

Recruitment postcode(s) [2]

6000 - Perth

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch university

Address [1]

90 south street, Murdoch, Perth, WA 6150.

Country [1]

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]

Individual

Name [1]

Prof. Peter Drummond

Address [1]

Murdoch University
90 south street, Murdoch, Perth, WA 6150.

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Josef Martin Tatschl

Address [1]

University of Graz
Botanischer Garten der Uni Graz,
Schubertstr. 59, 8010 Graz

Country [1]

Austria

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Human Research Ethics Committee

Ethics committee address [1]

90 south street, Murdoch, Perth , WA 6150.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/01/2022

Approval date [1]

05/07/2022

Ethics approval number [1]

33650622x1

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Thea Chadwick

Address

Murdoch University
90 South street, Murdoch, Perth, WA 6150.

Country

Australia

Phone

+61424817734

Fax

thea.chadwick@murdoch.edu.au

Contact person for public queries

Name

Thea Chadwick

Address

Murdoch University
90 South street, Murdoch, Perth, WA 6150.

Country

Australia

Phone

+61424817734

Fax

thea.chadwick@murdoch.edu.au

Contact person for scientific queries

Name

Thea Chadwick

Address

Murdoch University
90 South street, Murdoch, Perth, WA 6150.

Country

Australia

Phone

+61424817734

Fax

thea.chadwick@murdoch.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17234	Informed consent form				Attached below	384689-(Uploaded-21-10-2022-13-49-48)-Study-related document.docx
17235	Ethical approval				Attached below	384689-(Uploaded-24-10-2022-12-49-02)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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