Heart Rate Variability Biofeedback in Young People With Autism

An Investigation Into the Use of Heart Rate Variability Biofeedback in People With Autistic Spectrum Disorder

Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them.

Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Controlling heart rate using biofeedback has been shown in some studies to help people manage symptoms of stress such as anxiety and depression.

This research will explore whether biofeedback can help people with autism or Asperger syndrome reduce reported symptoms of stress.

Participants with a diagnosis of high functioning autism will be invited to use a biofeedback device that helps them to regulate their heart rate. People who enrol for the study will be randomly assigned different biofeedback devices. Training and support in the use of the device will be provided to participants.

Assessment will involve obtaining questionnaire reports from participants and their carers about participant levels of anxiety, depression and sensory symptoms, demographics and lifestyle. These assessments will be carried out at the beginning, in the middle and at the end of the study to see if there are any differences in how each participant's heart rate changes, whether there are any changes in participant's reported symptoms. Participants will be asked to give daily reports on their progress to monitor stress levels, usability of device and dropout rates. The overall aim is to determine whether biofeedback is a way of helping people with autism to reduce symptoms of stress.

Study Overview

• Status: Completed
• Conditions: Autistic Disorders Spectrum
• Intervention / Treatment: Device: Biofeedback

Detailed Description

Based on a review of the literature, it is hypothesised that HRV biofeedback could offer a means to help regulate ANS dysfunction and symptoms such as anxiety & depression in people with autistic spectrum disorder. To date, no studies have been identified which report on the pre post measurement of HRV in autism using a longitudinal design. Furthermore, to date, no published studies have reported on the use of portable HRV biofeedback devices as a potential intervention for individuals with autism to help manage symptoms such as anxiety & depression.

An initial usability evaluation has been carried out and approved by Ulster University faculty of Life & Health sciences in 2014 to determine the timings required to undertake the assessment and assess usability of equipment, measures, physiological assessment sensors and recording of data (see appendix I for a summary). The current study aims to assess the feasibility of employing a technology intervention for people with autism using small portable HRV biofeedback devices to help manage symptoms such as anxiety. Because of the differences in physiology seen in many people with autism, any study aiming to understand a potential new intervention for this population should include pre and post intervention assessments of they react physiologically and respond to information. This study will therefore use pre and post questionnaire assessment from participants and their carers, but will also record participant's heart rate variability pre and post intervention to assess any changes in participants underlying physiology.

Aim To understand the use of heart rate variability biofeedback in people with autistic spectrum disorder.

Objectives

1. To provide a home based HRV biofeedback intervention to people with autistic spectrum disorder.
2. To collect data from participants and their carers on participant anxiety, depression and physiological arousal before and after using a biofeedback device.
3. To assess the adoption of HRV biofeedback technology in terms of user acceptance and levels of dropout.
4. To evaluate the risks and benefits of this technology in terms of stress management.
5. To develop recommendations on the use of HRV biofeedback for people with autistic spectrum disorder.

Methodology The study will follow the revised MRC guidelines for the development and evaluation of complex interventions, namely a feasibility and piloting study which will look at dropout rates, test methodology and procedure, and determine the size of sample that would eventually be needed to obtain estimates of effect size in a full scale randomised trial.

Design The study is essentially a clinical trial that involves a detailed follow up of a sample of people with autistic spectrum disorder (n=39, IQ>70) using repeated measures in a randomised control experimental design.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT37 0QB
      • South Eastern Health Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Confirmed diagnosis of High functioning autism / Asperger's syndrome using standardized tests (ADOS / ADI / DISCO), IQ over 70, English speaker Existing or previous client resident within South Eastern Health & Social Care Trust catchment area.

Exclusion Criteria:

Learning disability (IQ<70). Cardiac condition / pacemaker. Drug /alcohol addiction Current psychosis Current suicidal ideation. Eczema / psoriasis Immunosuppressing condition MRSA / C Difficile

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: Biofeedback; Technology to provide Heart Rate Variability Biofeedback
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Anxiety Scale using Beck Youth Inventory	10-15 minute Questionnaire	At baseline, after six weeks and at end-point at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any change in Heart rate variability (ideally key metrics increased)	Physiological recording of heart rate variability using single lead ECG	At baseline, after six weeks and at end-point at 12 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: South Eastern Health and Social Care Trust

Publications and helpful links

General Publications

• Coulter H, Donnelly M, Mallett J, Kernohan WG. Heart Rate Variability Biofeedback to Treat Anxiety in Young People With Autism Spectrum Disorder: Findings From a Home-Based Pilot Study. JMIR Form Res. 2022 Aug 26;6(8):e37994. doi: 10.2196/37994.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2016
• Primary Completion (Actual): August 9, 2017
• Study Completion (Actual): August 9, 2017

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRAS139122; 15/NI/0255 (Other Identifier: UK-HRA-REC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No