Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?

NCT ID: NCT04273113

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2020-03-28

Brief Summary

14 participants residing in a forensic psychiatric hospital completed 15 Heart Rate Variance (HRV) biofeedback sessions. They completed 4 psychometric questionnaires, pre, during and post biofeedback training.

Detailed Description

This study aimed to establish whether Heart Rate Variance (HRV) biofeedback improved HRV coherence as well as psychological well-being (depression, anxiety, emotion regulation, and mindfulness) over the course of 15 biofeedback sessions in a sample of 14 patients with varying diagnoses; Paranoid Schizophrenia, Schizoaffective Disorder, Personality Disorder or Mixed Diagnosis. All 14 participants (n=10 male, n=4 female) participated in 15 biofeedback sessions. The study was researched and treatment was facilitated by a trainee forensic psychologist working with both male and female offenders residing within a Forensic Psychiatric Hospital, on both low and medium secure wards. An average coherence percentage was captured using the Wild Devine Programme® Relaxing Rhythms software for each session. Quantitative data were collected and analysed before, during and after biofeedback treatment to assess whether there was improvement in psychometric measures of depression, anxiety, emotion regulation and facets of mindfulness. A quasi experimental 'A-B-A design' was employed to assess the research questions.

Conditions

Emotional Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heart Rate Variance (HRV) biofeedback training

Patients to participate in 15 biofeedback sessions, 3 times a week (5 weeks in total).

Group Type: EXPERIMENTAL

Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety

Intervention Type: OTHER

Patients asked to complete these 4 questionnaires pre, during and post biofeedback training

HRV Biofeedback (Healing Rhythms)

Intervention Type: BEHAVIORAL

Sensors placed on fingers to capture heart rate and skin temperature

Interventions

Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety

Patients asked to complete these 4 questionnaires pre, during and post biofeedback training

Intervention Type: OTHER

HRV Biofeedback (Healing Rhythms)

Sensors placed on fingers to capture heart rate and skin temperature

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male and female offenders aged 18 and above.
• Male and female offenders who reside in a medium and low Forensic Psychiatric Hospital.
• Individuals who have the capacity to consent to take part in the research
• Individuals deemed mentally stable and were found to have capacity to consent by their Multi-Disciplinary Team (MDT).

Exclusion Criteria

• Individuals under the age of 18.
• Individuals who are not detained in a Forensic Psychiatric Hospital.
• Individuals deemed not well enough to consent by their Multi-Disciplinary Team (MDT).
• A level of cognitive impairment determined by diagnosis that would prevent individuals from understanding the feedback obtained. via pictorial or verbal prompts
• Individuals with specific breathing difficulties (e.g., chronic obstructive pulmonary disease) that would restrict them from being able to practice the breathing techniques.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georgina V Atkinson

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

University of Birmingham

Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

RG_17-105

Identifier Type: -

Identifier Source: org_study_id