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

February 14, 2020 updated by: University of Birmingham
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 77 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Heart Rate Variance (HRV) biofeedback training
Patients to participate in 15 biofeedback sessions, 3 times a week (5 weeks in total).
Other: 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
Behavioral: HRV Biofeedback (Healing Rhythms)
Sensors placed on fingers to capture heart rate and skin temperature

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difficulties in Emotional Regulation (DERS)
Time Frame: 30 minutes (pre, during and post biofeedback training)
a 36 item self-report questionnaire developed to assess adult difficulties in emotional regulation. six specific dimensions which include; difficulties accepting emotional responses (acceptance), controlling impulse behaviours (impulse), emotional awareness (awareness), emotional clarity (clarity), assessing emotion regulation strategies (strategies) and engaging in goal oriented behaviour when emotionally aroused (goals). Internal consistency for Cronbach's alpha was .93 for the total scale and for DERS-A, .85, DERS-I, .89, DERS-A, .86, DERS-C, .80, DERS-S, .88, and DERS-G, .84
30 minutes (pre, during and post biofeedback training)
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: 30 minutes (pre, during and post biofeedback training)
Consists of 39 items assessing five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The FFMQ has been shown to have good internal consistency and significant relationships in the predicted directions with a variety of constructs related to mindfulness. The internal consistencies (Cronbach α) for these facets have been reported as 0.75 for FFMQ-NR, 0.83 for FFMQ-O, 0.87 for FFMQ-A, 0.91 for FFMQ-D, and 0.87 for FFMQ-NJ
30 minutes (pre, during and post biofeedback training)
Becks Depression Inventory (BDI-II)
Time Frame: 15 minutes (pre, during and post biofeedback training)
A 21-item self-report scale that surveys common symptoms of depression on a 4-point scale ranging from 0 to 3. Internal consistency of the BDI-II was demonstrated to be good (Cronbach's α=.91; Beck, Steer, Ball et al., 1996) and the 1-week test-retest reliability was shown to be high.
15 minutes (pre, during and post biofeedback training)
Becks Anxiety Inventory (BAI)
Time Frame: 15 minutes (pre, during and post biofeedback training)
Consists of 21 statements used to measure the severity of an individual's anxiety. When completing the BAI, individuals rate the severity of each symptom on a 4-point scale ranging from 0 (not at all) to 3 (severely-I could barely stand it). Good internal consistency (Cronbach's α=.92) and test-retest reliability (r=.75).
15 minutes (pre, during and post biofeedback training)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate Variance (HRV) biofeedback
Time Frame: 10 minutes per session
Heart rate coherence scores were assessed using the IoM butterfly Grapher. The coherence score is based upon a composite score of 0-100%; 0 being no coherence, 100% being perfect coherence.
10 minutes per session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Georgina V Atkinson, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG_17-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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