- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04273113
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
Unknown
Conditions
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
Interventional
Enrollment (Actual)
14
Phase
- 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
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Birmingham, United Kingdom
- University of Birmingham
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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
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 |
Intervention / Treatment |
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EXPERIMENTAL: Heart Rate Variance (HRV) biofeedback training
Patients to participate in 15 biofeedback sessions, 3 times a week (5 weeks in total).
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Patients asked to complete these 4 questionnaires pre, during and post biofeedback training
Sensors placed on fingers to capture heart rate and skin temperature
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties in Emotional Regulation (DERS)
Time Frame: 30 minutes (pre, during and post biofeedback training)
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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
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30 minutes (pre, during and post biofeedback training)
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Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: 30 minutes (pre, during and post biofeedback training)
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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
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30 minutes (pre, during and post biofeedback training)
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Becks Depression Inventory (BDI-II)
Time Frame: 15 minutes (pre, during and post biofeedback training)
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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.
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15 minutes (pre, during and post biofeedback training)
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Becks Anxiety Inventory (BAI)
Time Frame: 15 minutes (pre, during and post biofeedback training)
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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).
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15 minutes (pre, during and post biofeedback training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variance (HRV) biofeedback
Time Frame: 10 minutes per session
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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.
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10 minutes per session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
October 11, 2017
Primary Completion (ACTUAL)
April 27, 2018
Study Completion (ANTICIPATED)
March 28, 2020
Study Registration Dates
First Submitted
January 10, 2020
First Submitted That Met QC Criteria
February 14, 2020
First Posted (ACTUAL)
February 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 14, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID 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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