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

Emotional Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04273113
• Other study ID #: RG_17-105
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: March 28, 2020

Study information

• Verified date: September 2019
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: March 28, 2020
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Dysfunction

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficulties in Emotional Regulation (DERS)	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)
Primary	Five Facet Mindfulness Questionnaire (FFMQ)	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 a) 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)
Primary	Becks Depression Inventory (BDI-II)	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 a=.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)
Primary	Becks Anxiety Inventory (BAI)	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 a=.92) and test-retest reliability (r=.75).	15 minutes (pre, during and post biofeedback training)
Secondary	Heart Rate Variance (HRV) biofeedback	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