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

NCT04273113 | Unknown

• 1 other identifier: RG_17-105
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Dysfunction

Keywords

Biofeedback training, Offenders, Anxiety, Depression

Outcome Measures

Primary Outcomes (4)

• 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)

• 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 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)

  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)

  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 Outcomes (1)

• Heart Rate Variance (HRV) biofeedback

  10 minutes per session

Study Arms (1)

Heart Rate Variance (HRV) biofeedback training

EXPERIMENTAL

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; Behavioral: HRV Biofeedback (Healing Rhythms)

Interventions

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

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

Heart Rate Variance (HRV) biofeedback training

HRV Biofeedback (Healing Rhythms) BEHAVIORAL

Sensors placed on fingers to capture heart rate and skin temperature

Heart Rate Variance (HRV) biofeedback training

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Georgina V Atkinson

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: February 17, 2020
• Study Start: October 11, 2017
• Primary Completion: April 27, 2018
• Study Completion: March 28, 2020
• Last Updated: February 17, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)