Clinical trial NCT04273113: Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?
Official title: Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Dysfunction
Keywords: Biofeedback training, Offenders, Anxiety, Depression
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difficulties in Emotional Regulation (DERS)
timeFrame: 30 minutes (pre, during and post biofeedback training)
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 30 minutes (pre, during and post biofeedback training)
measure: Becks Depression Inventory (BDI-II)
timeFrame: 15 minutes (pre, during and post biofeedback training)
measure: Becks Anxiety Inventory (BAI)
timeFrame: 15 minutes (pre, during and post biofeedback training)
Secondary outcomes:
measure: Heart Rate Variance (HRV) biofeedback
timeFrame: 10 minutes per session
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
Study officials:
affiliation: University of Birmingham
name: Georgina V Atkinson
role: PRINCIPAL_INVESTIGATOR
References: