Emotional DysfunctionNCT04273113
Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?
A study testing Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety and HRV Biofeedback (Healing Rhythms) in people with Emotional Dysfunction, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Emotional Dysfunction
- What is being tested?
- Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety and HRV Biofeedback (Healing Rhythms)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2017to 28 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Emotional Dysfunction
- Being tested
- Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety, HRV Biofeedback (Healing Rhythms)
- Keywords
- Biofeedback training, Offenders, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks AnxietyOther
Patients asked to complete these 4 questionnaires pre, during and post biofeedback training
HRV Biofeedback (Healing Rhythms)Behavioural
Sensors placed on fingers to capture heart rate and skin temperature
| Study group | Role | What they receive |
|---|---|---|
| Heart Rate Variance (HRV) biofeedback training | Experimental | Patients to participate in 15 biofeedback sessions, 3 times a week (5 weeks in total). Receives: Other: Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety; Behavioral: HRV Biofeedback (Healing Rhythms) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 15 minutes (pre, during and post biofeedback training)
Secondary outcomes (1)
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.
Measured: 10 minutes per session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start11 Oct 2017
- Primary completion27 Apr 2018
- Study completion28 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgina V Atkinson, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273113
- Sponsor's protocol ID
- RG_17-105
- Status last verified
- Sep 2019
- First submitted
- 10 Jan 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?
- ClinicalTrials.gov ID
- NCT04273113
- Acronym / sponsor ID
- RG_17-105
- Conditions
- Emotional Dysfunction
- Keywords
- Biofeedback training, Offenders, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 28 Mar 2020 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Variance (HRV) biofeedback training | Experimental | Other: Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety, Behavioral: HRV Biofeedback (Healing Rhythms)Patients to participate in 15 biofeedback sessions, 3 times a week (5 weeks in total). |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks AnxietyPatients asked to complete these 4 questionnaires pre, during and post biofeedback training | Other | Heart Rate Variance (HRV) biofeedback training |
| HRV Biofeedback (Healing Rhythms)Sensors placed on fingers to capture heart rate and skin temperature | Behavioural | Heart Rate Variance (HRV) biofeedback training |
Primary outcome
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
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
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.
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).
1 secondary outcome
Heart Rate Variance (HRV) biofeedback
Time frame: 10 minutes per session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgina V Atkinson principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety and HRV Biofeedback (Healing Rhythms) in people with Emotional Dysfunction, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotional Regulation (DERS) (time frame: 30 minutes (pre, during and post biofeedback training)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.