HRV Biofeedback for Brain Tumour Survivors

May 5, 2015 updated by: British Columbia Cancer Agency

Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors

This study is designed to take a first step toward testing the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner.

More specifically, this study has been designed to test several hypothesises. Each hypothesis is based on the prediction that, in a sample of psychologically distressed PBT survivors, a course of 8 HRVB sessions will demonstrate:

  • statistically significant reductions in levels of depression
  • statistically significant reductions in levels of anxiety
  • statistically significant increases in resting HRV
  • that reductions in anxiety and depression will be significantly, negatively correlated with increases in resting HRV
  • that the HRVB will be viewed as an acceptable intervention by the participants

In addition to the hypothesises stated above, the study will also investigate in a discovery oriented manner if the HRVB intervention will have positive impacts on the participants:

  • levels of sleep impairment
  • levels of pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose

This study will test the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner. HRVB has been shown to increase autonomic nervous system efficiency and also to decrease both anxiety and depression.

Background Rationale

Anxiety and depression are two of the strongest drivers of overall quality of life (Q of L) in survivors of primary, malignant brain tumour (PMBT). In a cohort of 73 PMBT survivors, "depression scores alone accounted for more than half of the all variance in Q of L scores" (Pelletier et al, 2003, p. 47). Anxiety symptoms were similarly negatively correlated with over-all Q of L(r = -..72) in brain tumour survivors (Janda et al., 2007). Evidence also suggests that, relative to the general population, brain tumour survivors exhibit much higher rates of both depression (Wellisch et al., 2002)and anxiety (Arnold et al., 2007).

Despite these striking findings around the prevalence and importance of anxiety and depression in the brain tumour population, not a single identified study has used a purely psychological intervention to ameliorate symptoms of depression and/or anxiety in this unique, understandably distressed population. Therefore, research of this kind is urgently needed.

Heart Rate variability Biofeedback

A course of HRVB, or some close variant of it, has shown statistically significant effects on depression and/or anxiety in numerous studies. HRVB has also recently been found to associated with improvements in pain and insomnia, two other common barriers to quality of life in PMBT survivors.

Design

Overview

As a very early stage study, a one group, open label design has been adopted.

Recruitment Process

Participants will be recruited by sending letters to potential participants identified through the BC Cancer Agency registry and by encouraging referrals from local oncologists.

Measures

The primary outcome measures will be resting HRV, the Beck Depression Inventory II, the Trait Anxiety Inventory. Secondary outcome will include the Short Form McGill Pain Questionnaire and the Pittsburgh Sleep Quality Index. Likert scale questionnaires will also be used after the intervention to assess the acceptability of the intervention.

HRVB Protocol

The protocol will involve 8 weekly sessions of up to 60 minutes each, following the general approach described by Lehrer, Vaschillo, & Vaschillo (2000). Participants will also practice breathing at their resonant frequency for 20 minutes each day at home.

Analysis

Three forms of analysis will be conducted. First, paired t-tests of residualized changes scores and effect sizes (Cohen's d) will be used to analyze pre-post changes on all of the psychometric measures and on the HRV data. Second, correlational analysis will also be used to see if there are expected associations between pre-post changes in emotion, pain and sleep measures relative to pre-post changes in resting HRV indices. Finally, means and standard deviations will be used to assess participants' likert ratings on the acceptability of the intervention.

Plans for Current Findings

Results will be developed for publication in relevant, peer reviewed scientific journals. Results will also be used to develop future research in this line, including studying the effciacy of HRVB with psychologically distressed caregivers of PMBT survivors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V2L-5L6
        • BC Cancer Agency

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • be a survivor of a primary, malignant brain tumour (WHO grades II-IV)
  • not have undergone any major treatment (chemotherapy, radiation, surgery) for previous three months
  • be psychologically distressed as indicated by a score of 11 or over on either the anxiety or depression subscale of the Psychosocial Screening Instrument for Cancer (PSSCAN)
  • be functionally capable of engaging in a time consuming study of this kind, (as indicated by a Karnofsky Scale score of 70/100)

Exclusion Criteria:

  • being incompetent to give consent independently
  • being actively suicidal (as per a score of 2 or above on the 1-5 point PSSCAN suicidality measure)
  • being actively delusional or psychotic
  • being judged, by the PI, to be too acutely distressed to benefit from and/or to successfully complete the intervention (e.g. scoring above 20 on either the depression or anxiety scale of the PSSCAN and/or , in the PI's clinical judgment, being without adequate supports or resources in place to adequately manage their current level of distress successfully enough to benefit from and/or to successfully complete the intervention)
  • being currently engaged in psychotherapy or another psychologically based treatment that is specifically designed to ameliorate psychological distress

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Heart rate variability biofeedback
Heart rate variability biofeedback training administered in eight, individual, weekly, one hour sessions. There will also be 20 minutes a day of resonant frequency breathing to be conducted at home. This intervention involves teaching subjects how to breath at their resonant frequency in a relaxed, diaphramatic manner.
Behavioral: heart rate variability biofeedback
Other Names:
  • resonant frequency biofeedback
  • RSA biofeedback

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in score on Beck Depression Inventory II at 8 weeks
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Widely used self report measure to assess for symptoms of depression.
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline in resting HRV High Frequency Power
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Baseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Resting Low Frequency HRV power (0.04-0.15 Hz)
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Baseline level of Low Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of Low Frequency HRV power (0.04-0.15 Hz)measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change in the standard deviation of all NN intervals from baseline in resting heart beat
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
This metric measures the standard deviation of normal beat-to-beat intervals (SDNN) that are present within the heart rythm. it is a time domain measure of HRV and it serves as a marker of overall adaptability of the nervous system.
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Subjective Acceptability ratings
Time Frame: To be completed immediately post-intervention (8 weeks after the intiation of training)
This will be a 5 point Likert scale asking how acceptable the participants found the experience of particiapting in the intervention to be , from "not at all acceptable" to "very acceptable".
To be completed immediately post-intervention (8 weeks after the intiation of training)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline score on the Short Form McGill Pain Questionnaire (SFMPQ)(Melzack, 1987)
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
The SFMPQ is a widely used measure of pain related experience.
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline in scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
The Pittsburgh Sleep Quality Index (Buysse et al., 1989)is a widely used self report measure of sleep quality.
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
British Columbia Cancer Agency

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolfgang Linden, PhD, UBC Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRVB-123

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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