HRV Biofeedback for Brain Tumour Survivors
Primary Purpose
Depression, Anxiety, Sleep Impairment
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
heart rate variability biofeedback
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring depression, anxiety, sleep, pain, biofeedback, breathing, resonant
Eligibility Criteria
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
Sites / Locations
- BC Cancer Agency
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heart rate variability biofeedback
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline in score on Beck Depression Inventory II at 8 weeks
Widely used self report measure to assess for symptoms of depression.
Change from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.
Change from baseline in resting HRV High Frequency Power
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
Resting Low Frequency HRV power (0.04-0.15 Hz)
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
Change in the standard deviation of all NN intervals from baseline in resting heart beat
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.
Subjective Acceptability ratings
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".
Secondary Outcome Measures
Change from baseline score on the Short Form McGill Pain Questionnaire (SFMPQ)(Melzack, 1987)
The SFMPQ is a widely used measure of pain related experience.
Change from baseline in scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1989)
The Pittsburgh Sleep Quality Index (Buysse et al., 1989)is a widely used self report measure of sleep quality.
Full Information
NCT ID
NCT01772498
First Posted
December 4, 2012
Last Updated
May 5, 2015
Sponsor
British Columbia Cancer Agency
Collaborators
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01772498
Brief Title
HRV Biofeedback for Brain Tumour Survivors
Official Title
Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Suspended
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Sleep Impairment
Keywords
depression, anxiety, sleep, pain, biofeedback, breathing, resonant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heart rate variability biofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
heart rate variability biofeedback
Other Intervention Name(s)
resonant frequency biofeedback, RSA biofeedback
Primary Outcome Measure Information:
Title
Change from baseline in score on Beck Depression Inventory II at 8 weeks
Description
Widely used self report measure to assess for symptoms of depression.
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Title
Change from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
Description
The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Title
Change from baseline in resting HRV High Frequency Power
Description
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
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Title
Resting Low Frequency HRV power (0.04-0.15 Hz)
Description
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
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Title
Change in the standard deviation of all NN intervals from baseline in resting heart beat
Description
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.
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Title
Subjective Acceptability ratings
Description
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".
Time Frame
To be completed immediately post-intervention (8 weeks after the intiation of training)
Secondary Outcome Measure Information:
Title
Change from baseline score on the Short Form McGill Pain Questionnaire (SFMPQ)(Melzack, 1987)
Description
The SFMPQ is a widely used measure of pain related experience.
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Title
Change from baseline in scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Description
The Pittsburgh Sleep Quality Index (Buysse et al., 1989)is a widely used self report measure of sleep quality.
Time Frame
comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Linden, PhD
Organizational Affiliation
UBC Department of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V2L-5L6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12125966
Citation
Pelletier G, Verhoef MJ, Khatri N, Hagen N. Quality of life in brain tumor patients: the relative contributions of depression, fatigue, emotional distress, and existential issues. J Neurooncol. 2002 Mar;57(1):41-9. doi: 10.1023/a:1015728825642.
Results Reference
background
PubMed Identifier
18061752
Citation
Janda M, Steginga S, Langbecker D, Dunn J, Walker D, Eakin E. Quality of life among patients with a brain tumor and their carers. J Psychosom Res. 2007 Dec;63(6):617-23. doi: 10.1016/j.jpsychores.2007.06.018.
Results Reference
background
PubMed Identifier
12112483
Citation
Wellisch DK, Kaleita TA, Freeman D, Cloughesy T, Goldman J. Predicting major depression in brain tumor patients. Psychooncology. 2002 May-Jun;11(3):230-8. doi: 10.1002/pon.562.
Results Reference
background
PubMed Identifier
18314416
Citation
Arnold SD, Forman LM, Brigidi BD, Carter KE, Schweitzer HA, Quinn HE, Guill AB, Herndon JE 2nd, Raynor RH. Evaluation and characterization of generalized anxiety and depression in patients with primary brain tumors. Neuro Oncol. 2008 Apr;10(2):171-81. doi: 10.1215/15228517-2007-057. Epub 2008 Feb 26.
Results Reference
background
PubMed Identifier
10999236
Citation
Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.
Results Reference
background
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HRV Biofeedback for Brain Tumour Survivors
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