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HRV Biofeedback for Brain Tumour Survivors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by British Columbia Cancer Agency
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01772498
First received: December 4, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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

Condition Intervention
Depression
Anxiety
Sleep Impairment
Pain Related Distress
Behavioral: heart rate variability biofeedback

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later) ] [ Designated as safety issue: No ]
    The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.

  • 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later) ] [ Designated as safety issue: No ]
    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 [ Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later) ] [ Designated as safety issue: No ]
    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 [ Time Frame: To be completed immediately post-intervention (8 weeks after the intiation of training) ] [ Designated as safety issue: No ]
    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) [ Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later) ] [ Designated as safety issue: No ]
    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) [ Time Frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later) ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index (Buysse et al., 1989)is a widely used self report measure of sleep quality.


Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772498

Contacts
Contact: Douglas P Ozier, PhD 604-877-6000 ext 672194 dozier@bccancer.bc.ca
Contact: Wolfgang Linden, PhD 604-822-4156 wlinden@psych.ubc.ca

Locations
Canada, British Columbia
BC Cancer Agency Not yet recruiting
Vancouver, British Columbia, Canada, V2L-5L6
Contact: Douglas P Ozier, PhD    604-877-6000 ext 672185    dozier@bccancer.bc.ca   
Contact: Gina MacKenzie, MSW    604-877-6000 ext 672802    gmacken@bccancer.bc.ca   
Sub-Investigator: Douglas P Ozier, PhD         
Sponsors and Collaborators
British Columbia Cancer Agency
University of British Columbia
Investigators
Principal Investigator: Wolfgang Linden, PhD UBC Department of Psychology
  More Information

Publications:
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01772498     History of Changes
Other Study ID Numbers: HRVB-123
Study First Received: December 4, 2012
Last Updated: January 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
depression
anxiety
sleep
pain
biofeedback
breathing
resonant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014