HRV Biofeedback for Brain Tumour Survivors - Full Text View

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:

MedlinePlus related topics: Anxiety Brain Cancer Cancer Depression

U.S. FDA Resources

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

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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

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:

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.

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.

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.

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.

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:

Anxiety Disorders
Brain Neoplasms
Depression
Depressive Disorder
Mental Disorders
Central Nervous System Neoplasms
Nervous System Neoplasms

Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 16, 2013