HRV Biofeedback for Brain Tumour Survivors

NCT01772498 | Suspended

• 1 other identifier: HRVB-123
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Depression; Anxiety; Sleep Impairment

Keywords

depression; anxiety; sleep; pain; biofeedback; breathing; resonant

Outcome Measures

Primary Outcomes (6)

• Change from baseline in score on Beck Depression Inventory II at 8 weeks

  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

  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

  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)

  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

  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

  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 Outcomes (2)

• Change from baseline score on the Short Form McGill Pain Questionnaire (SFMPQ)(Melzack, 1987)

  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)

  comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)

Study Arms (1)

Heart rate variability biofeedback

EXPERIMENTAL

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

Interventions

heart rate variability biofeedback BEHAVIORAL

Also known as: resonant frequency biofeedback, RSA biofeedback

Heart rate variability biofeedback

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• University of British Columbia: collaborator

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V2L-5L6, Canada

Location

Related Publications (5)

• 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.

  PMID: 12125966 BACKGROUND

• 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.

  PMID: 18061752 BACKGROUND

• 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.

  PMID: 12112483 BACKGROUND

• 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.

  PMID: 18314416 BACKGROUND

• 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.

  PMID: 10999236 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Pain; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Wolfgang Linden, PhD

  UBC Department of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: January 21, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

CA (1)