Trial Information

Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors

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.