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Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors

19 Years
Not Enrolling
Depression, Anxiety, Sleep Impairment, Pain Related Distress

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Trial Information

Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors


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

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.



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.


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.


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Widely used self report measure to assess for symptoms of depression.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Wolfgang Linden, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UBC Department of Psychology


Canada: Health Canada

Study ID:




Start Date:

January 2013

Completion Date:

June 2014

Related Keywords:

  • Depression
  • Anxiety
  • Sleep Impairment
  • Pain Related Distress
  • depression
  • anxiety
  • sleep
  • pain
  • biofeedback
  • breathing
  • resonant
  • Anxiety Disorders
  • Brain Neoplasms
  • Depression
  • Depressive Disorder