Clinical trial · Interventional
HRV Biofeedback for Brain Tumour Survivors
Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Sleep Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| heart rate variability biofeedback | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Heart rate variability biofeedback
- description
- 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.
- interventionNames
- Behavioral: heart rate variability biofeedback
Primary outcomes (6)
- measure
- Change from baseline in score on Beck Depression Inventory II at 8 weeks
- timeFrame
- comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
- description
- Widely used self report measure to assess for symptoms of depression.
- measure
- Change from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDPelletier 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
- BACKGROUNDJanda 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
- BACKGROUNDWellisch 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
- BACKGROUNDArnold 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
- BACKGROUNDLehrer 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