Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Resting Low Frequency HRV power (0.04-0.15 Hz)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Resting Low Frequency HRV power (0.04-0.15 Hz)
时间窗: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
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 from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
时间窗: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.
Change from baseline in resting HRV High Frequency Power
时间窗: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
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
Change in the standard deviation of all NN intervals from baseline in resting heart beat
时间窗: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
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.
Change from baseline in score on Beck Depression Inventory II at 8 weeks
时间窗: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Widely used self report measure to assess for symptoms of depression.
Subjective Acceptability ratings
时间窗: To be completed immediately post-intervention (8 weeks after the intiation of training)
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".
次要结局
- 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))