Clinical trial NCT03737084: Effects of Compassion Training to Patients Undergoing HSCT on Biological and Psychosocial Parameters
Official title: Effects of the Cognitively-Based Compassion Training (CBCT) Adapted to Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) and Their Caregivers on Biological and Psychosocial Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: hematopoietic stem cell transplant
cancer
compassion
meditation
depression
anxiety
heart rate variability
resilience
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: The compassion intervention (CBCT) will be performed during the period of hospitalization, in the hospital room, and will be applied simultaneously to the patient his caregiver.

Control Group: Patients and caregivers in the control group will receive standard hospital care. Patients and caregivers of the control group will receive the same compassion intervention at the end of the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hematopoietic stem cell transplant (HSCT) experience is emotionally and physically stressful for cancer patients who undergo this procedure. This study aims to evaluate the effects of Cognitively-Based Compassion Training (CBCT) on depression and anxiety symptoms, levels of resilience, hope and self-compassion in patients undergoing HSCT and their caregivers. As well as assessing the effects of CBCT on clinical conditions in patients and cortical activity and heart rate variability in caregivers.

Detailed description: The study hopes to show the positive effects of compassion training in patients and their caregivers.

Overall aim:

This study aims to evaluate the effects of Cognitively-Based Compassion Training (CBCT) on: depression and anxiety symptoms; levels of hope; resilience; mindfulness; self-compassion and quality of life. The study also aims to demonstrate whether CBCT training has any effect on clinical parameters of transplanted patients, as well as whether it has an effect on cortical activity and heart rate variability inpatients and caregivers.

Specific objectives:

1. Develop an adaptation of the CBCT protocol for hospitalized patients;
2. To evaluate the effect of CBCT on depressive and anxious symptoms in patients and their caregivers;
3. To evaluate the effect of CBCT on resilience, quality of life and self-compassion in patients and their caregivers;
4. Investigating the CBCT training results in altering the cortical activity of patients and caregivers while performing a recall task of recent autobiographical experiences;
5. Investigate whether CBCT training results in changes in heart rate variability in patients and caregivers;
6. To investigate whether CBCT training has any effect on patient's levels of symptoms, such as: pain, nausea, insomnia, among others;
7. To evaluate how correlations between psychosocial factors and biological markers: cortical activity and heart rate variability;
8. Evaluate perceptions and impressions of patients and caregivers on the protocol.

Eligibility criteria: Inclusion Criteria:

* patients referred for HSCT attended at Albert Einstein Hospital, as well as their respective caregivers.

Exclusion Criteria:

* history of severe psychiatric disorders and neurological diseases.

Primary outcomes:
measure: Change from Baseline Anxiety and Depression symptoms at 1 week after intervention
timeFrame: baseline,1 week after intervention
measure: Change from Baseline Resilience level at 1 week after intervention
timeFrame: baseline; 1 week after intervention.
measure: Change from Baseline Self-Compassion level at 1 week after intervention
timeFrame: baseline; 1 week after intervention.
measure: Change from Baseline Perceived Stress level at 1 week after intervention
timeFrame: baseline; 1 week after intervention.
Secondary outcomes:
Other outcomes:
measure: Cortical activity
timeFrame: baseline, 1 week after intervention
measure: Heart rate variability (HRV)
timeFrame: baseline, 1 week after intervention
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Instituto Israelita de Ensino e Pesquisa Albert Einstein
name: Elisa Kozasa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.
citation: Dodds SE, Pace TW, Bell ML, Fiero M, Negi LT, Raison CL, Weihs KL. Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study. Support Care Cancer. 2015 Dec;23(12):3599-608. doi: 10.1007/s00520-015-2888-1. Epub 2015 Aug 16.