Effects of Compassion Training to Patients Undergoing HSCT on Biological and Psychosocial Parameters
NCT ID: NCT03737084
Last Updated: 2020-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-04-03
2020-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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CBCT Intervention
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. The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.
CBCT Intervention
The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.
Control group
Control group participants will receive standard hospital care. Patients and caregivers of the control group will receive the same CBCT intervention at the end of the study.
No interventions assigned to this group
Interventions
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CBCT Intervention
The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
ALL
Yes
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Principal Investigators
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Elisa Kozasa, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Israelita de Ensino e Pesquisa Albert Einstein
Locations
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Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Countries
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References
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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.
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.
Other Identifiers
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CEP 2.373.269
Identifier Type: -
Identifier Source: org_study_id
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