Effects of Compassion Training to Patients Undergoing HSCT on Biological and Psychosocial Parameters

Hematopoietic Stem Cell Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737084
• Other study ID #: CEP 2.373.269
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: May 2019
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo
Brazil	Instituto Israelita de Ensino e Pesquisa Albert Einstein	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Erratum in: Support Care Cancer. 2015 Dec;23(12):3609-11. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortical activity	Measured by Near-Infrared Spectroscopy (NIRS), in an experiment using a paradigm of autobiographical events, remembering stressful and positive memories.	baseline, 1 week after intervention
Other	Heart rate variability (HRV)	Measured from the cardiac activity record through a Polar® V800 heart monitor.	baseline, 1 week after intervention
Primary	Change from Baseline Anxiety and Depression symptoms at 1 week after intervention	Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items, 7 for anxiety (HADS-A) and 7 items for depression (HADS-D). The final score ranges from 0 to 21 points in each subscale, the higher the score, the greater the symptoms of anxiety or depression (Zigmond and Snaith, 1983).	baseline,1 week after intervention
Primary	Change from Baseline Resilience level at 1 week after intervention	Resilience Scale (RS). Developed by Wagnild and Young (Wagnild and Young, 1993). Composed of 25 items. The Resilience Scale was applied to measure the degree of resilience. It measures two main factors: 'personal competence' (17 items) and 'acceptance of self and life' (8 items). The response scale ranges from 1 ('totally disagree') to 7 ('totally agree'). The total score ranges from 26 to 175 points. The higher the score the higher the level of resilience.	baseline; 1 week after intervention.
Primary	Change from Baseline Self-Compassion level at 1 week after intervention	Self-Compassion Scale. This is a 26-item scale that measures how one typically acts toward oneself in difficult times. These items were designed to assess how respondents perceive their actions toward themselves in difficult times and are rated using a Likert-type scale anchored from 1 (almost never) to 5 (almost always). The scale ranges from 26 to 130 points. The higher the score the higher the level of Self-Compassion. Developed by Kristin Neff.	baseline; 1 week after intervention.
Primary	Change from Baseline Perceived Stress level at 1 week after intervention	Perceived Stress Scale (PSS). This scale measures the degree to which individuals perceive situations as stressful. Composed of 14 items related to sensation. PSS scores are obtained by reversing the scores on the seven positive items, e.g., 0=4, 1=3, 2=2, etc., and then summing across all 14 items. Items 4, 5, 6, 7, 9, 10, and 13 are the positively stated items. A higher score indicates a higher level of Perceived Stress. The final score ranges from 0 to 56 points. Developed by Luft, 2007.	baseline; 1 week after intervention.