The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients

NCT04275830 | Completed

• 2 other identifiers: STUDY00010085PG12840
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing hematopoietic stem cell transplantation (HCT) often continue to experience anxiety, depression, isolation, and other psychosocial distress due to the severe nature of the transplant experience. Storytelling interventions that provide an opportunity for emotional disclosure have shown preliminary efficacy to alleviate psychosocial distress and improve emotion regulation during health challenges. Not only are these changes observed in response to such interventions, but they can also be directly strengthened with HRV biofeedback (HRVB) training, a device-driven breath pacing practice that uses colored light signals to provide feedback to increase vagal tone and improve emotional responses and sleep quality by regulating negative affect and stress. This randomized controlled trial will explore the effects of HRV biofeedback (HRVB) training combined with a digital storytelling intervention and changes in psychosocial distress with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients.

Conditions

Hematopoietic Stem Cell Transplantation; Bone Marrow Transplant; Heart Rate Variability; Autonomic Nervous System; Stress; Mood; Psychological Distress; Emotion Regulation; Communication Research; Narrative

Keywords

Digital Storytelling; Narrative; Cancer patients; Bone marrow transplant; Psychosocial health; Heart rate variability biofeedback

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline Heart Rate Variability (HRV and coherence scores) at 2 weeks

  The Emwave Pro Plus device from HeartMath will be used to collect HRV data and heart rate using a 3-minutes "neutral" protocol (we call "waiting at the bus stop" implying that no particular intent for breath or mindful state is to be evoked) to understand the benefits of DS+ HRVB. In addition, HRV measures will be obtained for the 1-minute paced breathing period to understand the effects of paced breathing on HRV. The following precautions will be provided as instructions to participants prior to data collection: no coffee, tea, or caffeinated drinks such as energizing drinks in the 2 hours before the data collection, and no alcohol consumption during 24 hours prior to the data collection.

  Baseline (T1), 2 weeks after (T2)

Secondary Outcomes (1)

• Changes from Baseline Profile of Mood States (POMS) short version (Psychological Distress) at 2 weeks

  Baseline (T1), 2 weeks after (T2)

Other Outcomes (1)

• Changes from Baseline Depression at 2 weeks

  Baseline (T1), 2 weeks after (T2)

Study Arms (2)

Baseline and HRVB+DS group

EXPERIMENTAL

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture before the random assignment to HRVB+DS arm. This group will receive a standardized HeartMath© Inner balance device and HRV biofeedback training session at the start of the two-week intervention period. They will be asked to attend either a group or one-on-one 30-minute HRVB training session and asked to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period. Participants will also be asked to watch four digital stories of other HCT patients (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each).

Behavioral: Baseline Surveys; Behavioral: Heart rate variability biofeedback

Baseline and HRVB waitlist +DS control group

OTHER

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture (REDCap) before the random assignment to HRVB waitlist +DS control arm. After the baseline data collection, during two weeks, they will be provided four digital stories of other HCT patients sharing their experiences (challenges, feelings, strategies, coping, each 2-3 minutes long). At the end of the two-week period, participants will be scheduled for a final in-person session including T2 survey and HRV assessment. They will be also provided HRVB training session at T2.

Behavioral: Baseline Surveys; Behavioral: Heart rate variability waitlist and Digital storytelling Control intervention

Interventions

Baseline Surveys BEHAVIORAL

Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.

Also known as: Baseline questionnaire

Baseline and HRVB waitlist +DS control group; Baseline and HRVB+DS group

Heart rate variability biofeedback BEHAVIORAL

Participants randomized to the intervention arm will receive exactly the same four digital stories via REDCap, a standardized HRV sensor and accompanying smart phone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be given a take-home manual and specifically asked to practice their HRVB skills at home for 5 minutes prior to viewing stories once each week and upload a log of their time practiced to the cloud. The main purpose of adding HRVB practice as a "priming" experience (i.e., to teach participants to practice HRV prior to viewing stories) is to optimize results by focusing patients' and caregivers' skills and experience on HRV as a mechanism of improved emotion regulation, and then combine this achieved coherent pattern with DS intervention.

Baseline and HRVB+DS group

Heart rate variability waitlist and Digital storytelling Control intervention BEHAVIORAL

Four Digital Stories Intervention (4 patient stories about hematopoietic cell transplantation (HCT) over the course of 2 weeks (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each). The 4 digital stories patients produced contained the following content: (1) a leukemia patient expressed and controlled her depression and anxiety and described how she dealt with the intensive treatment and recovery through a positive attitude and active coping; (2) a mother of 3 children, who was experiencing severe pain due to MS, coped with HCT through family support and positive reframing; (3) a lymphoma patient coped with the HCT procedures by praying during the treatment; and (4) a father of young twins had a HCT twice, and his wife helped him cope with emotional distress through open communication and expressing emotions.Participants will receive a 30-minute HRVB training session at T2.

Also known as: Narrative-based storytelling

Baseline and HRVB waitlist +DS control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• recently underwent Hematopoietic cell transplantation (HCT) (within 3 months after hospital discharge)
• must be able to speak, read, and write in English
• access to a working phone and e-mail account
• have a smart phone

You may not qualify if:

• cognitive impairment that prohibits completion of study assessment visual or hearing impairment
• other (e.g., provider non-approval or logistical constraints such as patient moving out of town)

Sponsors & Collaborators

• Arizona State University: lead
• HonorHealth Research Institute: collaborator

Study Sites (1)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Emotional Regulation; Narration

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Communication

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sunny Kim, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: February 4, 2020
• Primary Completion: December 31, 2021
• Study Completion: February 4, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

US (1)