NCT02257853

Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

Completed Phase 2 Last updated 20 March 2026

What this trial tests

Phase 2 trial testing Stress reduction intervention in Stress, Psychological in 53 participants. Completed in 7 February 2019.

Timeline

5 January 2015

Primary endpoint
8 November 2018

7 February 2019

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	5 January 2015
Primary completion	8 November 2018
Estimated completion	7 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Stress reduction intervention

Conditions studied

• Stress, Psychological — all drugs for Stress, Psychological →
• Caregivers — all drugs for Caregivers →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

18 and older, any sex, with Stress, Psychological or Caregivers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they recover. Being a caregiver can be stressful to the body and mind. Researchers want to find ways to reduce this stress.

Objective:

\- To see how a stress reduction intervention affects the stress levels and health of an HSCT caregiver.

Eligibility:

\- Adults age 18 and older who plan to be an active caregiver for a person having their first allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring for the person from just before admission for the HSCT until at least 6 weeks after.

Design:

* Participants will be put in either the intervention group or the control group.
* All participants will get the usual caregiver education given to all patients and caregivers having a stem cell transplant at the NIH Clinical Center.
* All participants will have 2 study visits. They will give blood samples. They will have health assessments and brief physical exams. They will fill out study questionnaires and have an exit interview.
* The intervention group will get an MP3 player. It will have an audio file with a stress reduction intervention on it. Participants will do this intervention daily. It takes 20 minutes. They will do gentle stretches and breathing exercises. They will get a diary to track their practice.
* The intervention group also will have follow-up phone calls 2 and 4 weeks after their first clinic visit.
* The person getting the HSCT will not be actively involved in the study.
* The study will last about 2 months.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a yoga-based stress reduction intervention on stress, psychological outcomes and cardiometabolic biomarkers in cancer caregivers: A randomized controlled trial.
   Lee LJ, Shamburek R, Son H, Wallen GR, et al · · 2022 · cited 12× · PMID 36355827 · DOI 10.1371/journal.pone.0277009
2. Factors associated with inflammatory cytokines in family caregivers of allogeneic hematopoietic stem cell transplantation (HSCT) recipients.
   Lee LJ, Barb JJ, Son EH, Yang L, et al · · 2025 · cited 1× · PMID 40216094 · DOI 10.1016/j.bbi.2025.04.013