CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Acceptance and Commitment Therapy (ACT)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04423939
NCT04423939N/ACompleted

ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients

Duke University·interventional·Posted Jun 9, 2020·Updated Nov 25, 2025

In Brief

A clinical study evaluating Acceptance and Commitment Therapy (ACT) for Hematopoietic Steam Cell Transplantation (HCT). Completed, enrolled 33 participants across 1 site.

Detailed Summary

This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 9, 2020
Enrollment StartOct 14, 2020
Primary CompletionMay 19, 2022
Study CompletionFeb 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.1 years ago

Interventions

Acceptance and Commitment Therapy (ACT)behavioral

The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.