Cognitive Behavioral Therapy for Bone Marrow Transplant Recovery

No longer recruiting at 1 trial location

Overseen By Lauren Hill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Under 18, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Acceptance and Commitment Therapy (ACT) can assist individuals recovering from a bone marrow transplant, particularly those who have undergone hematopoietic stem cell transplants (HCT). The goal is to alleviate the physical and mental challenges patients encounter during recovery. Participants will engage in therapy sessions, participate in physical and cognitive tests, and use technology like iPads and Apple Watches to monitor their progress. This study is ideal for English-speaking adults undergoing HCT who have a caregiver willing to participate. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance recovery experiences for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this protocol is safe for HCT patients?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally easy for patients to handle. Studies have found that both stem cell transplant patients and their caregivers find ACT manageable and are willing to continue with it.

No major reports of negative side effects from ACT have emerged in these groups. The therapy supports mental health and improves physical function, which can greatly benefit those recovering from a stem cell transplant.

Overall, ACT appears to be a safe option for enhancing the recovery experience after a stem cell transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for bone marrow transplant recovery because it offers a fresh psychological approach that focuses on mental resilience. Unlike traditional therapies that may primarily address physical symptoms, ACT aims to help patients accept their thoughts and feelings while committing to personal values, which can be crucial during challenging recovery periods. This method is particularly promising because it empowers both patients and caregivers, potentially improving emotional well-being and overall recovery experiences.

What evidence suggests that this protocol is effective for bone marrow transplant recovery?

Research has shown that Acceptance and Commitment Therapy (ACT) could benefit individuals undergoing a hematopoietic stem cell transplant (HCT). In this trial, one group will include HCT patients, while another will consist of their caregivers. Studies suggest that ACT might enhance physical abilities post-transplant, which is crucial for recovery. It also aids patients in managing the emotional and mental stress of the transplant process. Although further research is needed to confirm all its benefits, early results indicate that ACT is both acceptable and potentially helpful for these patients. ^{2 3 4 5 6}

Who Is on the Research Team?

Anthony Sung, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing allogeneic hematopoietic stem cell transplant (HCT) for cancer or other illnesses, and speak English. They must have a caregiver willing to participate. It's not open to those under 18, without an English-speaking caregiver, or non-English speakers themselves.

Inclusion Criteria

Patient has a caregiver willing to participate

I am over 18 years old.

Patient is English speaking

Exclusion Criteria

My caregiver is not willing to participate in the study.

Patient is non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in acceptance and commitment therapy (ACT), complete physical and cognitive tests, and use iOS devices and activity trackers. They also provide various biological samples for analysis.

3 years

Multiple visits (in-person and virtual) throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of physical function, mental health, and quality of life.

3 years

Regular assessments at Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy (ACT)

Trial Overview The study tests acceptance and commitment therapy (ACT) to reduce complications in HCT patients. Participants will undergo ACT sessions, physical and cognitive tests, learn to use iOS devices and activity trackers for monitoring, complete surveys on emotional/cognitive function and provide stool samples as well as skin swabs.

How Is the Trial Designed?

Group I: Hematopoietic Stem Cell Transplantation (HCT) Patients Experimental Treatment 1 Intervention

20 HCT patients at Duke

Group II: Caregivers Experimental Treatment 1 Intervention

20 HCT patients caregivers at Duke

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888137/

PMC - PubMed Central Conclusion: ACT is an acceptable and potentially useful intervention for individuals undergoing HCT. Additional controlled studies are warranted ...

2. astctjournal.org astctjournal.org/article/S2666-6367(24)00005-8/fulltext

Acceptance and Commitment Therapy May Improve ... Acceptance and Commitment Therapy May Improve Physical Function after Allogeneic Hematopoietic Stem Cell Transplant. Jordan Infield, MD. Jordan Infield, MD.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11186126/

study protocol for a randomized controlled trial enhanced ... This trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT.

4. psychiatry-psychopharmacology.com psychiatry-psychopharmacology.com/Content/files/sayilar/138/PCP_20240947_nlm_new_indd(1).pdf

Effects of Acceptance and Commitment Care in the ... ABSTRACT. Background: This study was designed to determine the effects of acceptance and commitment care in the treatment of aplastic anemia ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06266182

The Effect of an Online ACT Intervention on Meaning ... This trial evaluates the feasibility, acceptability, and preliminary efficacy of self-help internet-based Acceptance and Commitment Therapy (ACT) intervention ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/?term=Acceptability+and+feasibility+of+acceptance+and+commitment+therapy+for+improving+outcomes+in+hematopoietic+stem+cell+transplant

Acceptability and feasibility of acceptance and commitment ... The aim of the current study was to examine whether a brief Acceptance and Commitment Therapy (ACT) intervention is acceptable to HCT patients and caregivers.