Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease

February 25, 2026 updated by: Melissa Hunt, PhD, University of Pennsylvania

RCT of Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease

The purpose of this research is to determine whether a new stress management and mindfulness program can improve quality of life in individuals with sickle cell disease. The program is based on a number of empirically supported treatments including techniques from cognitive-behavioral therapy like overcoming motivational barriers to self-care, learning to see things as accurately as possible, practicing assertive communication, relaxation exercises like deep slow breathing, mindfulness meditation, and other stress management strategies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After consenting and completing the baseline measures, participants will be assigned (like flipping a coin) to the immediate treatment group or the control group. The immediate treatment group will participate in the intervention for six weeks while the control group waits. At the end of six weeks, both groups will complete the measures again, and then the control group will have a chance to participate in the intervention. See table below for the timeline of the study for each group.

Study Stage Immediate Intervention Group Waitlist Control Group

  1. Baseline Measures - Complete online demographic, mood, and symptom questionnaires

    • May skip any questions
    • Study team emails to confirm participation Same as Immediate Group
  2. Randomization (like flipping a coin) Receive email stating you were assigned to the Immediate Group and will begin the program right away Receive email stating you were assigned to the Waitlist Group and will begin the program after 6 weeks Weeks 1-6 Attend six weekly 1-hour group sessions (in person on the campus of the University of Pennsylvania in room 450 of the NBS building located at 425 S. University Avenue or via Zoom) Waiting period (no sessions yet) End of Week 6 Complete symptom measures again and provide feedback on the program Complete symptom measures at the end of the waiting period Weeks 7-12 No additional sessions during this time Attend six weekly 1-hour group sessions (in person in NBS 450 or via Zoom) End of Week 12 - Complete symptom measures again and provide feedback on the program Final Follow-Up (3 months after completing the program) Complete the symptom questionnaires one last time Complete the symptom questionnaires one last time

Intervention: The intervention is a stress management and mindfulness-based program developed and led by Dr. Melissa Hunt, who is a licensed clinical psychologist with expertise in chronic health conditions and mindfulness interventions. She will be assisted by four research coordinators who are undergraduate psychology majors at the University of Pennsylvania. Participants will also have access to an app called Blackfulness. It is a mindfulness meditation app designed specifically for black people. The in person sessions will take place in person at The Neural and Behavioral Sciences (NBS) Building (425 S University Ave, Philadelphia, PA 19104) Room 450. Remote sessions will take place virtually via Zoom video conferencing. People who elect the in person sessions may choose to attend some sessions remotely if weather or health necessitates it.

Week Focus Goals

1 Stress, Health, and Pain Education • Learn how psychological stress affects health and SCD pain crises

  • Learn deep diaphragmatic breathing and basic relaxation skills to lower stress and improve pain management 2 Cognitive Therapy Skills • Learn CBT techniques to rethink situations, reduce stress, and respond less reactively
  • Practice identifying unhelpful thoughts and replacing them with more balanced ones 3 Self-Care & Barriers to Change • Explore self-care strategies (sleep, exercise, wellness habits)
  • Discuss barriers to self-care and ambivalence about change
  • Learn ways to build more wellness activities into daily life. 4 Navigating the ER & Medical Encounters • Learn effective ways to communicate with doctors and nurses unfamiliar with SCD
  • Review suggested scripts and role-play interactions with medical personnel
  • Practice advocacy skills to make sure your voice is heard 5 Mindfulness Meditation I • Introduction to mindfulness practices that decrease emotional and physical reactivity
  • Build self-compassion skills
  • Optional use of the Blackfulness app for between-session practice (requires agreeing to the app's privacy policies) 6 Mindfulness Meditation II & Mindful Movement • Continue mindfulness practice, including gentle mindful movement and stretching
  • Learn ways to integrate mindfulness into daily routines

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosed with sickle cell disease.
  • Live within 90 minutes of Philadelphia

Exclusion Criteria:

- Severe depression or suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Treatment

6 week intervention focused on: How psychological stress affects health and SCD pain crises Deep diaphragmatic breathing and basic relaxation skills to lower stress and improve pain management CBT techniques to rethink situations, reduce stress, and respond less reactively Practice identifying unhelpful thoughts and replacing them with more balanced ones Self-Care & Barriers to Change Learn ways to build more wellness activities into daily life.

Navigating the ER & Medical Encounters. Learn effective ways to communicate with doctors and nurses unfamiliar with SCD Mindfulness Meditation
Behavioral: Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease
This is a behavioral health intervention drawing from Cognitive Behavioral Therapy, Mindfulness Techniques, Relaxation Training and Assertiveness training.
No Intervention: Waitlist Control
Participants in the waitlist control will receive no treatment for 6 weeks. After completing the follow-up measures, they will be crossed over to active treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PROMIS-57
Time Frame: Baseline, 6 weeks, 3 month follow-up
PROMIS-57 Profile (PROMIS Health Organization, 2020) offers a broad assessment of health-related quality of life (HRQoL) across multiple domains such as physical function, anxiety, depression, fatigue, and sleep disturbance
Baseline, 6 weeks, 3 month follow-up
ASCQ-Me
Time Frame: Baseline, 6 weeks and 3 month follow-up
Quality of life in adults with SCD is comprehensively measured by the ASCQ-Me tool (ASCQ-Me User's Manual, American Institutes for Research, 2017), covering emotional distress, pain impact, and sleep disturbances, and validated for use in both clinical and research settings. We will be using the Pain Impact Scale (ASCQ-Me v2.0 Pain Impact - American Institutes for Research, 2017) which assesses how much pain limits daily activities and overall function.
Baseline, 6 weeks and 3 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: Baseline, 6 weeks and 3 month follow-up
Standard multiple choice measure of depressive symptoms
Baseline, 6 weeks and 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa G Hunt, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 859513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To reduce risk of breach of confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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