Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease

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: Recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa G Hunt, PhD; Phone Number: 610-529-8055; Email: mhunt@psych.upenn.edu
• Study Contact Backup: Name: Emery B Moore, High School Diploma; Phone Number: 317-604-3063; Email: emerybm@sas.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Melissa Hunt, PhD; Phone Number: 610-529-8055; Email: mhunt@psych.upenn.edu
      • Contact: Sara Ugbana; Phone Number: 6105298055; Email: sgugbana@sas.upenn.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
PROMIS-57	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	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

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	Standard multiple choice measure of depressive symptoms	Baseline, 6 weeks and 3 month follow-up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Melissa G Hunt, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; cognitive behavioral therapy; sickle cell disease; Behavioral Health; SCD; stress management; relaxation training; deep diaphragmatic breathing
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Amino Acids, Peptides, and Proteins; Proteins; Blood Proteins; Hemeproteins; Hemoglobins; Globins; Hemoglobins, Abnormal; Hemoglobin, Sickle
• Other Study ID 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