Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease

NCT07316478 | Recruiting

• 1 other identifier: 859513
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; SCD; Mindfulness; Behavioral Health; stress management; cognitive behavioral therapy; deep diaphragmatic breathing; relaxation training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Beck Depression Inventory

  Baseline, 6 weeks and 3 month follow-up

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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.

Interventions

Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease BEHAVIORAL

This is a behavioral health intervention drawing from Cognitive Behavioral Therapy, Mindfulness Techniques, Relaxation Training and Assertiveness training.

Immediate Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Severe depression or suicidality

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Hemoglobin, Sickle

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hemoglobins, Abnormal; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Study Officials

• Melissa G Hunt, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa G Hunt, PhD

CONTACT

610-529-8055; mhunt@psych.upenn.edu

Emery B Moore, High School Diploma

CONTACT

317-604-3063; emerybm@sas.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Clinical Training

Model Details: Waitlist control followed by crossover to active treatment

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 5, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)