Recruiting

Stress Management Program

Sponsor:

University of Pennsylvania

Code:

NCT07316478

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease

Study Details

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

Study ID

NCT07316478

Start date

Jan 15, 2026

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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.

Interventions

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.

Primary outcome measure

  • PROMIS-57 [ Time Frame: Baseline, 6 weeks, 3 month follow-up ]
  • ASCQ-Me [ Time Frame: Baseline, 6 weeks and 3 month follow-up ]

Central Contacts and Locations

Central contacts

Melissa G Hunt, PhD

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

Emery B Moore, High School Diploma

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Melissa Hunt, PhD

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

Sara Ugbana

6105298055sgugbana@sas.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-27.