Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RCT of Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease
Overview
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.
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
Interventions
- 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.
Primary outcome measures
- PROMIS-57 [Time frame: Baseline, 6 weeks, 3 month follow-up]
- ASCQ-Me [Time frame: Baseline, 6 weeks and 3 month follow-up]
Secondary outcome measures (1)
- Beck Depression Inventory [Time frame: Baseline, 6 weeks and 3 month follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07316478 · 859513