Sickle Cell DiseaseNCT07316478
Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease
A study testing Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease in people with Sickle Cell Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Diagnosed with sickle cell disease.
- Live within 90 minutes of Philadelphia
Who cannot join
- Severe depression or suicidality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Melissa Hunt, PhD, 610-529-8055, mhunt@psych.upenn.edu
Sara Ugbana, 6105298055, sgugbana@sas.upenn.edu
About this study
Official title: 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.
Read the 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
- Baseline Measures - Complete online demographic, mood, and symptom questionnaires
- May skip any questions
- Study team emails to confirm participation Same as Immediate Group
- 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
- Conditions
- Sickle Cell Disease
- Being tested
- Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease
- Keywords
- sickle cell disease, SCD, Mindfulness, Behavioral Health, stress management, cognitive behavioral therapy, deep diaphragmatic breathing, relaxation training
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Mindfulness Intervention for Patients with Sickle Cell DiseaseBehavioural
This is a behavioral health intervention drawing from Cognitive Behavioral Therapy, Mindfulness Techniques, Relaxation Training and Assertiveness training.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, 6 weeks and 3 month follow-up
Secondary outcomes (1)
Beck Depression Inventory
Standard multiple choice measure of depressive symptoms
Measured: Baseline, 6 weeks and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start15 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist control followed by crossover to active treatment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Hunt, PhD, University of Pennsylvania
- Investigators
- Melissa G Hunt, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316478
- Sponsor's protocol ID
- 859513
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To reduce risk of breach of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07316478
- Acronym / sponsor ID
- 859513
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, SCD, Mindfulness, Behavioral Health, stress management, cognitive behavioral therapy, deep diaphragmatic breathing, relaxation training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Baseline Measures - Complete online demographic, mood, and symptom questionnaires
- May skip any questions
- Study team emails to confirm participation Same as Immediate Group
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control followed by crossover to active treatment
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease6 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older.
- Diagnosed with sickle cell disease.
- Live within 90 minutes of Philadelphia
Key exclusion criteria (1 listed)
- Severe depression or suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Management and Mindfulness Intervention for Patients with Sickle Cell DiseaseThis is a behavioral health intervention drawing from Cognitive Behavioral Therapy, Mindfulness Techniques, Relaxation Training and Assertiveness training. | Behavioural | Immediate Treatment |
Primary outcome
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
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.
1 secondary outcome
Beck Depression Inventory
Time frame: Baseline, 6 weeks and 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. To reduce risk of breach of confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa G Hunt, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and Mindfulness Intervention for Patients with Sickle Cell Disease in people with Sickle Cell Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa G Hunt, PhD (610-529-8055, mhunt@psych.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS-57 (time frame: Baseline, 6 weeks, 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.