Sickle Cell DiseasePhase 1/2AmaniNCT07648043
Feasibility and Acceptability of Amani
A Phase 1/2 study testing Amani in people with Sickle Cell Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Adults with sickle cell disease (SCD) experience severe pain, emotional distress, and social isolation that diminish their quality of life. This project will test Amani, a novel virtual reality supportive care intervention designed to improve coping skills and strengthen peer support. 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?
- Amani
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Phase 1/2
- 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
- Adults (≥ 18 years) who are diagnosed with sickle cell disease
- Primarily followed at the Massachusetts General Hospital (MGH) Sickle Cell Disease Center
- Have ability to comprehend and speak English given Amani is currently only available in English.
Who cannot join
- Have severe psychiatric (psychotic disorder, bipolar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial
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
Massachusetts General Hospital
Boston, Massachusetts, 01867
Richard Newcomb, MD, 617-726-2000, richard.newcomb@mgh.harvard.edu
richard.newcomb@mgh.harvard.edu
About this study
Official title: Feasibilty and Acceptability of Amani, a Virtual Reality Application for Adults With Sickle Cell Disease
Adults with sickle cell disease (SCD) experience severe pain, emotional distress, and social isolation that diminish their quality of life. This project will test Amani, a novel virtual reality supportive care intervention designed to improve coping skills and strengthen peer support. If feasible and acceptable, Amani offers an accessible digital supportive care intervention to improve psychological well-being and quality of life among individuals living with SCD.
- Conditions
- Sickle Cell Disease
- Being tested
- Amani
- Keywords
- sickle cell disease, virtual reality, non-pharmacologic analgesia, social support, coping
- 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.
AmaniBehavioural
Amani is a multi-component VR supportive care intervention specifically tailored for adults with SCD. Amani integrates mindfulness-based pain management exercises, psychoeducational modules to build adaptive coping strategies, and facilitated VR group sessions to reduce isolation and foster peer support.
| Study group | Role | What they receive |
|---|---|---|
| Amani | Experimental | Patients enrolled will receive Amani, which is a virtual reality intervention administered over 5 weeks. Amani is a virtual reality based supportive care intervention specifically tailored for adults with SCD. Amani integrates mindfulness-based pain management exercises, psychoeducational modules to build adaptive coping strategies, and facilitated group sessions in virtual reality to reduce isolation and foster peer support Receives: Behavioral: Amani |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Amani will be feasible based on proportion of eligible patients enrolled (≥50% of eligible patients enroll), application educational module completion (≥60% of enrolled participants complete the educational modules) and group intervention attendance (≥60% of Amani group sessions).
Measured: From enrollment to end of treatment (6 weeks)
Secondary outcomes (1)
Acceptability
Amani will be acceptable if ≥80% enrolled patients report a System Usability Score ≥ 80 upon completion of the intervention (6 weeks)
Measured: From enrollment to end of treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Jun 2028 (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 Massachusetts General HospitalThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ascent
- Responsible party
- Principal investigator, Richard Andrew Newcomb, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648043
- Sponsor's protocol ID
- 26-307
- Acronym
- Amani
- Status last verified
- May 2026
- First submitted
- 9 Jun 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing requests will be considered on an individual basis and should be emailed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibilty and Acceptability of Amani, a Virtual Reality Application for Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07648043
- Acronym / sponsor ID
- Amani / 26-307
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, virtual reality, non-pharmacologic analgesia, social support, coping
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ascent
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jun 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.
Adults with sickle cell disease (SCD) experience severe pain, emotional distress, and social isolation that diminish their quality of life. This project will test Amani, a novel virtual reality supportive care intervention designed to improve coping skills and strengthen peer support. If feasible and acceptable, Amani offers an accessible digital supportive care intervention to improve psychological well-being and quality of life among individuals living with SCD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amani | Experimental | Behavioral: AmaniPatients enrolled will receive Amani, which is a virtual reality intervention administered over 5 weeks. Amani is a virtual reality based supportive care intervention specifically tailored for adults with SCD. Amani integrates mindfulness-based pain management exercises, psychoeducational modules to build adaptive coping strategies, and facilitated group sessions in virtual reality to reduce isolation and foster peer support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥ 18 years) who are diagnosed with sickle cell disease
- Primarily followed at the Massachusetts General Hospital (MGH) Sickle Cell Disease Center
- Have ability to comprehend and speak English given Amani is currently only available in English.
Key exclusion criteria (1 listed)
- Have severe psychiatric (psychotic disorder, bipolar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial
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 |
|---|---|---|
| AmaniAmani is a multi-component VR supportive care intervention specifically tailored for adults with SCD. Amani integrates mindfulness-based pain management exercises, psychoeducational modules to build adaptive coping strategies, and facilitated VR group sessions to reduce isolation and foster peer support. | Behavioural | Amani |
Primary outcome
Feasibility
Time frame: From enrollment to end of treatment (6 weeks)
Amani will be feasible based on proportion of eligible patients enrolled (≥50% of eligible patients enroll), application educational module completion (≥60% of enrolled participants complete the educational modules) and group intervention attendance (≥60% of Amani group sessions).
1 secondary outcome
Acceptability
Time frame: From enrollment to end of treatment (6 weeks)
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 7 Aug 2026.
- Individual participant dataSharing planned: Undecided. Data sharing requests will be considered on an individual basis and should be emailed to the principal investigator.
Related trials for Sickle Cell Disease
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
Active, not recruitingObservational study
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
Sickle Cell Anemia, Sickle Cell Thalassemia
Enrolling by invitationPhase 4
A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
Pyruvate Kinase Deficiency, Anemia, Hemolytic
Active, not recruitingPhase 2
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Sickle Cell Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amani in people with Sickle Cell Disease, run by Massachusetts General Hospital 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: opening soon, as of the sponsor's last update on 7 Aug 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Richard A Newcomb, MD (617-726-2000, richard.newcomb@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From enrollment to end of treatment (6 weeks)). 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 7 Aug 2026.