Feasibilty and Acceptability of Amani
ConditionSickle Cell Disease
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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 and potentially other chronic illnesses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Have severe psychiatric (psychotic disorder, bipoloar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial
Trial design
Design model
Single group
Treatments tested in this trial
Amani
BehavioralAmani 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: AmaniExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility
Amani will be feasible if ≥50% of eligible patients enroll and if ≥60% of enrolled participants complete the educational modules and attend ≥60% of Amani group sessions.
Time frame
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)
Time frame
From enrollment to end of treatment (6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Ascent
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: