Feasibilty and Acceptability of Amani

NCT07648043 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 26-307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; virtual reality; non-pharmacologic analgesia; social support; coping

Outcome Measures

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.

  From enrollment to end of treatment (6 weeks)

Secondary Outcomes (1)

• Acceptability

  From enrollment to end of treatment (6 weeks)

Study Arms (1)

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

Behavioral: Amani

Interventions

Amani BEHAVIORAL

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.

Amani

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have severe psychiatric (psychotic disorder, bipoloar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Ascent: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 01867, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Richard A Newcomb, MD

CONTACT

617-726-2000; richard.newcomb@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-05

Locations

US (1)