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NCT Number: NCT07648043

Feasibilty and Acceptability of Amani

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility

    Time frame: From enrollment to end of treatment (6 weeks)

    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.

Secondary outcomes

  1. Acceptability

    Time frame: From enrollment to end of treatment (6 weeks)

    Amani will be acceptable if ≥80% enrolled patients report a System Usability Score ≥ 80 upon completion of the intervention (6 weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Richard A Newcomb, MD

CONTACT

[email protected]

617-726-2000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Ascent

Registry information

Official study title

Feasibilty and Acceptability of Amani, a Virtual Reality Application for Adults With Sickle Cell Disease

Acronym: Amani

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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