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Not yet recruiting NCT07648043

Feasibility and Acceptability of Amani

Phase I / Phase II Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amani.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Amani
    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 outcome measures

  • Feasibility [Time frame: From enrollment to end of treatment (6 weeks)]
Secondary outcome measures (1)
  • Acceptability [Time frame: From enrollment to end of treatment (6 weeks)]

Eligibility criteria

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, bipolar disorder) or cognitive impairment which the treating hematologist believes would preclude ability to participate in the clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07648043 · 26-307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗