Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD)

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring how effective Acceptance and Commitment Therapy (ACT) can be for adults with sickle cell disease (SCD) who have trouble sleeping. ACT is a type of therapy that helps people accept their thoughts and feelings while committing to actions that improve their lives. The trial aims to see how well this therapy works and how participants feel about it. To join, you need to be between 18 and 55 years old, have a confirmed diagnosis of SCD, and experience sleep disturbances.

Participants in the trial will use their phones or computers to connect with a coach for weekly video sessions over 8 weeks. During these sessions, they will practice mindfulness exercises and learn about ACT. They'll also wear a special wrist device called an actigraph that tracks their movement and helps measure their sleep patterns. Each morning, participants will fill out a quick sleep diary, and they will complete surveys about their physical and emotional health throughout the study. This trial is conducted entirely online, so there's no need to travel to a clinic, making it easier for those interested to participate.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Ability of participant to understand and the willingness to sign a written informed consent document
• • Ability to read and speak English
• • Age \>=18 - \<= 55 years
• • Self-reported active diagnosis of Sickle Cell Disease
• • Must score a T-score of 57.5 or higher from the PROMIS Sleep Disturbance Scale
• • Self-reported sleep disturbance of at least 3 months
• • Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone or tablet with internet access and either a USB port or Bluetooth capability)
• • Must be willing to register online and install the software to use the actigraph and willing to complete the sleep diaries
• • Must be able and willing to attend remote ACT coaching calls during the study team s working hours
• EXCLUSION CRITERIA:
• • Uncontrolled psychiatric illness, cognitive impairments, or other circumstance as judged by the Principal Investigator (PI) or Lead Associate Investigator (LAI), both licensed psychologists, that would limit compliance with study requirements
• • Evidence of disease progression at the time of referral to this study to the extent that it would impede participation or completion of evaluations as determined by the medical advisory investigator in conjunction with the study PI/LAI
• • Individuals who are planning to start a new treatment or who are planning to change medications (e.g., pharmacological, dietary supplements, or psychological) for sleep disturbance or that have been known to significantly affect sleep in the next 6 months (Current sleep medication is not an exclusion criteria)
• • Individuals currently enrolled in a treatment protocol that would impact sleep
• • Previous treatment that cured sickle cell disease.
• • Individuals scheduled to receive gene therapy or stem cell therapy, or begin the conditioning regimen for these procedures, in the next 6 months