Using Acceptance and Commitment Therapy to Improve Sleep in Adults with Sickle Cell Disease
Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD): A Pilot Randomized Controlled Trial
This study is testing if a new therapy called Acceptance and Commitment Therapy can help adults with sickle cell disease sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05457790 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility and preliminary efficacy of Acceptance and Commitment Therapy (ACT) for addressing sleep disturbances in adults aged 18 to 55 with sickle cell disease (SCD). Participants will engage in weekly video sessions with an ACT coach for eight weeks, focusing on mindfulness exercises and ACT principles. The study will also utilize actigraphy to objectively measure sleep patterns and disturbances. The intervention is conducted remotely, allowing participants to join from home using internet-connected devices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with a self-reported diagnosis of sickle cell disease and experiencing sleep disturbances.
Not a fit: Patients with uncontrolled psychiatric illnesses or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall well-being for patients with sickle cell disease.
How similar studies have performed: While ACT has shown effectiveness in other chronic conditions, its application for sleep disturbances in sickle cell disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Staci M Peron, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: Staci M Peron, Ph.D.
- Email: martins@mail.nih.gov
- Phone: (240) 760-6025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.