SUSPENDED

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

Conditions

Sickle Cell Disease Sickle Cell Anemia Insomnia Sleeplessness Transient Insomnia Nonorganic Insomnia Chronic Insomnia Pain Nonpharmacological Actigraph Anemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Research Type: Clinical Trial Background: People with sickle cell disease (SCD) have many health challenges. Also, they often have trouble sleeping. Acceptance and commitment therapy (ACT) might help people with SCD to improve their sleep problems. Objective: To see how well ACT works in people with SCD and sleep problems and to find out how they feel about it. Eligibility: People between the ages of 18 and 55 with SCD and trouble sleeping. Design: The study is remote. Participants will not have to come to the NIH at all. They will need a device that has Bluetooth and can connect to the internet. Some participants will be in the study for 12 weeks. Others will participate for 20 weeks. Participants will video chat with an ACT coach once a week for 8 weeks. The coach will guide participants through mindfulness exercises and teach ACT ideas. Each session lasts about 45 minutes. Participants will be loaned an actigraph, a device worn on the wrist like a watch that measures and records movement. They will download a free app to upload data from the actigraph for the researchers. Participants will wear the actigraph on their nondominant wrist day and night for either 4 or 6 designated weeks. During these weeks, participants will complete a sleep diary each morning when they wake up. This takes about 2 minutes. Participants will be sent other surveys to complete from home during the study. They will answer questions about their physical and emotional health. These take 20-25 minutes. The last survey will be 4 weeks after participants finish the ACT treatment. They will answer questions about how helpful they thought ACT was and how easy or hard it was to wear the actigraph.

Official Title

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

Quick Facts

Study Start:2024-05-03

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05457790

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Staci M Peron, Ph.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Staci M Peron, Ph.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-05-03

Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

Insomnia
Pain
Nonpharmacological
Actigraph
Anemia
Sleeplessness

Additional Relevant MeSH Terms

Sickle Cell Disease
Sickle Cell Anemia
Insomnia
Sleeplessness
Transient Insomnia
Nonorganic Insomnia
Chronic Insomnia