This study is currently recruiting participants.
Number
000423-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 55 Years
Referral Letter Required
No
Population Exclusion(s)
Non-English Speaking;Children
Keywords
Insomnia; Pain; Nonpharmacological; Actigraph; Anemia; Sleeplessness
Recruitment Keyword(s)
None
Condition(s)
Sickle Cell Disease; Sickle Cell Anemia; Insomnia; Sleeplessness; Transient Insomnia; Nonorganic Insomnia; Chronic Insomnia
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Behavioral: ACT Intervention Behavioral: Waitlist
Supporting Site
National Cancer Institute
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.
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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 -Documented active diagnosis of Sickle Cell Disease per medical record -Enrolled on an NHLBI non-transplant protocol -Must score a T-score of 57.5 or higher from the PROMIS Sleep Disturbance Scale OR respond with "dissatisfied" or "very dissatisfied" to item #4 on the Insomnia Severity Index that asks about satisfaction with current sleep pattern -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. 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 5 months (Current sleep medication is not an exclusion criteria) -Individuals currently enrolled in a treatment protocol that would impact sleep
-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
-Documented active diagnosis of Sickle Cell Disease per medical record
-Enrolled on an NHLBI non-transplant protocol
-Must score a T-score of 57.5 or higher from the PROMIS Sleep Disturbance Scale OR respond with "dissatisfied" or "very dissatisfied" to item #4 on the Insomnia Severity Index that asks about satisfaction with current sleep pattern
-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.
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 5 months (Current sleep medication is not an exclusion criteria)
-Individuals currently enrolled in a treatment protocol that would impact sleep
Principal Investigator
Referral Contact
For more information: