We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05457790
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Cell Anemia Insomnia Sleeplessness Transient Insomnia Nonorganic Insomnia Chronic Insomnia Behavioral: ACT Intervention Behavioral: Waitlist Not Applicable

Detailed Description:

Background:

  • Individuals with sickle cell disease (SCD) are faced with numerous challenges associated with their condition including sleep disturbance.
  • Actigraphy is a wearable data collection device using accelerometry to track real-time body movements and is able to document several important aspects of sleep.
  • Acceptance and Commitment Therapy (ACT) has been found effective in improving several aspects of health and wellbeing in individuals with chronic illness and pain, including sleep disturbance.
  • To our knowledge, ACT for sleep disturbance has not been investigated yet among individuals with SCD.

Objective:

To assess the feasibility and acceptability of an ACT for Sleep intervention in adults with SCD.

Eligibility:

  • Adults (>=18 - <=55) with a documented diagnosis of sickle cell disease.
  • Access to necessary resources for participating in a technology-based intervention (i.e., computer, tablet, or smartphone with internet access).
  • Enrolled on an NHLBI non-transplant protocol.
  • Must score a T-score of 57.5 or higher from the PROMIS(R) (Patient-Reported Outcomes Measurement Information System ) 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.
  • Ability to read and speak English.

Design:

  • This is a pilot randomized controlled trial (RCT) comparing participants who receive an 8-week ACT intervention (n = 15) with those in a wait-list control group (n = 15). We will aim to recruit three additional participants for each group to allow for dropouts, so our total target accrual is 36.
  • The study requires a 1-week baseline actigraphy data collection period followed by an 8-week ACT intervention period.
  • The intervention period includes weekly one-on-one 45-minute sessions with a psychologist or psychology associate over an NIH-approved telehealth platform.
  • Participants will wear an actigraphy monitor on non-dominant wrists during designated data collection periods. Participants also will complete measures on health and well-being (e.g., sleep, cognitive functioning, quality of life, and experiential avoidance) at preintervention, post intervention, and a 1-month follow-up assessment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : February 5, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024


Arm Intervention/treatment
Active Comparator: 1/Immediate Intervention Group
1-week baseline data collection period followed by an 8-week ACT intervention period focusing on acceptance, cognition defusion (i.e., not letting thoughts about sleep control behavior), present moment awareness, perspective taking, values, and committed actions.
Behavioral: ACT Intervention
1-week baseline data collection period followed by an 8-week ACT intervention period focusing on acceptance, cognition defusion (i.e., not letting thoughts about sleep control behavior), present moment awareness, perspective taking, values, and committed actions.

Active Comparator: 2/Waitlist Control Group
1-week baseline data collection period followed by 8 weeks of maintaining usual routine followed by an 8-week intervention focusing on acceptance, cognition defusion (i.e., not letting thoughts about sleep control behavior), present moment awareness, perspective taking, values, and committed actions.
Behavioral: Waitlist
1-week baseline data collection period followed by 8 weeks of maintaining usual routine followed by an 8-week intervention focusing on acceptance, cognition defusion (i.e., not letting thoughts about sleep control behavior), present moment awareness, perspective taking, values, and committed actions.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: Weeks 4, 8, and 12 ]
    (i) Treatment specific retention rate among all randomized participants, with a target retention rate of 70% over the 8-week intervention period (excluding those who are taken off study due to extended/frequent hospitalizations or disease complications). (ii) Compliance with at-home ACT practices per sleep diary, with a target of 4 days per week on average as assessed by a daily question during weeks 4, 8, and 12.

  2. Acceptability [ Time Frame: 4 Weeks post intervention ]
    Patient responses on the Acceptability questionnaire; a mean score >3.0 on items 1-4 will be deemed to reflect adequate satisfaction.


Secondary Outcome Measures :
  1. Relationships among sleep, pain, and quality of life at baseline. [ Time Frame: Baseline ]
    We will assess correlations between sleep variables (as described above), pain (PROMIS-57 pain scales), and the remaining PROMIS-57 quality of life subscales.

  2. Relationship between objective and subjective measures of sleep in SCD. [ Time Frame: Baseline, Weeks 4, 8, and 12 ]
    We will assess the correlations between sleep variables obtained with diaries and actigraphy (i.e., total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05457790


Contacts
Layout table for location contacts
Contact: Staci M Peron, Ph.D. (240) 760-6025 martins@mail.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)
Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT05457790    
Other Study ID Numbers: 10000423
000423-C
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 22, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Insomnia
Pain
Nonpharmacological
Actigraph
Anemia
Sleeplessness
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Dyssomnias
Parasomnias
Anemia, Sickle Cell
Anemia
Hematologic Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn