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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Sickle Cell Disease; Sickle Cell Anemia; Sleeplessness; Transient Insomnia; Nonorganic Insomnia; Chronic Insomnia
• Intervention / Treatment: Behavioral: ACT Intervention; Behavioral: Waitlist

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(R) 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 four one-on-one 45-55-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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Staci M Peron, Ph.D.; Phone Number: (240) 760-6025; Email: martins@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office; Phone Number: 888-624-1937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	(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.	Weeks 4, 8, and 12
Acceptability	Patient responses on the Acceptability questionnaire; a mean score >3.0 on items 1-4 will be deemed to reflect adequate satisfaction.	4 Weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationships among sleep, pain, and quality of life at 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.	Baseline
Relationship between objective and subjective measures of sleep in SCD.	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).	Baseline, Weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Staci M Peron, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Estimated): April 23, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: February 23, 2024

More Information

Terms related to this study

• Keywords: Pain; Anemia; Insomnia; Nonpharmacological; Actigraph; Sleeplessness
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Anemia, Sickle Cell
• Other Study ID Numbers: 10000423; 000423-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No