Clinical trial NCT05457790: Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Sickle Cell Anemia
Insomnia
Sleeplessness
Transient Insomnia
Nonorganic Insomnia
Chronic Insomnia
Keywords: Insomnia
Pain
Nonpharmacological
Actigraph
Anemia
Sleeplessness
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2022-07-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 self-reported 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).
* Must score a T-score of 57.5 or higher from the PROMIS(R) (Patient-Reported Outcomes Measurement Information System(R) Sleep Disturbance Scale.
* 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 approximately 60-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.

Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: Weeks 4, 8, and 12
measure: Acceptability
timeFrame: 4 Weeks post intervention
Secondary outcomes:
measure: Relationships among sleep, pain, and quality of life at baseline.
timeFrame: Baseline
measure: Relationship between objective and subjective measures of sleep in SCD.
timeFrame: Baseline, Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Staci M Peron, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: