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

Insomnia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Chronic Insomnia
• Dyssomnias
• Insomnia
• Nonorganic Insomnia
• Parasomnias
• Sickle Cell Anemia
• Sickle Cell Disease
• Sleep Initiation and Maintenance Disorders
• Sleeplessness
• Transient Insomnia

• NCT number: NCT05457790
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Staci M Peron, Ph.D.
• Phone: (240) 760-6025
• Email: martins@mail.nih.gov
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2024
• Completion date: July 31, 2024