1/Immediate Intervention Group for Transient Insomnia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Transient Insomnia+9 More
Waitlist - Behavioral
Eligibility
18 - 65
All Sexes
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Study 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.

Eligible Conditions

  • Transient Insomnia
  • Sickle Cell Disease (SCD)
  • Nonorganic Insomnia
  • Insomnia
  • Sickle Cell Anemia
  • Insomnia Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline

4 Weeks post intervention
Acceptability
Baseline
Relationships among sleep, pain, and quality of life at baseline.
Week 4
Relationship between objective and subjective measures of sleep in SCD.
Week 4
Feasibility

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

1/Immediate Intervention Group
1 of 2
2/Waitlist Control Group
1 of 2
Active Control

36 Total Participants · 2 Treatment Groups

Primary Treatment: 1/Immediate Intervention Group · No Placebo Group · N/A

1/Immediate Intervention Group
Behavioral
ActiveComparator Group · 1 Intervention: ACT Intervention · Intervention Types: Behavioral
2/Waitlist Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Waitlist · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
1 TrialsResearching Transient Insomnia
270 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to understand the nature and purpose of the study and the potential risks and benefits of participating in the study.
You have a score of 57.5 or higher on the PROMIS Sleep Disturbance Scale
You have access to a technology-based intervention (i.e., computer, smartphone or tablet with internet access and either a USB port or Bluetooth capability).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.