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ACT for Sleep Disturbances in Sickle Cell Disease

N/A
Recruiting
Led By Staci M Peron, Ph.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial is testing how well ACT works in people with sickle cell disease and sleep problems.

Who is the study for?
This trial is for adults aged 18-55 with Sickle Cell Disease (SCD) who have sleep problems. They must be able to read and speak English, give informed consent, have internet access with a compatible device, and be willing to use an actigraph. People with uncontrolled psychiatric illnesses or cognitive impairments that affect study compliance are excluded.Check my eligibility
What is being tested?
The trial tests Acceptance and Commitment Therapy (ACT) for improving sleep in people with SCD. It's remote; participants video chat weekly with an ACT coach for 8 weeks while wearing an actigraph to monitor sleep patterns. Surveys on health will also be completed during the study period.See study design
What are the potential side effects?
Since this is a therapy-based intervention focusing on mindfulness exercises without medication, there are no direct side effects like those associated with drugs. However, discomfort from wearing the actigraph or emotional distress from discussing personal issues may occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Feasibility
Secondary outcome measures
Relationship between objective and subjective measures of sleep in SCD.
Relationships among sleep, pain, and quality of life at baseline.

Trial Design

2Treatment groups
Active Control
Group I: 1/Immediate Intervention GroupActive Control1 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.
Group II: 2/Waitlist Control GroupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,926,037 Total Patients Enrolled
Staci M Peron, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
7 Previous Clinical Trials
465 Total Patients Enrolled

Media Library

ACT Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05457790 — N/A
Sickle Cell Disease Research Study Groups: 1/Immediate Intervention Group, 2/Waitlist Control Group
Sickle Cell Disease Clinical Trial 2023: ACT Intervention Highlights & Side Effects. Trial Name: NCT05457790 — N/A
ACT Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific research open to participants of all ages, including young adults?

"This study only permits those between 18 and 55 years old to join. For individuals younger than the age of consent, 181 studies are available while 344 trials can be accessed by seniors over 65."

Answered by AI

To whom is this clinical research open for participation?

"In order to be accepted into this medical trial, sufferers of transient insomnia aged 18 - 55 should apply. This research is expecting a total of 36 participants."

Answered by AI

Are there any current opportunities to enroll in this experiment?

"Evidently, this trial is no longer active as evidenced by its listing on clinicaltrials.gov; with the first posting on December 1st 2022 and last edited November 25th 2022. However, there are 536 other medical studies that are actively seeking participants at the moment."

Answered by AI
~24 spots leftby Jul 2024