Sickle Cell DiseaseNCT05457790
Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD)
A study testing ACT Intervention and Waitlist in people with Sickle Cell Disease and Sickle Cell Anemia, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Anemia, Insomnia
- What is being tested?
- ACT Intervention and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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
Research Type: Clinical Trial
Background:
Read more
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia, Insomnia, Sleeplessness, Transient Insomnia, Nonorganic Insomnia
- Being tested
- ACT Intervention, Waitlist
- Keywords
- Insomnia, Pain, Nonpharmacological, Actigraph, Anemia, Sleeplessness
- Medical subject headings
- Anemia, Sickle Cell, Sleep Initiation and Maintenance Disorders, Pain, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT InterventionBehavioural
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.
WaitlistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1/Immediate Intervention Group | Active comparator | 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. Receives: Behavioral: ACT Intervention |
| 2/Waitlist Control Group | Active comparator | 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. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 Weeks post intervention
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline, Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start3 May 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Why it stopped: Study on hold pending consideration for amendment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Staci M Peron, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457790
- Sponsor's protocol ID
- 10000423
- Other IDs
- 000423-C
- Status last verified
- 18 Nov 2025
- First submitted
- 12 Jul 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05457790
- Acronym / sponsor ID
- 10000423
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia, Insomnia, Sleeplessness, Transient Insomnia, Nonorganic Insomnia
- Keywords
- Insomnia, Pain, Nonpharmacological, Actigraph, Anemia, Sleeplessness
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study on hold pending consideration for amendment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 May 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Immediate Intervention Group | Active comparator | Behavioral: ACT Intervention1-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. |
| 2/Waitlist Control Group | Active comparator | Behavioral: Waitlist1-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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT Intervention1-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. | Behavioural | 1/Immediate Intervention Group |
| Waitlist1-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. | Behavioural | 2/Waitlist Control Group |
Primary outcome
Feasibility
Time frame: Weeks 4, 8, and 12
(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.
Acceptability
Time frame: 4 Weeks post intervention
Patient responses on the Acceptability questionnaire; a mean score >3.0 on items 1-4 will be deemed to reflect adequate satisfaction.
2 secondary outcomes
Relationships among sleep, pain, and quality of life at baseline.
Time frame: Baseline
Relationship between objective and subjective measures of sleep in SCD.
Time frame: Baseline, Weeks 4, 8, and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staci M Peron, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Intervention and Waitlist in people with Sickle Cell Disease and Sickle Cell Anemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Weeks 4, 8, and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.