ACT for Sleep Disturbances in Sickle Cell Disease

Overseen By Staci M Peron, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Uncontrolled psychiatric illness, cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Acceptance and Commitment Therapy (ACT) can assist individuals with sickle cell disease (SCD) who experience sleep problems. ACT includes mindfulness exercises and teaches new ways to manage thoughts about sleep. The trial aims to determine if ACT improves sleep and to understand participants' experiences with it. Individuals with SCD who have experienced sleep difficulties for at least three months and possess the necessary technology for remote participation may be suitable candidates. Participants will engage in weekly video sessions and wear a device to monitor their sleep patterns. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance sleep for those with SCD.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. However, you should not plan to start new treatments or change medications that affect sleep during the study.

What prior data suggests that Acceptance and Commitment Therapy is safe for people with sleep disturbances in sickle cell disease?

Research has shown that Acceptance and Commitment Therapy (ACT) might assist people with sickle cell disease (SCD) who experience sleep difficulties. While ACT hasn't been specifically studied for sleep issues in SCD, it is generally well-received by other groups.

ACT has improved quality of life and daily functioning in both adults and children with SCD. Promising evidence suggests it can enhance well-being and help manage the condition. Since ACT involves guided mindfulness and mental exercises, it avoids the side effects associated with medications.

Overall, ACT appears to be a safe option with no known serious side effects reported in similar cases. Participants can expect a supportive experience that focuses on managing thoughts and feelings related to sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for sleep disturbances in individuals with sickle cell disease because it offers a novel approach that differs from traditional treatments like medication or cognitive behavioral therapy. Most treatments focus on directly changing negative thoughts or using medication to manage sleep issues. ACT, however, emphasizes accepting thoughts without letting them dictate behavior, staying present, and aligning actions with personal values. This method can empower individuals to manage sleep disturbances in a more holistic way, potentially leading to longer-lasting benefits without the side effects often associated with medication.

What evidence suggests that ACT might be an effective treatment for sleep disturbances in sickle cell disease?

This trial will compare the effectiveness of Acceptance and Commitment Therapy (ACT) with a waitlist control group for sleep disturbances in individuals with sickle cell disease. Studies have shown that ACT can improve sleep in people with long-term illnesses. Specifically, for those with sickle cell disease, ACT boosts daily functioning and quality of life by reducing stress and encouraging better habits. Research indicates that sleep improvements often begin within the first three weeks of ACT treatment. By focusing on mindfulness and altering thought patterns, ACT helps individuals develop healthier sleep habits. This therapy shows promise for those dealing with sleep problems related to chronic conditions. ^{2 6 7 8 9}

Who Is on the Research Team?

Staci M Peron, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I either have a high score for sleep problems or am unhappy with my sleep.

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.

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

Individuals currently enrolled in a treatment protocol that would impact sleep

My cancer is progressing but not to the point where I can't participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Remote screening

Baseline

1-week baseline actigraphy data collection period

1 week

Remote data collection

Treatment

8-week ACT intervention with weekly video chat sessions and actigraphy monitoring

8 weeks

8 remote sessions

Follow-up

Participants complete a survey 4 weeks after ACT treatment to assess the intervention's helpfulness and ease of use

4 weeks

Remote survey

What Are the Treatments Tested in This Trial?

Interventions

• ACT Intervention
• Waitlist

Trial Overview 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.

How Is the Trial Designed?

Group I: 1/Immediate Intervention Group Active Control 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 37 adults with chronic insomnia, both Acceptance and Commitment Therapy for Insomnia (ACT-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduced insomnia severity, but CBT-I had a higher proportion of treatment responders immediately after treatment (64.7% vs. 50.0%).

Six months later, ACT-I showed continued improvement in insomnia severity, while the effectiveness of CBT-I slightly decreased, suggesting that ACT-I may offer longer-term benefits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial (RCT) of Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Chronic Insomnia. El Rafihi-Ferreira, R., Morin, CM., Hasan, R., et al.[2023]

In a study of 62 adults with sickle cell disease (average age 32), about 17% reported clinically significant sleep disturbances, which were not directly linked to their executive functioning abilities.

Anxiety was found to mediate the relationship between sleep difficulties and executive functioning, suggesting that addressing anxiety may help improve cognitive outcomes for adults with sickle cell disease experiencing sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbance in adults with sickle cell disease: relationships with executive and psychological functioning. Rhodes, A., Martin, S., Wolters, P., et al.[2021]

Cognitive and psychological difficulties, such as issues with executive function and increased anxiety or depression, are significant complications for pediatric patients with sickle cell disease (SCD) and should be considered as important endpoints in clinical trials.

The review identifies specific, reliable cognitive tests and patient-reported outcomes (like the NIH Toolbox Cognition Module and PROMIS scales) that can effectively measure the impact of SCD on patients' daily lives, emphasizing the need for patient-centered approaches in treatment evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for Selecting Cognitive Endpoints and Psychological Patient-Reported Outcomes for Clinical Trials in Pediatric Patients With Sickle Cell Disease. Hood, AM., Crosby, LE., Stotesbury, H., et al.[2023]

Acceptance and Commitment Therapy (ACT) was found to significantly improve sleep quality and reduce anxiety in patients with chronic primary insomnia, showing particular effectiveness in those with high anxiety about sleep problems.

In a study of 30 patients over four weeks, both ACT and Cognitive Behavior Therapy for Insomnia (CBT-I) improved insomnia symptoms, but only ACT led to a significant reduction in anxiety, suggesting it may be a valuable alternative for patients who do not respond to CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Acceptance and Commitment Therapy (ACT) and Cognitive Behavior Therapy (CBT) for Chronic Insomnia: A Pilot Randomized Controlled Trial. Shin, JW., Kim, S., Shin, YJ., et al.[2023]

In a study of 70 African-American adults with sickle cell disease, negative thinking and passive coping strategies were linked to increased pain frequency, duration, and severity, as well as reduced activity levels and more hospitalizations.

The research highlighted that while negative affectivity influenced these relationships, some connections between coping strategies and health outcomes remained significant, suggesting that addressing negative thinking and coping styles could improve health in individuals with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health status in sickle cell disease: examining the roles of pain coping strategies, somatic awareness, and negative affectivity. McCrae, JD., Lumley, MA.[2022]

A study involving a 16-year-old with sickle cell disease and his parents showed that an eight-session Acceptance and Commitment Therapy (ACT) program led to significant improvements in the adolescent's functioning and quality of life, particularly noted at a 3-month follow-up.

The positive outcomes were linked to increased psychological flexibility in the adolescent and greater acceptance from the parents, suggesting that ACT may be an effective therapeutic approach for enhancing the well-being of adolescents with chronic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case study: Acceptance and commitment therapy for pediatric sickle cell disease. Masuda, A., Cohen, LL., Wicksell, RK., et al.[2011]

In a study of 72 adult patients with sickle cell disease, 47% reported experiencing insomnia and 15% reported sleep impairment, highlighting a significant prevalence of sleep issues in this population.

The research found strong links between pain and sleep impairment, suggesting that managing pain could help improve sleep quality, while common medications like anxiolytics and long-acting opioids did not show a direct association with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep impairment and insomnia in sickle cell disease: a retrospective chart review of clinical and psychological indicators. Mann-Jiles, V., Thompson, K., Lester, J.[2016]

A study involving 45 adults with chronic insomnia found that both Acceptance and Commitment Therapy-based Behavioral Intervention for Insomnia (ACT-BBI-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep patterns and reduced insomnia symptoms, with benefits maintained for six months after treatment.

ACT-BBI-I focuses on acceptance and commitment processes, while CBT-I emphasizes cognitive restructuring; both approaches showed effectiveness, suggesting that integrating ACT principles with behavioral techniques could be beneficial for insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy-based behavioral intervention for insomnia: a pilot randomized controlled trial. El Rafihi-Ferreira, R., Morin, CM., Toscanini, AC., et al.[2021]

In a study of 50 adolescents with sickle cell anemia, sleep quality was found to be poor, characterized by reduced total sleep time and REM sleep, along with increased awakenings and sleep-disordered breathing.

The study suggests that sleep issues in these patients are likely linked to hemoglobin desaturation during sleep rather than problems with lung function, as spirometric values remained normal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of sleep and pulmonary function in clinically stable adolescents with sickle cell anemia. Souza, LC., Viegas, CA.[2022]

A study involving 12 adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) found that all participants considered Acceptance and Commitment Therapy (ACT) to be an acceptable treatment option, suggesting it may be a viable alternative for those who remain symptomatic after standard treatments.

Most adolescents expressed willingness to participate in a randomized controlled trial (RCT) of ACT, although concerns about randomization and the timing of the intervention need to be addressed to facilitate recruitment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative study of the acceptability and feasibility of acceptance and commitment therapy for adolescents with chronic fatigue syndrome. Clery, P., Starbuck, J., Laffan, A., et al.[2022]

In a study of 109 African-American adults with sickle cell disease, good psychological adjustment was linked to lower perceived daily stress and better family support, highlighting the importance of social factors in managing chronic illness.

The model used in the study explained 44-50% of the variance in psychological adjustment, indicating that effective coping strategies and family dynamics play a crucial role in how individuals adapt to living with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress, coping, and psychological adjustment of adults with sickle cell disease. Thompson, RJ., Gil, KM., Abrams, MR., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05457790/feasibility-and-preliminary-efficacy-of-acceptance-and-commitment-therapy-act-for-sleep-disturbances-in-adults-with-sickle-cell-disease-scd

Feasibility and Preliminary Efficacy of Acceptance and ... Also, they often have trouble sleeping. Acceptance and commitment therapy (ACT) might help people with SCD to improve their sleep problems.

2. withpower.com withpower.com/trial/phase-nonorganic-insomnia-6-2022-62e4b?lat=34.60184&lng=-117.81218

ACT for Sleep Disturbances in Sickle Cell Disease A case study showed that Acceptance and Commitment Therapy (ACT) helped improve functioning and quality of life for an adolescent with sickle cell disease, ...

3. clinicaltrial.be clinicaltrial.be/nl/details/16064?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Feasibility and Preliminary Efficacy of Acceptance and Co... Acceptance and Commitment Therapy (ACT) has been found effective in improving several aspects of health and wellbeing in individuals with chronic illness and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7916154/

Acceptance and Commitment Therapy (ACT) Improves ... Micro-analyses showed that improvements occurred within the first three weeks of treatment. The pattern of results suggests that ACT appeared to have improved ...

5. contextualscience.org contextualscience.org/acbs_research_development_grant_scheme_20212022_awardees

ACBS Research Development Grant Scheme - 2021-2022 ... Acceptance and Commitment Therapy (ACT) is an emerging evidence-based approach for sleep problems. Preliminary research shows ACT to be effective as measured by ...

6. ctv.veeva.com ctv.veeva.com/study/feasibility-and-preliminary-efficacy-of-acceptance-and-commitment-therapy-act-for-sleep-disturbanc

Feasibility and Preliminary Efficacy of Acceptance and ... To our knowledge, ACT for sleep disturbance has not been investigated yet among individuals with SCD.

7. ashpublications.org ashpublications.org/bloodadvances/article/4/12/2656/460974/American-Society-of-Hematology-2020-guidelines-for

American Society of Hematology 2020 guidelines for sickle ... For adults and children with SCD who have chronic pain related to SCD, the ASH guideline panel suggests cognitive and behavioral pain management ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21325269/

Acceptance and commitment therapy for pediatric sickle ... This study describes ACT for improving functioning and quality of life for an adolescent with SCD and his parents.

9. academic.oup.com academic.oup.com/jpepsy/article/36/4/398/927698

Acceptance and Commitment Therapy for Pediatric Sickle Cell ... The study provides preliminary but promising data that ACT is a viable approach for improving functioning and QOL for adolescents with SCD and ...