ACT for Sleep Disturbances in Sickle Cell Disease

Overseen by Staci M Peron, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Uncontrolled psychiatric illness, cognitive impairments, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if Acceptance and Commitment Therapy (ACT) can help adults with sickle cell disease (SCD) who have trouble sleeping. Participants will have regular video sessions with a coach, focusing on mindfulness and personal values. They will also wear a wrist device to track their sleep and complete surveys about their health. ACT has been effective in promoting quality of life and functioning in adolescents with chronic illness.

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 data supports the effectiveness of the treatment Acceptance and Commitment Therapy (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, suggesting it may help with related issues like sleep disturbances. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) is generally considered safe for humans, as it focuses on psychological techniques to help people accept their thoughts and feelings. There is no specific safety data for ACT in sickle cell disease, but it has been used safely in various conditions to improve mental health and quality of life. ^{1 2 5 6 7}

How is the ACT treatment for sleep disturbances in sickle cell disease different from other treatments?

ACT (Acceptance and Commitment Therapy) is unique because it focuses on helping patients accept difficult feelings and thoughts, and encourages them to live according to their values, rather than trying to eliminate symptoms. This approach is different from traditional therapies that often aim to directly change or reduce symptoms. ^{1 8 9 10 11}

Research Team

Staci M Peron, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• ACT Intervention (Behavioural Intervention)
• Waitlist (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A case study: Acceptance and commitment therapy for pediatric sickle cell disease. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep impairment and insomnia in sickle cell disease: a retrospective chart review of clinical and psychological indicators. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Stress, coping, and psychological adjustment of adults with sickle cell disease. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Quality of sleep and pulmonary function in clinically stable adolescents with sickle cell anemia. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Sleep disturbance in adults with sickle cell disease: relationships with executive and psychological functioning. [2021]

7. Switzerland 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. [2023]

8. New Zealand 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. [2023]

9. Brazil pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy-based behavioral intervention for insomnia: a pilot randomized controlled trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Qualitative study of the acceptability and feasibility of acceptance and commitment therapy for adolescents with chronic fatigue syndrome. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial (RCT) of Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Chronic Insomnia. [2023]