What side effects are associated with this type of intervention?

Common treatments for Sickle Cell Disease (SCD) include hydroxyurea, chronic transfusions, and psychological therapies such as cognitive behavioral therapy (CBT) and family education. Hydroxyurea, the most widely used medication, can cause side effects like bone marrow suppression, gastrointestinal disturbances, and potential teratogenic effects, necessitating discontinuation before conception. Chronic transfusions can lead to iron overload and alloimmunization. Psychological therapies, including ACT, generally have minimal physical side effects but may require significant time and emotional investment from patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Sickle Cell Disease (SCD), including hydroxyurea, which reduces vaso-occlusive pain and other complications, and chronic blood transfusions for selected individuals. Investigational therapies and hematopoietic stem cell transplantation are also explored for their potential benefits. While these treatments primarily address the physiological aspects of SCD, Acceptance and Commitment Therapy (ACT) is being studied for its potential to improve sleep and psychological well-being in SCD patients, focusing on mindfulness and value-based actions.

What other types of research exist?

Promising alternatives to ACT for Sickle Cell Disease patients include: 1) Yoga programs, which have shown feasibility and safety for chronic pain management in SCD. 2) The Stanford Chronic Disease Self-Management Program (CDSMP), which has demonstrated significant improvements in self-efficacy and quality of life for adolescents and young adults with SCD. 3) Progressive Muscle Relaxation Exercises, which have been effective in reducing pain in SCD patients. These interventions offer complementary approaches to managing pain and improving quality of life in SCD patients.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 8, and 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility

Secondary study objectives

Relationship between objective and subjective measures of sleep in SCD.

Relationships among sleep, pain, and quality of life at baseline.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sickle Cell Disease (SCD) include medical therapies like hydroxyurea, which increases fetal hemoglobin to reduce red blood cell sickling and vaso-occlusive episodes, and chronic transfusions, which lower the proportion of sickle cells in the blood. Psychological therapies, such as Acceptance and Commitment Therapy (ACT), focus on enhancing psychological flexibility through mindfulness and value-based actions. This approach is particularly important for SCD patients as it helps them manage chronic pain, stress, and sleep disturbances, significantly improving their quality of life.

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.A qualitative analysis of best self-management practices: sickle cell disease.Psychological therapies for sickle cell disease and pain.