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Completed

NCT Number: NCT04906447

Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

The investigators will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease (SCD), while observing and gathering information on implementation in three health systems: University of Illinois Hospital & Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. During the UH3 Implementation Phase, the 3-arm, 3-site randomized controlled trial will follow a quantitative modified SMART design, a pragmatic trial that evaluates adaptive interventions where the guided relaxation and acupuncture interventions respond to patients' characteristics and evolving pain status. The investigators rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative health (CIH) therapies by those with SCD to reduce pain and opioid use, to help enable them to better cope with their pain, is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will.

Aim 1: Determine the effectiveness of guided relaxation and acupuncture as compared to usual care in decreasing pain and opioid use for SCD patients. Hypothesis: At 6-weeks, SCD patients randomized to either CIH intervention will have a greater decrease in pain, opioid use, sleep, anxiety, depressive symptoms, and pain catastrophizing compared to SCD patients randomized to usual care.

Aim 2: Identify the best adaptive intervention for improved outcomes by documenting outcomes among adaptive intervention sequences: (1) initiate guided relaxation and switch to acupuncture for non-responders at midpoint; (2) initiate guided relaxation and continue with guided relaxation for non-responders at midpoint; (3) initiate acupuncture and switch to guided relaxation for non-responders at midpoint or (4) initiate acupuncture and continue with acupuncture for non-responders at midpoint.

Aim 3: Explore differences in response to the adaptive interventions by age and sex.

Aim 4: Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of CIH therapies into the 3 health systems by conducting individual interviews with participants in the intervention group who responded to the intervention and those who did not. The investigators will also conduct focus groups with hospital personnel at 4 timepoints.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of sickle cell disease based on hemoglobin electrophoresis
  • Provision of signed and dated informed consent form
  • Able to speak and understand English
  • Chronic pain, defined as a response of "Some days," "Most days" or "Every day" to the question, "In the past 3 months, how often have you had pain?" (Answer options: Never, Some days, Most days, Every day)
  • Current pain interference using the general activity question from PEG, score ≥3 on 0-10 scale

Exclusion criteria

  • Has had a stem cell transplant for sickle cell disease
  • Current incarceration
  • Any other condition that the investigator considers precludes participation in the clinical trial

Treatment and study plan

Guided Relaxation

Behavioral

Guided relaxation uses the mind to reduce pain, promote well-being, and improve physical function. Guided relaxation is a state of concentration and focused attention that gives people more control over their pain experience and its impact and an increased sense of well-being.

Acupuncture

Other

Acupuncture is a body-based therapy that includes the insertion of thin needles at strategic points on the body that has been proven effective for reducing pain.

Primary outcomes

  1. PROMIS Pain Interference

    Time frame: From Baseline to 24 weeks

    Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more

  2. Pain, Enjoyment of Life and General Activity scale (PEG)

    Time frame: From Baseline to 24 weeks

    0-10 rating on pain intensity, enjoyment of life and general activity

  3. PROMIS Physical Function

    Time frame: From Baseline to 24 weeks

    4-20 rating on the impact of pain on ability to perform normal activities; higher scores indicate greater impact of pain on physical function

Secondary outcomes

  1. Generalised Anxiety Disorder Questionnaire (GAD-7)

    Time frame: From Baseline to 24 weeks

    Measure of Anxiety with scores ranging from 0-21. Higher scores indicate higher levels of anxiety.

  2. Patient Health Questionnaire Depression Scale (PHQ)

    Time frame: From Baseline to 24 weeks

    0-24 rating of depression. 10 or greater total is considered major depression, 20 or more is severe major depression.

  3. PROMIS sleep disturbance 8a

    Time frame: From Baseline to 24 weeks

    8-40 rating with higher scores indicating greater severity of sleep disturbance

  4. Sleep duration

    Time frame: From Baseline to 24 weeks

    Hours a participant has slept

  5. Pain Catastrophizing Scale (PCS)

    Time frame: From Baseline to 24 weeks

    0-52 scale with higher scores indicating more catastrophizing thoughts are present

  6. Patient's Global Impression of Change (PGIC)

    Time frame: From Baseline to 24 weeks

    1-7 scale with higher scores indicating more improvement in pain from the patient's perspective

  7. Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1)

    Time frame: From Baseline to 24 weeks

    1-20 scale with higher score relating to more frequent substance use over the past 12 months

  8. Gastrointestinal Constipation 9a

    Time frame: From Baseline to 24 weeks

    9-45 scale with higher scores indicating more severe constipation symptoms

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Duke University
  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Florida

Registry information

Acronym: GRACE

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 28, 2021
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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