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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Guided Relaxation
* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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 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 A known diagnosis of moderate or severe opioid use disorder by Diagnostic and Statistical Manual of Mental Disorders-5 criteria Current incarceration Patients who are on a chronic transfusion/exchange program Any other condition that the investigator considers precludes participation in the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>Participants randomized to the control arm will receive usual care | |
| Experimental: Acupuncture<br>Acupuncture treatments twice a week for five weeks | Other: Acupuncture<br>* 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.<br>|
| Experimental: Guided Relaxation<br>Daily use of a guided relaxation app for 6 weeks | Behavioral: Guided Relaxation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain Interference | Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more | From Baseline to 24 weeks | 
| Pain, Enjoyment of Life and General Activity scale (PEG) | 0-10 rating on pain intensity, enjoyment of life and general activity | From Baseline to 24 weeks | 
| PROMIS Physical Function | 4-20 rating on the impact of pain on ability to perform normal activities; higher scores indicate greater impact of pain on physical function | From Baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalised Anxiety Disorder Questionnaire (GAD-7) | Measure of Anxiety with scores ranging from 0-21. Higher scores indicate higher levels of anxiety. | From Baseline to 24 weeks | 
| Patient Health Questionnaire Depression Scale (PHQ) | 0-24 rating of depression. 10 or greater total is considered major depression, 20 or more is severe major depression. | From Baseline to 24 weeks | 
| PROMIS sleep disturbance 8a | 8-40 rating with higher scores indicating greater severity of sleep disturbance | From Baseline to 24 weeks | 
| Sleep duration | Hours a participant has slept | From Baseline to 24 weeks | 
| Pain Catastrophizing Scale (PCS) | 0-52 scale with higher scores indicating more catastrophizing thoughts are present | From Baseline to 24 weeks | 
| Patient's Global Impression of Change (PGIC) | 1-7 scale with higher scores indicating more improvement in pain from the patient's perspective | From Baseline to 24 weeks | 
| Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1) | 1-20 scale with higher score relating to more frequent substance use over the past 12 months | From Baseline to 24 weeks | 
| Gastrointestinal Constipation 9a | 9-45 scale with higher scores indicating more severe constipation symptoms | From Baseline to 24 weeks |