NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients

Study Overview
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Brief Summary
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This project addresses the highly significant problem of developing effective strategies for facilitating withdrawal from opioid medications. The proposed work is conceptualized within the context of a well-known theoretical framework (Cognitive Activation Theory of Stress), and the research questions are theory-driven. The team proposes to evaluate an innovative web-based version of CBT-I followed by tapered withdrawal in a randomized trial in comparison to a Treatment As Usual control followed by tapered withdrawal. The dependent measures have been well-selected to effectively evaluate the outcomes. The methodological details are rigorous.

Detailed Description
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Individuals with chronic widespread pain are often prescribed opioid therapy. Unfortunately, opioid therapy offers questionable benefit for long-term pain management and is associated with other negative outcomes (arrhythmias, overdose, death). Individuals with chronic pain experience high rates of comorbid chronic insomnia, increased cognitive and physiological arousal, and disrupted executive function. They also often develop abnormal brain activation at rest and in response to painful stimuli (aka central sensitization). The investigator's research and other research shows individuals with chronic pain exhibit increased brain activation in the default mode network at rest and in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids can be difficult; and inadequately managed pain, abnormal brain activation, disrupted executive function, increased arousal, and poor sleep contribute to that difficulty. Consistent with the Cognitive Activation Theory of Stress (CATS), The investigators hypothesize that poor sleep and sustained arousal lead to critical changes in brain activation and disrupted executive function that increase pain and lead to opioid use. The proposed pilot will randomize 26 prescription opioid users who have chronic widespread pain and insomnia to 4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou) or treatment as usual. They will then complete a gradual tapered withdrawal protocol for opioids.

Official Title
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Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing

Conditions
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Chronic Pain, Chronic Insomnia, Opioid Use

Intervention / Treatment
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* Behavioral: NiteCAPP HELPS
* Other: Tapered Withdrawal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ yrs old willing to be randomized can read/understand English diagnosed with chronic widespread pain and insomnia prescribed opioid medication for 1+ mo, 3+ times per week desire to reduce or eliminate opioid use written agreement from physician prescribing opioid medication no prescribed or OTC sleep meds for 1+ mo, or stabilized for 6+ wks. Exclusion Criteria: unable to provide informed consent cognitive impairment (MMSE <26) sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15), Periodic Limb Movement Disorder (myoclonus arousals per hour >15)] bipolar or seizure disorder (due to risk of sleep restriction treatment) other severe, untreated major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders) psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed) participation in other non-pharmacological treatment for pain, sleep, or mood outside current Internal metal objects or electrical devices pregnancy presumptive/confirmed lumbar nerve root compression confirmed lumbar spinal stenosis <6 mos post back surgery other spinal disorders

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NiteCAPP HELPS<br>4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins. | Behavioral: NiteCAPP HELPS<br>* 4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou)<br>Other: Tapered Withdrawal<br>* Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.<br>|
| Other: Treatment as Usual<br>Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins. | Other: Tapered Withdrawal<br>* Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | Insomnia severity; score range 0-28 (low severity - high severity) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Pain Intensity - Daily Electronic Sleep Diaries | Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries | Daily electronic dairies will record wake after sleep onset (number of minutes) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Sleep Onset Latency- Daily Electronic Sleep Diaries | Daily electronic dairies will record sleep onset latency (number of minutes) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Sleep Efficiency- Daily Electronic Sleep Diaries | Daily electronic dairies will record sleep efficiency | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Fatigue - Daily Electronic Sleep Diaries | Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries | Daily electronic dairies will record daily medication consumption | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Perceived Stress Scale | Perception of stress; score range: 0-40 (low stress - high stress) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Peripheral Arousal | Heart Rate Variability (as measured by Holter-Monitoring) | 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Pain Catastrophizing Scale | The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score range from 0-52, with higher scores indicating greater pain catastrophizing. | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging | assessment of neural plasticity | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Thermal Pain Response | Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Opioid Use (Quantitative) | Change in opioid use assessed with quantitative urine opioid panel | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Opioid Use (Self-Report) | Change in opioid use assessed with daily electronic diaries | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in State-Trait Anxiety Inventory (STAI) | Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Depression (Beck Depression Inventory-II) | Depression severity; score range: 0-63 (normal - extreme depression) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in 36-Item Short Form Survey (SF-36) | Self-reported health; score range: low quality of life to high quality of life | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Objective Wake After Sleep Onset (Actigraph) | Wake after sleep onset via Actiwatch-2 | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Objective Sleep Onset Latency (Actigraph) | Sleep Onset Latency via Actiwatch-2 | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in Objective Sleep Efficiently (Actigraph) | Sleep Efficiency via Actiwatch-2 | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in NIH Toolbox | 20 minute computerized cognitive tasks | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 
| Change in non-opioid substance use | self reported changes in non-opioid substances via electronic diaries | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tapered withdrawal, NiteCAPP