The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.
Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory (CATS) and empirical findings. It also reflects federal pain research priorities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
165
Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.
Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.
University of South Florida
Tampa, Florida, United States
RECRUITINGChange in Insomnia Severity Index
Insomnia severity; score range 0-28 (low severity - high severity)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Pain Intensity - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Daily electronic dairies will record wake after sleep onset (number of minutes)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep onset latency (number of minutes)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep efficiency
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Fatigue - Daily Electronic Sleep Diaries
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
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Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Daily electronic dairies will record daily medication consumption)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Perceived Stress Scale
Perception of stress; score range: 0-40 (low stress - high stress)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Peripheral Arousal
Heart Rate Variability (as measured by Holter-Monitoring)
Time frame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
Assessment of neural plasticity
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
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)
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Opioid Use (Quantitative)
Change in opioid use assessed with quantitative urine opioid panel
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Opioid Use (Self-Report)
Change in opioid use assessed with daily electronic diaries
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Wake After Sleep Onset (Actigraph)
Wake after sleep onset via GENEActiv
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Sleep Onset Latency (Actigraph)
Sleep Onset Latency via GENEActiv
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Objective Sleep Efficiency (Actigraph)
Sleep Efficiency via GENEActiv
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging
Assessment of brain connectivity
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
Short Inventory of Problems
Modified from validated alcohol survey for opioid related problems
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up
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.
Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up