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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA054311 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins. |
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| Treatment as usual | Other | Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | 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. |
| 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, 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) | 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) | 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) | 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 | 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) | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objective Wake After Sleep Onset (Actigraph) | Wake after sleep onset via GENEActiv | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| Change in Objective Sleep Onset Latency (Actigraph) |
| Measure | Description | Time Frame |
|---|---|---|
| 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, and 6 month follow-up |
| Change in Depression (Beck Depression Inventory-II) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina S McCrae, PhD | Contact | 8139741804 | christinamccrae@usf.edu | |
| Britani Holland, PhD | Contact | 8139741804 | blalone@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina S McCrae, PhD | University of South Florida | Principal Investigator |
| Britani Holland, PhD | University of South Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30496533 | Background | McCrae CS, Williams J, Roditi D, Anderson R, Mundt JM, Miller MB, Curtis AF, Waxenberg LB, Staud R, Berry RB, Robinson ME. Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. Sleep. 2019 Mar 1;42(3):zsy234. doi: 10.1093/sleep/zsy234. | |
| 32126156 | Background | McCrae CS, Curtis AF, Miller MB, Nair N, Rathinakumar H, Davenport M, Berry JR, McGovney K, Staud R, Berry R, Robinson M. Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. J Sleep Res. 2020 Dec;29(6):e13020. doi: 10.1111/jsr.13020. Epub 2020 Mar 3. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as usual | Behavioral | 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. |
|
| Tapered Withdrawal | Other | Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist. |
|
| 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, and 6 month follow-up |
| 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, and 6 month follow-up |
| 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, and 6 month follow-up |
| 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, 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) | 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 | 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 | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
Sleep Onset Latency via GENEActiv |
| 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 | 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 | 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 | 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. | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
Depression severity; score range: 0-63 (normal - extreme depression) |
| Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| 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, and 6 month follow-up |
| Medications/Substances Uses and Dosages | Non-opioid pain/sleep medication use and dosage, tobacco, caffeine, alcohol, marijuana via daily electronic diaries | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| Change in Subjective Opioid Withdrawal Scale (SOWS) | Monitor changes in withdrawal symptoms | Single administration at 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| Change in Opioid Cravings Scale | Monitor of cravings related to opioid use | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| Change in NIH Toolbox | 20-minute of two computerized cognitive tasks | Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up |
| 16459140 | Background | Morin CM, LeBlanc M, Daley M, Gregoire JP, Merette C. Epidemiology of insomnia: prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors. Sleep Med. 2006 Mar;7(2):123-30. doi: 10.1016/j.sleep.2005.08.008. Epub 2006 Feb 3. |
| 30176973 | Background | McCrae CS, Mundt JM, Curtis AF, Craggs JG, O'Shea AM, Staud R, Berry RB, Perlstein WM, Robinson ME. Gray Matter Changes Following Cognitive Behavioral Therapy for Patients With Comorbid Fibromyalgia and Insomnia: A Pilot Study. J Clin Sleep Med. 2018 Sep 15;14(9):1595-1603. doi: 10.5664/jcsm.7344. |
| 22396516 | Background | Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234. |
| 23744045 | Background | Martinez MP, Miro E, Sanchez AI, Diaz-Piedra C, Caliz R, Vlaeyen JW, Buela-Casal G. Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. J Behav Med. 2014 Aug;37(4):683-97. doi: 10.1007/s10865-013-9520-y. Epub 2013 Jun 7. |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |