Sleep and Pain Interventions in Women with Fibromyalgia (SPIN-II)

Clinicaltrials.gov (Identifier): NCT03744156   
Funded by the National Institute of Nursing Research (1R01NR017168-01A1; Christina S. McCrae, PI)

Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

We are currently recruiting women with fibromyalgia and insomnia. Participants will undergo eight treatment sessions with a sleep therapist who will work with them on an individual basis. All study visits will take place at the Mizzou Sleep Research Lab. Parking will be provided.  This project is a collaboration between the Mizzou Sleep Research Lab and the Brainstorm Lab (within the Department of Physical Therapy at the University of Missouri).

Contact for more information:
spin@missouri.edu
573-884-7487

Better Rest for Children with Autism (RECHArge)

Clinicaltrials.gov (Identifier: NCT02755051)
Funded by the University of Missouri Research Board (Christina S. McCrae, PhD, and Micah Mazurek, PhD, Co-PIs)

RECHArge is a clinical trial of a novel family-based behavioral sleep intervention that has been specifically designed to target behavioral sleep problems in children with Autism Spectrum Disorders (ASD). The overall objective of this study is to test this newly developed sleep intervention in 30 children with ASD. Children and their parent(s) will undergo eight treatment sessions and will be assigned a sleep therapist who will work with each family on an individual basis. All study visits take place at the Thompson Center for Autism and Neurodevelopment Disorders. This project is a collaboration between the MizZzou Sleep Research Lab and the Thompson Center.

For more information:
recharge@missouri.edu
573-884-7428

Sleep and Pain Interventions for Chronic Widespread Pain (SPIN-CWP)

Clinicaltrials.gov (Identifier: NCT02755051)
Funded by the University of Missouri (Christina S. McCrae, PI)

SPIN-CWP is a randomized controlled clinical trial that will examine the effects of CBT­ in patients with chronic widespread pain. The proposed study design will yield important information about the mechanisms involved in the maintenance of chronic pain symptoms. The purpose of this study is to examine the relationship between chronic pain and chronic sleep disturbance in patients with chronic pain so that clinicians can more effectively treat core causes to symptoms. This is important to examine because of the potential etiological role of sleep disruption in the chronicity of chronic pain conditions. This project is a collaboration between the MizZzou Sleep Research Lab and the Brainstorm Lab (within the Department of Physical Therapy at the University of Missouri).

For more information:
SPIN@missouri.edu
573-884-7428

Pediatric Obesity and Pediatric Sleep (POPS)

Clinicaltrials.gov (Identifier: NCT02232217)
Funded by the National Heart, Lung, and Blood Institute (R21HL121432; Christina S. McCrae & David Janicke, co-PIs)

POPS is a randomized clinical trial of a novel family-based behavioral sleep intervention that has been specifically designed to target behavioral sleep problems in overweight and obese children. This study is currently running at the University of Florida, where children and their parent(s) will be randomly assigned to one of two behavioral sleep treatments. In both treatments, children will undergo eight treatment sessions with a sleep therapist who will work with each family on an individual basis.

Please note that this study is currently recruiting at the University of Florida. All study visits take place at the University of Florida in Gainesville. This project is a collaborative effort between Dr. McCrae (University of Missouri) and Dr. Janicke (University of Florida). We are not recruiting for this study in Columbia, Mo. However, we are planning a related trial (see Studies in the Works).

If your child is overweight or obese and has sleep problems AND you live in or near Gainesville, Fla., please contact:

David M Janicke, PhD
University of Florida
352-273-6046
djanicke@phhp.ufl.edu

Better Rest for Children with Autism – Remote (RECHArge-Remote)

Clinicaltrials.gov (Identifier: TBD)
Funded by the University of Missouri Research Board (Christina S. McCrae, PhD, and Micah Mazurek, PhD, Co-PIs)

RECHArge-Remote will be a new clinical trial that is a spin-off of RECHArge. This spin-off trial involves a shortened treatment protocol (four sessions as opposed to the eight sessions in our current RECHArge trial). Similar to the current trial, RECHArge-remote will involve a clinical trial of a novel family-based behavioral sleep intervention that has been specifically designed to target behavioral sleep problems in children with Autism Spectrum Disorders (ASD). The overall objective of spin-off study is to test a briefer, remotely delivered sleep intervention in 15 children with ASD. Children and their parent(s) will undergo four remotely delivered (videoconferencing) treatment sessions. A trained sleep therapist will work with each family on an individual basis. This project is a collaboration between the MizZzou Sleep Research Lab and the Thompson Center for Autism.

For more information:
recharge@missouri.edu
573-884-7428

Future Studies

Insomnia and Obesity

We are interested in examining the effects of CBT-insomnia in populations who have problems with obesity. We are going to launch a clinical trial testing the effectiveness of CBT-I for obese adults. More to come!

Completed Research

Sleep and Pain Interventions in Fibromyalgia (SPIN)

Clinicaltrials.gov (Identifier: NCT02001077)

Funded by the National Institutes of Arthritis and Musculoskeletal and Skin Diseases (R01AR055160; R01AR055160-S1; Christina S. McCrae, PI)

Sleep disturbances are common among chronic pain patients, with reports typically ranging from 50-70 percent of patients reporting sleep difficulties. This randomized controlled clinical trial examined the effects of non-drug Cognitive-Behavioral Treatments for insomnia CBT-I) and for pain (CBT-P) in fibromyalgia patients. We enrolled 113 adults with fibromyalgia and chronic insomnia. Participants were randomly assigned to CBT-I, CBT-P, or waitlist control. Each of the treatments involved 8 weekly sessions. Those randomized to the wait-list were offered a combined (both CBT-I and CBT-P) treatment at the end of the study.

Both Cognitive-Behavioral Treatment for Insomnia (CBT-I) and Cognitive-Behavioral Treatment for Pain (CBT-P) are evidence-based treatments. That means research has shown that they can help people improve their sleep and pain. The mission of the SPIN study was to understand the scientific basis of how these therapies work on pain and sleep problems.

Data collection for this study has completed. See below for published and presented items from this project. Data dissemination from this project is on-going with additional manuscripts either in submission or in preparation for submission.

Research Evaluating Sleep and Thinking in Older Adults with Insomnia (REST)

Funded by the National Institute on Aging (AG024459-01; Christina S. McCrae, PhD, PI)

Insomnia affects up to 35 percent of individuals aged 65 and older. Although older adults with insomnia (OAWI) frequently complain of impaired cognitive functioning, objective evidence of such impairment has been sparse. Correlational studies have found evidence of deficits in cognitive performance in OAWI. Unfortunately, because the typical correlational design utilizes ‘one shot’ assessments, such studies provide only a ‘snapshot’ of the sleep/cognition relationship. This approach could be improved as both sleep and cognitive performance may exhibit considerable day-to-day variability, particularly in older adults. Using repeated daily assessments, these fluctuations in sleep and cognition (intraindividual variability or IIV) can be captured and modeled. SPIN participants completed daily sleep dairies and brief daily cognitive diaries throughout the course of a brief (four-session) behavioral treatment program for insomnia. We believe studying OAWI intensively over the course of treatment will provide insights into the day-to-day fluctuations in sleep and cognition within individuals (i.e., IIV) and will permit a detailed examination of the extent to which IIV in cognitive performance is related to fluctuations in sleep.

Active Adult Mentoring Program (AAMP)

Funded by the University of Florida Aging Network Research Enhancement Fund (Christina S. McCrae, PhD, PI*)

*Note funding was obtained on behalf of the entire AAMP team. Peter Giacobbi, PhD, Michael Marsiske, PhD., Beverly Roberts, PhD, Matthew Buman, M., Adrienne Aiken Morgan, MS, and Joseph Dzierzewski, MS, and all collaborators participated equally in the development of the funding application.

This trial tested a 16-week multi-component exercise promotion intervention for older adults.

Research Evaluation Brief Behavioral Sleep Treatments for Rural Elderly (RESTore)

Funded by the Substance Abuse and Mental Health Services Administration and the Office of Rural Health Policy/Missouri (DO4RHOO242; Rene McGovern, PhD, Program Director; Christina S. McCrae, PhD, Study PI)

This study examined the effectiveness of a four-week brief behavioral intervention for insomnia in older adults with insomnia living in an 11-county area of northeast Missouri.  This study was a collaborative effort with ElderLynk, a federal/state sponsored Health Professional Shortage Area (HPSA) program, providing mental health services to the elderly in northeast Missouri.