Status:
TERMINATED
TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Indiana Clinical and Translational Sciences Institute
Conditions:
Insomnia
Chronic Pain
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact em...
Eligibility Criteria
Inclusion
- Youth
- Aged 12 to 17 years.
- Meets criteria for insomnia with or without comorbid chronic musculoskeletal pain.
- Parent/guardian available to provide consent.
- Patient and a primary caregiver are able to independently read and understand English well enough to provide informed consent and complete study procedures.
- Access to email, internet, and audio and video call capabilities.
- Parent/Guardian
- Parent/legal guardian of a child meeting above eligibility criteria
- Able to independently read and understand English well enough to provide informed consent and complete study questionnaires.
- Youth
Exclusion
- History of cardiac or neuromuscular disorder
- Parent-report of child's use of Opioid medications (i.e., fentanyl, morphine, hydromorphone, methadone, hydrocodone, oxycodone) that cannot be discontinued for 7 days prior to study visits.
- Inadequate proficiency in English or a developmental disability that interferes with informed consent/assent or completion of study procedures.
- History of obstructive sleep apnea, restless leg syndrome, or narcolepsy.
- History of bipolar disorder and/or manic episodes
- Diagnosis of epilepsy.
- Currently in foster care or considered a ward of the state.
- History of Raynaud Syndrome.
- Active suicidal ideation, intent or plan in the past month.
- Parent
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04920630
Start Date
May 10 2021
End Date
May 5 2023
Last Update
August 23 2023
Active Locations (1)
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1
Riley Hospital for Childre
Indianapolis, Indiana, United States, 46202