TRAIN Your Sleep: Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Indiana University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change from baseline Conditioned Pain Modulation (CPM)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. In this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation.
Study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (CBT-I) intervention, and a follow-up assessment. Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. Assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (QST). Participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. QST will assess pain inhibition via conditioned pain modulation (CPM) and pain facilitation via temporal summation (TS).
Investigators
Amy E. Williams
Associate Professor of Clinical Psychiatry
Indiana University
Eligibility Criteria
Inclusion Criteria
- •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 Inclusion Criteria:
- •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.
Exclusion Criteria
- •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 Exclusion Criteria:
Outcomes
Primary Outcomes
Change from baseline Conditioned Pain Modulation (CPM)
Time Frame: 1-4 weeks post-treatment
Heat pain threshold (test stimulus) will be assessed on the volar surface of the dominant forearm twice before before, during, and after immersion (for 1 minute) of the non-dominant hand in a circulated cold-water bath (conditioning stimulus) maintained at 5˚C ±1˚C. Heat pain threshold will be assessed via the method of limits. Subjects will be instructed to push a button as soon as the heat feels painful, which will stop the trial. Immediately before and after the CPM assessment, the subjects' non-dominant hand will be placed in a room-temperature water bath (20-25˚C) for 2 minutes. The CPM effect will be calculated as a difference score: heat pain threshold during conditioning stimulus minus baseline. A negative score indicates pain inhibition.
Change from baseline Temporal Summation of Pain (TS)
Time Frame: 1-4 weeks post-treatment
Temporal summation will be assessed via a series of 10 brief (\~0.5s duration for peak, total time for heating, peak, and cooling \<1.5s) heat pulses (48˚C) delivered via a Medoc Thermal Sensory Analyzer-2 thermode positioned on the volar surface of the forearm. Time between each peak will be 3 seconds. Subjects will provide a verbal pain rating immediately after the first and last heat pulse is delivered. Pain ratings will be made on a 0-100 numerical rating scale (0=no pain, 100=most pain imaginable), which will be displayed during the assessment. Temporal summation will be calculated as a difference score (i.e., pain during final stimulus minus pain during initial stimulus), with a positive score indicating pain facilitation due to temporal summation.
Secondary Outcomes
- Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).(1-4 weeks post-treatment)
- Change from baseline score on Pediatric Insomnia Severity Index (PISI)(1-4 weeks post-treatment)
- Change from baseline score on Generalized Anxiety Disorder -7(1-4 weeks post-treatment)
- Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)(1-4 weeks post-treatment)