Clinical trial NCT04920630: TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
Official title: TRAIN Your Sleep: Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Chronic Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana Clinical and Translational Sciences Institute
First posted: 2021-06-10
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: Youth 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.

Youth 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:

• Inadequate proficiency in English or a developmental disability that interferes with informed consent or completion of questionnaires.

Primary outcomes:
measure: Change from baseline Conditioned Pain Modulation (CPM)
timeFrame: 1-4 weeks post-treatment
measure: Change from baseline Temporal Summation of Pain (TS)
timeFrame: 1-4 weeks post-treatment
Secondary outcomes:
measure: Change from baseline score on Generalized Anxiety Disorder -7
timeFrame: 1-4 weeks post-treatment
measure: Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).
timeFrame: 1-4 weeks post-treatment
measure: Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)
timeFrame: 1-4 weeks post-treatment
measure: Change from baseline score on Pediatric Insomnia Severity Index (PISI)
timeFrame: 1-4 weeks post-treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Childre
state: Indiana
Study officials:
References: