TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)

TRAIN Your Sleep: Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy - Insomnia (CBT-I)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Childre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CBT-I; 5-weekly Cognitive Behavioral Therapy for Insomnia group therapy sessions conducted virtually.

Behavioral: Cognitive Behavioral Therapy - Insomnia (CBT-I); CBT-I will be delivered via 5 weekly virtual group therapy sessions. Session content is manualized and adapted from existing CBT-I protocols to be relevant to a virtual adolescent group and will include: Session 1 - Introduction of group members, group rules, psychoeducation regarding sleep, and instructions on completion of sleep log. Session 2 - Review sleep log, sleep hygiene, relaxation training, and stimulus control. Session 3 - Review sleep log, sleep restriction, and cognitive strategies (positive self-statements, worry management). Session 4 - Review sleep log and sleep restriction, and problem-solving barriers. Session 5 - Maintenance and relapse prevention.; Other Names: CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Conditioned Pain Modulation (CPM)	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.	1-4 weeks post-treatment
Change from baseline Temporal Summation of Pain (TS)	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.	1-4 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline score on Generalized Anxiety Disorder -7	Generalized Anxiety Disorder - 7 (GAD-7). The GAD-7 is a 7 item screener for anxiety focused on symptoms of anxiety over the past week. Each item is scores on a 0-3 scale and summed to create a total score that ranges from 0-21.	1-4 weeks post-treatment
Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).	The PHQ9-A is a validated 9 item self-report scale (4-point Likert scale) assessing symptoms of depression. Scores range from 0-27 with 0-4 indicating no or minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.	1-4 weeks post-treatment
Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)	he PANAS is a 20-item self- and parent-report measure assessing positive and negative affect. Responses are made on a 5-point Likert scale. A separate score is calculated for negative (10 items) and positive (10 items) affect and higher scores reflect higher levels of experienced affect.	1-4 weeks post-treatment
Change from baseline score on Pediatric Insomnia Severity Index (PISI)	The PISI is a 6-item parent- and child-report scale measuring insomnia severity. Total scores range from 0-30 with higher scores reflecting greater insomnia severity.	1-4 weeks post-treatment

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana Clinical and Translational Sciences Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2009842860

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No