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

NCT04920630 | Terminated DMC

• 1 other identifier: 2009842860
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change from baseline score on Generalized Anxiety Disorder -7

  1-4 weeks post-treatment

• Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).

  1-4 weeks post-treatment

• Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)

  1-4 weeks post-treatment

• Change from baseline score on Pediatric Insomnia Severity Index (PISI)

  1-4 weeks post-treatment

Study Arms (1)

CBT-I

EXPERIMENTAL

5-weekly Cognitive Behavioral Therapy for Insomnia group therapy sessions conducted virtually.

Behavioral: Cognitive Behavioral Therapy - Insomnia (CBT-I)

Interventions

Cognitive Behavioral Therapy - Insomnia (CBT-I) BEHAVIORAL

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.

Also known as: CBT-I

CBT-I

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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/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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Indiana Clinical and Translational Sciences Institute: collaborator

Study Sites (1)

Riley Hospital for Childre

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 10, 2021
• Study Start: May 10, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

US (1)