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

NCT ID: NCT04920630

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2023-05-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CBT-I

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

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy - Insomnia (CBT-I)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I

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/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.

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana Clinical and Translational Sciences Institute

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Amy E. Williams

Associate Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Riley Hospital for Childre

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

2009842860

Identifier Type: -

Identifier Source: org_study_id