NCT04920630

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-10
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2021-06-10
• Last updated: 2023-08-23

Locations

1 site across 1 country: United States