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NCT04920630 · ClinicalTrials.gov registry record · NA
TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT04920630 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 26 participants.
The verdict
NCT04920630, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study 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).
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy - Insomnia (CBT-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2023-05-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04920630
The ClinicalTrials.gov registry entry for NCT04920630 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy - Insomnia (CBT-I) is the first listed.
NCT04920630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04920630 about?
NCT04920630 is a clinical study titled "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 p...
What is the current status of trial NCT04920630?
This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2021-05-10. Estimated completion is 2023-05-05.
What interventions are being tested in trial NCT04920630?
The interventions under investigation include: Cognitive Behavioral Therapy - Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04920630?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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