Study Summary
This trial is studying how insomnia contributes to chronic pain in youth and whether treating insomnia can help. Teens with chronic pain and insomnia will be enrolled and asked to complete questionnaires and pain assessments. They will also participate in a 5-session virtual group CBT-I intervention, and have follow-up assessments.
- Insomnia
- Chronic Pain
Treatment Effectiveness
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: 1-4 weeks post-treatment
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
CBT-I
1 of 1
Experimental Treatment
60 Total Participants · 1 Treatment Group
Primary Treatment: Cognitive Behavioral Therapy - Insomnia (CBT-I) · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 12 - 17 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is the lower age limit for this research study 25 years old or younger?
"This clinical trial is exclusively open to teenagers between the ages of 12 and 17. Comparatively, there are 55 trials suitable for minors and 536 available treatment plans targeting seniors above 65 years old." - Anonymous Online Contributor
What are the primary goals of this clinical experiment?
"This experiment's primary purpose is to measure the temporal summation of pain (TS) over a period ranging from one to four weeks post-treatment. Secondary goals include assessing insomnia severity with the Pediatric Insomnia Severity Index (PISI), monitoring anxiety levels with the Generalized Anxiety Disorder - 7 scale, and using Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A) for depression measurement." - Anonymous Online Contributor
What is the current capacity of participants in this experiment?
"Indeed, according to the information on clinicialtrials.gov this clinical trial is presently recruiting candidates. It was first published on May 10th 2021 and edited for the last time in August 1st 2022; thus far 60 patients have been recruited at a single site." - Anonymous Online Contributor
Is enrollment open at this juncture for the trial?
"As indicated on the clinicaltrials.gov database, this research protocol is open to new participants. It was first launched on May 10th 2021 and most recently updated on August 1st 2022." - Anonymous Online Contributor
Is it possible for me to take part in this clinical experiment?
"Qualified candidates must suffer from chronic pain and be between 12 to 17 years old in order to partake in this clinical trial. There are 60 spots available for potential participants." - Anonymous Online Contributor