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Behavioral Intervention

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

N/A

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-4 weeks post-treatment

Awards & highlights

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.

Eligible Conditions

Insomnia
Chronic Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-4 weeks post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-4 weeks post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline Conditioned Pain Modulation (CPM)

Change from baseline Temporal Summation of Pain (TS)

Secondary outcome measures

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

Change from baseline score on Generalized Anxiety Disorder -7

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

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CBT-IExperimental Treatment1 Intervention

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

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,135 Total Patients Enrolled

7 Trials studying Insomnia

3,873 Patients Enrolled for Insomnia

Indiana Clinical and Translational Sciences InstituteOTHER

19 Previous Clinical Trials

4,647 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Amy E. Williams 2021. "TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04920630.