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

Riley Hospital for Childre, Indianapolis, IN
Insomnia+1 More ConditionsCognitive Behavioral Therapy - Insomnia (CBT-I) - Behavioral
12 - 17
All Sexes

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

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 1-4 weeks post-treatment

1-4 weeks post-treatment
Change from Baseline Score on Positive and Negative Affect Schedule (PANAS)
Change from baseline Conditioned Pain Modulation (CPM)
Change from baseline Temporal Summation of Pain (TS)
Change from baseline score on Generalized Anxiety Disorder -7
Change from baseline score on Patient Health Questionnaire - 9 Adolescent Form (PHQ9-A).

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Cognitive Behavioral Therapy - Insomnia (CBT-I) · No Placebo Group · N/A

Experimental Group · 1 Intervention: Cognitive Behavioral Therapy - Insomnia (CBT-I) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-4 weeks post-treatment

Who is running the clinical trial?

Indiana UniversityLead Sponsor
914 Previous Clinical Trials
775,768 Total Patients Enrolled
6 Trials studying Insomnia
3,673 Patients Enrolled for Insomnia
Indiana Clinical and Translational Sciences InstituteOTHER
18 Previous Clinical Trials
5,271 Total Patients Enrolled

Eligibility Criteria

Age 12 - 17 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have epilepsy, a condition that causes seizures.
You have a history of bipolar disorder or experiencing manic episodes.
You have a medical history of Raynaud Syndrome.
You have had thoughts or intentions of harming yourself in the past month.
You have a history of heart or nerve/muscle problems.
You have trouble sleeping, with or without long-lasting pain in your muscles and bones.
You have a history of sleep disorders like sleep apnea, restless leg syndrome or narcolepsy.

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

Unverified Answer

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

Unverified Answer

What is the current capacity of participants in this experiment?

"Indeed, according to the information on 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

Unverified Answer

Is enrollment open at this juncture for the trial?

"As indicated on the 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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.