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NCT01981096 · ClinicalTrials.gov registry record · NA

Fibromyalgia Integrative Training for Teens

A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT01981096: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01981096 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01981096, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

The purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM). Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in pain intensity than the CBT group at final study assessment (i.e., 3-month follow up). Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions in functional disability and depressive symptoms at final study assessment (i.e., 3-month follow up).

Primary Outcome

Average pain intensity in the past week marked on a paper-pencil Visual Analog Scale (Min = 0 {no pain} to Max = 10 {pain as bad as it can be}). Lower scores mean better outcomes.

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy
  • BEHAVIORAL Fibromyalgia integrative training

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2013-11
Est. Completion 2016-12
Phase NA

What the finished NCT01981096 record still lists

NCT01981096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.

NCT01981096 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01981096 about?

NCT01981096 is a clinical study titled "Fibromyalgia Integrative Training for Teens". The purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM). Hypothesis 1: Patients in the FIT Teens grou...

What is the current status of trial NCT01981096?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2013-11. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01981096?

The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Fibromyalgia integrative training (BEHAVIORAL).

Who is sponsoring clinical trial NCT01981096?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01981096's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01981096, the US trial registry maintained by the National Library of Medicine. NCT01981096 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.