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NCT03134950 · ClinicalTrials.gov registry record · NA

Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach

A NA study, sponsored by Michigan State University.

Completed
Registry status
NA
Development phase
139
Enrollment target

NCT03134950 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 139 participants.

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The verdict

NCT03134950, a NA study, has completed, sponsored by Michigan State University.

COMPLETED
Registry status
NA
Development phase
139 participants
Enrollment target

Study Summary

This project aims to test a stepped care behavioral intervention approach for youth with functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth with FAP with more than minimal functional disability (FDI score \>7) during their medical visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those that fail to respond to EUC (as evidenced by FDI score \>7) are eligible to undergo a baseline assessment and then are randomized to receive either 1) a more intensive and tailored CBT approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.

Interventions

  • BEHAVIORAL ADAPT

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2015-07-20
Est. Completion 2018-02-08
Phase NA

Sponsor

Michigan State University

120 total trials

What the Registry Record Tells You About NCT03134950

The ClinicalTrials.gov registry entry for NCT03134950 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ADAPT is the first listed.

NCT03134950 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03134950 about?

NCT03134950 is a clinical study titled "Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach". This project aims to test a stepped care behavioral intervention approach for youth with functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth with FAP with more than...

What is the current status of trial NCT03134950?

This trial is currently completed. It is a NA study. The enrollment target is 139 participants. The study started on 2015-07-20. Estimated completion is 2018-02-08.

What interventions are being tested in trial NCT03134950?

The interventions under investigation include: ADAPT (BEHAVIORAL).

Who is sponsoring clinical trial NCT03134950?

This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.