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NCT00367809 · ClinicalTrials.gov registry record · Phase 3

Wellness Interventions After Transplant Study

A Phase 3 study of Organ Transplant, sponsored by National Institute of Nursing Research (NINR).

Completed
Registry status
Phase 3
Development phase
140
Enrollment target
1
Study location

NCT00367809 is a Phase 3 study of Organ Transplant that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 140 participants, above the 111-participant average among 3 other Organ Transplant trials with a reported enrollment target (26% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00367809, a Phase 3 study of Organ Transplant, has completed, sponsored by National Institute of Nursing Research (NINR).

COMPLETED
Registry status
Phase 3
Development phase
140 participants
Enrollment target
1
Study location

Study Summary

The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target. This trial is no longer recruiting new patients. Those currently enrolled will be followed for a year to evaluate trial outcomes. The purpose of this trial is to determine if training in Mindfulness-Based Stress Reduction can reduce symptom distress and improve quality of life in solid organ transplant recipients. Primary study outcomes are depression, anxiety and insomnia symptoms, measured by well-validated self-report scales. The impact of this program on objectively measured sleep outcomes, use of health care resources and costs will also be evaluated.

Conditions Studied

Interventions

  • BEHAVIORAL Health Education (HE)
  • BEHAVIORAL Delayed Intervention
  • BEHAVIORAL Mindfulness-Based Stress Reduction (MSBR)

Study Locations (1)

Minnesota

  • University of Minnesota Academic Health Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2003-08
Est. Completion 2008-05
Phase Phase 3

What the Registry Record Tells You About NCT00367809

The ClinicalTrials.gov registry entry for NCT00367809 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 111-participant average among 3 other Organ Transplant trials with a reported enrollment target (26% higher). The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Organ Transplant appearing as the primary indexed condition, and to 3 interventions - of which Health Education (HE) is the first listed.

NCT00367809 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT00367809 about?

NCT00367809 is a clinical study titled "Wellness Interventions After Transplant Study". The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target. This trial is no longer recruiting new patients. Those currently enrolled will be followed for a year to evaluate trial outcomes. The purpose of this trial is to determine if training in Mindfulness-Based St...

What is the current status of trial NCT00367809?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2003-08. Estimated completion is 2008-05.

What conditions does trial NCT00367809 study?

This clinical trial studies the following conditions: Organ Transplant.

What interventions are being tested in trial NCT00367809?

The interventions under investigation include: Health Education (HE) (BEHAVIORAL), Delayed Intervention (BEHAVIORAL), Mindfulness-Based Stress Reduction (MSBR) (BEHAVIORAL).

Who is sponsoring clinical trial NCT00367809?

This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00367809 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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