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NCT01650636 · ClinicalTrials.gov registry record · NA

Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process

A NA study, sponsored by University of Miami.

Completed
Registry status
NA
Development phase
300
Enrollment target

NCT01650636: Completed NA study, sponsored by University of Miami.

NCT01650636 is a NA study that has completed, run by University of Miami. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01650636, a NA study, has completed, sponsored by University of Miami.

COMPLETED
Registry status
NA
Development phase
300 participants
Enrollment target

Study Summary

The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM) intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner Health Information (PP-T- HI) condition.

Primary Outcome

Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency acros

Interventions

  • BEHAVIORAL Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)
  • BEHAVIORAL Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2010-10
Est. Completion 2017-05
Phase NA
University of Miami

721 total trials

What the finished NCT01650636 record still lists

NCT01650636 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) is the first listed.

NCT01650636 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01650636 about?

NCT01650636 is a clinical study titled "Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process". The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syn...

What is the current status of trial NCT01650636?

This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2010-10. Estimated completion is 2017-05.

What interventions are being tested in trial NCT01650636?

The interventions under investigation include: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) (BEHAVIORAL), Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM) (BEHAVIORAL).

Who is sponsoring clinical trial NCT01650636?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01650636's enrollment target sits among peer trials

300 330th of 2000 higher than 1,630 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 NCT01650636, the US trial registry maintained by the National Library of Medicine. NCT01650636 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.