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NCT02140775 · ClinicalTrials.gov registry record · NA

Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS

A NA study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
NA
Development phase
138
Enrollment target

NCT02140775: Completed NA study, sponsored by New York State Psychiatric Institute.

NCT02140775 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 138 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02140775, a NA study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
NA
Development phase
138 participants
Enrollment target

Study Summary

The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with clinically significant fatigue whose energy has improved with armodafinil, who have the goal of returning to work or vocational training but have not done so on their own. A second cohort of HIV+ participants without significant fatigue at baseline, but who also have the goal of returning to work, will also be randomized to either Behavioral Activation counseling or supportive counseling. In both cohorts, the primary outcome is level of success regarding an employment related goal.

Primary Outcome

Goal Attainment Scale - Prior to the beginning of counseling, the patient met with a member of the clinical team to develop an outcome GAS scale specific to their personal return to work goal. A goal was carefully established to be obtainable within the framework of 3-6 months, and to have observable anchors that could be scored on 3 outcome levels. A score of 3 indicates that they achieved their predetermined work goal and they were considered a "Responder" to the counseling. A score 2 indicate

Interventions

  • BEHAVIORAL Behavioral Activation Counseling

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2014-04-01
Est. Completion 2019-05-31
Phase NA

What the finished NCT02140775 record still lists

NCT02140775 is an interventional study that assigns participants to a tested intervention. The registered 138 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 (90% lower).

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

NCT02140775 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02140775 about?

NCT02140775 is a clinical study titled "Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS". The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with clinically significant fatigue whose energy has improved with armodafinil, who have the goal of returning to work or vocational training but ha...

What is the current status of trial NCT02140775?

This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2014-04-01. Estimated completion is 2019-05-31.

What interventions are being tested in trial NCT02140775?

The interventions under investigation include: Behavioral Activation Counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT02140775?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02140775's enrollment target sits among peer trials

138 720th of 2000 higher than 1,279 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 NCT02140775, the US trial registry maintained by the National Library of Medicine. NCT02140775 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.