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NCT01158443 · ClinicalTrials.gov registry record · Phase 4
Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
A Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT01158443: Completed Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
NCT01158443 is a Phase 4 study that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01158443, a Phase 4 study, has completed, sponsored by Research Foundation for Mental Hygiene.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is an integrated medication/behavioral intervention program to increase energy, activity level and goal attainment in a sample of HIV+ adults whose presenting problems include both clinically significant fatigue and unmet vocational goals. Based on previous studies, the investigators found that many patients fail to achieve desired goals even though energy is restored by medication. To address this failure of goal attainment, the investigators will evaluate a behavioral intervention, originally based on Behavioral Activation Treatment for Depression, and modified as Behavioral Activation Program for Energy and Productivity or BA-PEP. The intervention will be conducted with patients who experience clinically significant fatigue and who want to work or receive work-related training (paid or volunteer, part time or full time) or education once energy improves with medication (armodafinil).
Primary Outcome
Goal Attainment Scaling assesses degree of success in reaching a pre-specified set of goals initially enumerated at study entry, with a 5-point score range. A score of zero is assigned to success in attaining the specified goal, with 2 greater and 2 lesser levels of accomplishment also specified.
Interventions
- BEHAVIORAL Supportive Counseling
- BEHAVIORAL Behavioral Activation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01158443 record still lists
NCT01158443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Supportive Counseling is the first listed.
NCT01158443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01158443 about?
NCT01158443 is a clinical study titled "Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS". This is an integrated medication/behavioral intervention program to increase energy, activity level and goal attainment in a sample of HIV+ adults whose presenting problems include both clinically significant fatigue and unmet vocational goals. Based on previous studies, the investigators found that...
What is the current status of trial NCT01158443?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2010-07. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01158443?
The interventions under investigation include: Supportive Counseling (BEHAVIORAL), Behavioral Activation Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01158443?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01158443's enrollment target sits among peer trials
46 1348th of 2000 higher than 647 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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