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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 is a Phase 4 study that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 46 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01158443
The ClinicalTrials.gov registry entry for NCT01158443 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Research Foundation for Mental Hygiene, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Supportive Counseling is the first listed.
NCT01158443 reports 0 study locations.
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.
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