Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
Completed · Phase 4
Conditions studied: Hiv, Fatigue, Goals
In brief
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).
Key facts
- Study ID
- NCT01158443
- Run by
- Research Foundation for Mental Hygiene, Inc.
- People needed
- 46
- Starts
- 2010-07-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2016-12-21
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HIV+, ages 18-70
- Under the care of a medical provider
- Clinically significant fatigue
- Speaks English
- Able and willing to give informed consent
- Patient seeks either work or vocational training but is blocked from doing so by current fatigue
You may not qualify if…
- Primary care provider does not approve of study participation
- Medical rule-outs such as anemia, hypothyroidism, hypogonadism or other condition that may account for fatigue
- Abnormal EKG
- Untreated major depressive disorder; psychosis, bipolar disorder
- Current substance abuse/dependence
- Clinically significant suicidal ideation
Where it is running
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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