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

Completed · Not applicable

Conditions studied: HIV Infection, Fatigue

In brief

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.

Key facts

Study ID

NCT02140775

Run by

New York State Psychiatric Institute

People needed

138

Starts

2014-04-01

Expected to finish

2019-05-31

Last updated by the study team

2020-03-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV+, age 18-70, and under the care of a medical provider
• Clinically significant fatigue (Score of 4.5+ on Fatigue Severity Scale) and impairment on at least one category of role function (MOS) with duration of 3+ months (Does not apply to the cohort without fatigue)
• Speaks English (reads English at high school level or shows comprehension in Evaluation to Consent procedure).
• Able and willing to give informed consent
• (Fecund Women): Uses barrier method of contraception
• Patient seeks either work or job-related training

You may not qualify if…

• Untreated Major Depression: (Structured Clinical Interview for Diagnostic and Statistical Manual IV (DSM-IV), (SCID) Depression Module;17-item Hamilton Rating Scale for Depression (HAM-D) >18).
• Untreated hypogonadism, hypothyroidism or anemia (labs out of range).
• Unstable medical condition
• Left ventricular hypertrophy; symptomatic mitral valve prolapse (EKG; medical history)
• Started testosterone in past 4 weeks
• Started antidepressant medication in past 6 weeks
• Substance abuse/dependence
• Current clinically significant suicidal ideation
• History or current psychosis or bipolar disorder
• Pregnancy or breast feeding
• Untreated insomnia (Score>3 on 3 HAM-D sleep items).
• Currently taking stimulant medication of past non-responder to armodafinil

Where it is running

• Callen-Lorde Community Health Center — New York, New York, United States
• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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