Fatigue Clinical Trial
Official title:
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 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.
Despite the effectiveness of antiretroviral treatment to maintain or restore stable health,
substantial numbers of HIV+ patients remain out of the mainstream and do not work. One
important barrier is fatigue, which is prevalent and often disabling. After months to years
of inertia and little activity, there is a need to rebuild one's life, which often requires
support, guidance, time and reinforcement. Prior placebo controlled trials of modafinil and
armodafinil to treat fatigue demonstrated efficacy. However, only 28% of those who wished to
do so returned to work. Therefore the study team developed a manualized brief behavioral
intervention, Behavioral Activation for Energy and Productivity (BA-PEP), derived from the
validated Behavioral Activation Treatment for Depression, to be used in conjunction with
armodafinil, with the primary goal of returning to work or vocational training.
The current study is a medication/behavioral intervention randomized controlled trial to test
the efficacy of armodafinil/BA-PEP vs. armodafinil/Supportive Counseling (SC) in increasing
energy, activity level and employment goal attainment for people with HIV/AIDS whose
presenting problem is clinically significant fatigue and unmet work goals. The study will
enroll HIV+ patients with clinically significant fatigue in a 4-week trial of armodafinil,
those who experience improved energy will be eligible for the counseling program and
randomized to BA-PEP or SC. To broaden the potential generalizability of the intervention,
the study will also enroll HIV+ adults who do not meet criteria for clinically significant
fatigue but who seek counseling to help them return to work. The study will be conducted at
both New York State Psychiatric Institute and Callen Lorde Community Health Center, to
examine intervention implementation within a real-world community clinic.
Primary aims: conduct a randomized clinical trial:
1. Determine if more participants in BA-PEP return to work compared to SC.
2. Determine if other outcome measures to assess behavioral activation and related
dimensions, including the Environmental Reward Observation Scale [EROS], and Behavioral
Activation for Depression Scale [BADS], differentiate response to BA-PEP and SC;
3. To identify predictors of success in work goal attainment, including moderator variables
such as concurrent Axis I depression, age, education, health history and status, time
since last employed full-time, and substance use history, as well as mediator variables
(e.g. "dose" of counseling).
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