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

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).

Inclusion Criteria:

1. HIV+, age 18-70, and under the care of a medical provider

2. 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)

3. Speaks English (reads English at high school level or shows comprehension in
Evaluation to Consent procedure).

4. Able and willing to give informed consent

5. (Fecund Women): Uses barrier method of contraception

6. Patient seeks either work or job-related training

Exclusion Criteria:

1. 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).

2. Untreated hypogonadism, hypothyroidism or anemia (labs out of range).

3. Unstable medical condition

4. Left ventricular hypertrophy; symptomatic mitral valve prolapse (EKG; medical history)

5. Started testosterone in past 4 weeks

6. Started antidepressant medication in past 6 weeks

7. Substance abuse/dependence

8. Current clinically significant suicidal ideation

9. History or current psychosis or bipolar disorder

10. Pregnancy or breast feeding

11. Untreated insomnia (Score>3 on 3 HAM-D sleep items).

12. Currently taking stimulant medication of past non-responder to armodafinil