Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
Condition: HIV Infection; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Behavioral Activation Counseling
Intervention type(s): Behavioral
Intervention description(s): Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The individual sessions last one hour and are scheduled every two weeks. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
Other intervention name(s): Behavioral Activation Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; AIDS; Fatigue; armodafinil; Unemployment