Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
Condition: Hiv; Fatigue; Goals
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

Detailed description: 
      The investigators propose an integrated medication/behavioral intervention program to
      increase energy, activity level and goal attainment in a sample of people with HIV/AIDS whose
      presenting problem is clinically significant fatigue and unmet vocational goals. Based on a
      recently completed randomized controlled trial (RCT) of modafinil and ongoing RCT of
      armodafinil, 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 team
      will develop and pilot a behavioral intervention, originally based on Behavioral Activation
      Treatment for Depression of Lejuez et al. and modified by Dr. Daughters as "Behavioral
      Activation Program for Energy and Productivity, or 'BA-PEP'". The intervention will be
      conducted with patients who experience significant fatigue, and who want to work or get
      work-related training or education once their energy improves with armodafinil treatment. It
      is intended for eventual implementation in HIV clinics and community agencies with work
      development programs.

      The intervention development includes both formative work and pilot studies. The formative
      work comprises in-depth patient interviews, focus groups with providers, a Project Advisory
      Board, and a separate Work Group. Their input will be used to modify their BA-PEP
      intervention to promote achievement of goals selected by each patient, once fatigue has been
      ameliorated with armodafinil, and to further adapt the attention control supportive
      counseling intervention.

      With this input, the investigators will conduct an exploratory study using BA-PEP with 12
      patients responsive to armodafinil. After further modifications, investigators will conduct a
      feasibility trial with 30 armodafinil-responsive patients randomized 2:1 to BA-PEP or an
      attention control, supportive counseling. The main behavioral outcome is employment or taking
      classes (measured by Goal Attainment Scaling methodology). Secondary outcomes are reduced
      avoidance/increased activation (measured by the Behavioral Activation for Depression Scale),
      and increased environmental interactions (measured by the EROS: Environmental Rewards
      Observation Scale). Finally, they will develop training and supervision manuals to guide
      implementation.
    

Intervention name(s): Behavioral Activation Therapy; Supportive Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.; 8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.
Other intervention name(s): BA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV+; fatigue; return to work