Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

Research Foundation for Mental Hygiene (RFMH)

Status and phase: Completed; Phase 4

Conditions: Goals; Fatigue; Hiv

Treatments: Behavioral: Supportive Counseling; Behavioral: Behavioral Activation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01158443

1R34MH090843

Details and patient eligibility

About

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).

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV+, ages 18-70
• Under the care of a medical provider
• Clinically significant fatigue
• Speaks English
• Able and willing to give informed consent
• Patient seeks either work or vocational training but is blocked from doing so by current fatigue

Exclusion criteria

• Primary care provider does not approve of study participation
• Medical rule-outs such as anemia, hypothyroidism, hypogonadism or other condition that may account for fatigue
• Abnormal EKG
• Untreated major depressive disorder; psychosis, bipolar disorder
• Current substance abuse/dependence
• Clinically significant suicidal ideation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Behavioral activation therapy

Experimental group

Description:

The Behavioral Activation Program for Energy and Productivity (BA-PEP) is a manualized, 8-session intervention, scheduled to coincide with maintenance armodafinil treatment. It is a structured counseling program with homework, short-term activities and goals, and includes problem-solving, identification of barriers and strategies for their resolution, with an ongoing focus on achieving employment or training.

Treatment:

Behavioral: Behavioral Activation Therapy

supportive counseling (SC)

Placebo Comparator group

Description:

Supportive counseling is designed to create an empathic, accepting environment, to direct attention to the patient's feelings and to facilitate acceptance of affective experience using supportive statements, reflective listening and empathic communications.

Treatment:

Behavioral: Supportive Counseling