Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
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|ClinicalTrials.gov Identifier: NCT01158443|
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hiv Fatigue Goals||Behavioral: Behavioral Activation Therapy Behavioral: Supportive Counseling||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
Experimental: Behavioral activation therapy
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.
Behavioral: Behavioral Activation Therapy
8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.
Other Name: BA
Placebo Comparator: supportive counseling (SC)
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.
Behavioral: Supportive Counseling
8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.
- Employment or enrollment in vocational classes as measured by Goal Attainment Scaling [ Time Frame: 6 months ]Goal Attainment Scaling assesses degree of success in reaching a pre-specified set of goals initially enumerated at study entry, with a 5-point score range. A score of zero is assigned to success in attaining the specified goal, with 2 greater and 2 lesser levels of accomplishment also specified.
- Increased environmental interactions as measured by the EROS: Environmental Rewards Observation Scale. [ Time Frame: 6 months ]This is a standardized 10-item scale with a 4-point agree/disagree response format.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158443
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Judith G Rabkin, PhD||New York State Psychiatric Institute|