Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
NCT ID: NCT01158443
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
46 participants
INTERVENTIONAL
2010-07-31
2014-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 Activation Therapy
8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.
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.
Supportive Counseling
8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.
Interventions
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Behavioral Activation Therapy
8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.
Supportive Counseling
8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Research Foundation for Mental Hygiene, Inc.
OTHER
Responsible Party
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Judith G. Rabkin, PhD
Research Scientist VI
Principal Investigators
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Judith G Rabkin, PhD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
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New York State Psychiatric Institute
New York, New York, United States
Countries
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References
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Rabkin JG, McElhiney MC, Rabkin R, McGrath PJ. Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study. J Clin Psychiatry. 2010 Jun;71(6):707-15. doi: 10.4088/JCP.09m05171bro. Epub 2010 May 4.
Other Identifiers
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