Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

Hiv Clinical Trial

Official title:

Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158443
• Other study ID #: 1R34MH090843
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2010
• Last updated: December 19, 2016
• Start date: July 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Goals
• Hiv

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Employment or enrollment in vocational classes as measured by Goal Attainment Scaling	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.	6 months	No
Secondary	Increased environmental interactions as measured by the EROS: Environmental Rewards Observation Scale.	This is a standardized 10-item scale with a 4-point agree/disagree response format.	6 months	No