Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Judith G. Rabkin, PhD, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01158443
First received: July 7, 2010
Last updated: March 12, 2014
Last verified: March 2014

July 7, 2010
March 12, 2014
July 2010
December 2013   (final data collection date for primary outcome measure)
Employment or enrollment in vocational classes as measured by Goal Attainment Scaling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01158443 on ClinicalTrials.gov Archive Site
Increased environmental interactions as measured by the EROS: Environmental Rewards Observation Scale. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
This is a standardized 10-item scale with a 4-point agree/disagree response format.
Same as current
Not Provided
Not Provided
 
Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV+
  • Fatigue
  • Goals
  • Behavioral: Behavioral Activation Therapy
    8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.
    Other Name: BA
  • Behavioral: Supportive Counseling
    8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.
  • 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.
    Intervention: Behavioral: Behavioral Activation Therapy
  • 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.
    Intervention: Behavioral: Supportive Counseling
Rabkin JG, McElhiney M, Rabkin R, McGrath P. Modafinil treatment for fatigue in HIV/AIDS. J Clin Psychiatry. 2010; 71:707-715

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01158443
1R34 MH090843
Yes
Judith G. Rabkin, PhD, Research Foundation for Mental Hygiene, Inc.
Research Foundation for Mental Hygiene, Inc.
Not Provided
Principal Investigator: Judith G Rabkin, PhD New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP