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
  Purpose

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).


Condition Intervention Phase
HIV+
Fatigue
Goals
Behavioral: Behavioral Activation Therapy
Behavioral: Supportive Counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: July 2010
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158443

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Judith G Rabkin, PhD New York State Psychiatric Institute
  More Information

Publications:
Rabkin JG, McElhiney M, Rabkin R, McGrath P. Modafinil treatment for fatigue in HIV/AIDS. J Clin Psychiatry. 2010; 71:707-715

Responsible Party: Judith G. Rabkin, PhD, Research Scientist VI, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01158443     History of Changes
Other Study ID Numbers: 1R34 MH090843
Study First Received: July 7, 2010
Last Updated: March 12, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Research Foundation for Mental Hygiene, Inc.:
HIV+
fatigue
return to work

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014