Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

NCT01158443 | Completed Phase 4 DMC

• 1 other identifier: 1R34MH090843
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hiv; Fatigue; Goals

Keywords

HIV+; fatigue; return to work

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Increased environmental interactions as measured by the EROS: Environmental Rewards Observation Scale.

  6 months

Study Arms (2)

Behavioral activation therapy

EXPERIMENTAL

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

supportive counseling (SC)

PLACEBO COMPARATOR

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

Interventions

Behavioral Activation Therapy BEHAVIORAL

8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.

Also known as: BA

Behavioral activation therapy

Supportive Counseling BEHAVIORAL

8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.

supportive counseling (SC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related 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. Epub 2010 May 4.

  PMID: 20492840 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Fatigue

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith G Rabkin, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist VI

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: December 21, 2016

Record last verified: 2014-03

Locations

US (1)