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Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

NCT01158443 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-12-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

Behavioral Activation Therapy

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

BEHAVIORAL

Supportive Counseling

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

Sponsors & Collaborators

  • Research Foundation for Mental Hygiene, Inc.

    lead OTHER

Principal Investigators

  • Judith G Rabkin, PhD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158443 on ClinicalTrials.gov