Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/3/2014 |
| Start Date: | July 2010 |
| End Date: | November 2013 |
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).
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.
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.
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
We found this trial at
1
site
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
Click here to add this to my saved trials
