- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140775
Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite the effectiveness of antiretroviral treatment to maintain or restore stable health, substantial numbers of HIV+ patients remain out of the mainstream and do not work. One important barrier is fatigue, which is prevalent and often disabling. After months to years of inertia and little activity, there is a need to rebuild one's life, which often requires support, guidance, time and reinforcement. Prior placebo controlled trials of modafinil and armodafinil to treat fatigue demonstrated efficacy. However, only 28% of those who wished to do so returned to work. Therefore the study team developed a manualized brief behavioral intervention, Behavioral Activation for Energy and Productivity (BA-PEP), derived from the validated Behavioral Activation Treatment for Depression, to be used in conjunction with armodafinil, with the primary goal of returning to work or vocational training.
The current study is a medication/behavioral intervention randomized controlled trial to test the efficacy of armodafinil/BA-PEP vs. armodafinil/Supportive Counseling (SC) in increasing energy, activity level and employment goal attainment for people with HIV/AIDS whose presenting problem is clinically significant fatigue and unmet work goals. The study will enroll HIV+ patients with clinically significant fatigue in a 4-week trial of armodafinil, those who experience improved energy will be eligible for the counseling program and randomized to BA-PEP or SC. To broaden the potential generalizability of the intervention, the study will also enroll HIV+ adults who do not meet criteria for clinically significant fatigue but who seek counseling to help them return to work. The study will be conducted at both New York State Psychiatric Institute and Callen Lorde Community Health Center, to examine intervention implementation within a real-world community clinic.
Primary aims: conduct a randomized clinical trial:
- Determine if more participants in BA-PEP return to work compared to SC.
- Determine if other outcome measures to assess behavioral activation and related dimensions, including the Environmental Reward Observation Scale [EROS], and Behavioral Activation for Depression Scale [BADS], differentiate response to BA-PEP and SC;
- To identify predictors of success in work goal attainment, including moderator variables such as concurrent Axis I depression, age, education, health history and status, time since last employed full-time, and substance use history, as well as mediator variables (e.g. "dose" of counseling).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
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New York, New York, United States, 10011
- Callen-Lorde Community Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV+, age 18-70, and under the care of a medical provider
- Clinically significant fatigue (Score of 4.5+ on Fatigue Severity Scale) and impairment on at least one category of role function (MOS) with duration of 3+ months (Does not apply to the cohort without fatigue)
- Speaks English (reads English at high school level or shows comprehension in Evaluation to Consent procedure).
- Able and willing to give informed consent
- (Fecund Women): Uses barrier method of contraception
- Patient seeks either work or job-related training
Exclusion Criteria:
- Untreated Major Depression: (Structured Clinical Interview for Diagnostic and Statistical Manual IV (DSM-IV), (SCID) Depression Module;17-item Hamilton Rating Scale for Depression (HAM-D) >18).
- Untreated hypogonadism, hypothyroidism or anemia (labs out of range).
- Unstable medical condition
- Left ventricular hypertrophy; symptomatic mitral valve prolapse (EKG; medical history)
- Started testosterone in past 4 weeks
- Started antidepressant medication in past 6 weeks
- Substance abuse/dependence
- Current clinically significant suicidal ideation
- History or current psychosis or bipolar disorder
- Pregnancy or breast feeding
- Untreated insomnia (Score>3 on 3 HAM-D sleep items).
- Currently taking stimulant medication of past non-responder to armodafinil
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Activation Counseling
Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change.
The individual sessions last one hour and are scheduled every two weeks.
The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
|
Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change.
The individual sessions last one hour and are scheduled every two weeks.
The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
Other Names:
|
Active Comparator: Supportive Counseling
Supportive Counseling sessions will follow the same schedule and the Behavioral Activation Counseling, meeting for one hour every two weeks.
The content of the sessions will be guided by the participant.
The counselor will provide an accepting environment for the participant to explore his/her feelings about these topics.
|
Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change.
The individual sessions last one hour and are scheduled every two weeks.
The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved)
Time Frame: GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)
|
Goal Attainment Scale - Prior to the beginning of counseling, the patient met with a member of the clinical team to develop an outcome GAS scale specific to their personal return to work goal. A goal was carefully established to be obtainable within the framework of 3-6 months, and to have observable anchors that could be scored on 3 outcome levels. A score of 3 indicates that they achieved their predetermined work goal and they were considered a "Responder" to the counseling. A score 2 indicates that some of the specific steps were taken towards the goal, but that it was not fully achieved. A score of 1 indicates that few or no steps were taken. Participants who scored 1 or 2 on their GAS scale were considered to be "Non-Responders." The Primary outcome presented below includes the number of participants who achieved their work-related goal (a score on the GAS scale of 3) and are considered RESPONDERS to counseling. |
GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Environmental Reward Observation Scale (EROS)
Time Frame: EROS will be measured at Follow-up (3-6 months after the end of counseling)
|
This 10-item scale developed to assess changes in activity level and is based on the premise of response-contingent reinforcement. Score Range = 10 - 40 Higher scores suggest higher environmental reward. |
EROS will be measured at Follow-up (3-6 months after the end of counseling)
|
Behavioral Activation for Depression Scale (BADS)
Time Frame: BADS will be measured Follow-up (3-6 months after the end of counseling)
|
This 25 item scale total score is used to monitor change in Behavioral Activation (BA) protocols. Score Range = 0 - 150 Higher scores suggest greater activation and less avoidance, as well as less social and work impairment. |
BADS will be measured Follow-up (3-6 months after the end of counseling)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Judith G Rabkin, Ph.D., MPH, Research Scientist VI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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