Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
1 other identifier
interventional
138
1 country
2
Brief Summary
The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with clinically significant fatigue whose energy has improved with armodafinil, who have the goal of returning to work or vocational training but have not done so on their own. A second cohort of HIV+ participants without significant fatigue at baseline, but who also have the goal of returning to work, will also be randomized to either Behavioral Activation counseling or supportive counseling. In both cohorts, the primary outcome is level of success regarding an employment related goal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 18, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedResults Posted
Study results publicly available
March 16, 2020
CompletedMarch 16, 2020
March 1, 2020
5 years
April 18, 2014
January 28, 2020
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved)
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 Outcomes (2)
Environmental Reward Observation Scale (EROS)
EROS will be measured at Follow-up (3-6 months after the end of counseling)
Behavioral Activation for Depression Scale (BADS)
BADS will be measured Follow-up (3-6 months after the end of counseling)
Study Arms (2)
Behavioral Activation Counseling
EXPERIMENTALBehavioral 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.
Supportive Counseling
ACTIVE COMPARATORSupportive 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Callen-Lorde Community Health Center
New York, New York, 10011, United States
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Martin McElhiney
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Judith G Rabkin, Ph.D., MPH
Research Scientist VI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Psychiatry
Study Record Dates
First Submitted
April 18, 2014
First Posted
May 16, 2014
Study Start
April 1, 2014
Primary Completion
March 31, 2019
Study Completion
May 31, 2019
Last Updated
March 16, 2020
Results First Posted
March 16, 2020
Record last verified: 2020-03