Fatigue Clinical Trial
Official title:
Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
NCT number | NCT02140775 |
Other study ID # | 6911 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2014 |
Est. completion date | May 31, 2019 |
Verified date | March 2020 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | May 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. HIV+, age 18-70, and under the care of a medical provider 2. 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) 3. Speaks English (reads English at high school level or shows comprehension in Evaluation to Consent procedure). 4. Able and willing to give informed consent 5. (Fecund Women): Uses barrier method of contraception 6. Patient seeks either work or job-related training Exclusion Criteria: 1. 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). 2. Untreated hypogonadism, hypothyroidism or anemia (labs out of range). 3. Unstable medical condition 4. Left ventricular hypertrophy; symptomatic mitral valve prolapse (EKG; medical history) 5. Started testosterone in past 4 weeks 6. Started antidepressant medication in past 6 weeks 7. Substance abuse/dependence 8. Current clinically significant suicidal ideation 9. History or current psychosis or bipolar disorder 10. Pregnancy or breast feeding 11. Untreated insomnia (Score>3 on 3 HAM-D sleep items). 12. Currently taking stimulant medication of past non-responder to armodafinil |
Country | Name | City | State |
---|---|---|---|
United States | Callen-Lorde Community Health Center | New York | New York |
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Callen-Lorde Community Health Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Environmental Reward Observation Scale (EROS) | 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) | |
Secondary | Behavioral Activation for Depression Scale (BADS) | 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) |
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