Fatigue, HIV Infection
Conditions
Keywords
HIV, AIDS, Fatigue, armodafinil, Unemployment
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.
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: 1. Determine if more participants in BA-PEP return to work compared to SC. 2. 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; 3. 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).
Interventions
BEHAVIORALBehavioral 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.
Sponsors
Callen-Lorde Community Health Center
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Environmental Reward Observation Scale (EROS) | 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. |
| Behavioral Activation for Depression Scale (BADS) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of the 138 patients who entered the study, 73 presented with significant fatigue and were started on armodafinil. Of those, 51 had an adequate response to the medication and were randomized to counseling. Another 65 patients did not have fatigue and were randomized directly to counseling. In total, 116 patients started counseling.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 87 |
| 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. | 29 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 30 | 7 |
Baseline characteristics
| Characteristic | Behavioral Activation Counseling | Supportive Counseling | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 9.2 | 46 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 9.4 |
| Current Depression Diagnosis | 38 Participants | 6 Participants | 44 Participants |
| Education | 14.8 years STANDARD_DEVIATION 2.6 | 14.9 years STANDARD_DEVIATION 2.2 | 14.8 years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 9 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 20 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Has an AIDS diagnosis | 44 Participants | 15 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 11 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 18 Participants | 80 Participants |
| Receives Needs-based cash benefits | 43 Participants | 17 Participants | 60 Participants |
| Recent methamphetamine use problem | 19 Participants | 2 Participants | 21 Participants |
| Region of Enrollment United States | 87 Participants | 29 Participants | 116 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 87 Participants | 29 Participants | 116 Participants |
| Time since last worked regularly | 44 months | 36 months | 39 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 29 |
| other Total, other adverse events | 0 / 87 | 0 / 29 |
| serious Total, serious adverse events | 0 / 87 | 0 / 29 |
Outcome results
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.
Time frame: GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Activation Counseling | Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved) | 29 Participants |
| Supportive Counseling | Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved) | 9 Participants |
Comparison: A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.p-value: 0.602Chi-squared
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.
Time frame: BADS will be measured Follow-up (3-6 months after the end of counseling)
Population: Not all participants completed the self-report measures at the Follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation Counseling | Behavioral Activation for Depression Scale (BADS) | 99 units on a scale | Standard Deviation 28 |
| Supportive Counseling | Behavioral Activation for Depression Scale (BADS) | 102 units on a scale | Standard Deviation 27 |
p-value: 0.67495% CI: [-18.59, 12.09]t-test, 2 sided
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.
Time frame: EROS will be measured at Follow-up (3-6 months after the end of counseling)
Population: Not all participants completed the self-report measures at the Follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation Counseling | Environmental Reward Observation Scale (EROS) | 27 units on a scale | Standard Deviation 7 |
| Supportive Counseling | Environmental Reward Observation Scale (EROS) | 31 units on a scale | Standard Deviation 8 |
p-value: 0.06695% CI: [-7.75, 0.26]t-test, 2 sided