Trial Outcomes & Findings for Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS (NCT NCT02140775)
NCT ID: NCT02140775
Last Updated: 2020-03-16
Results Overview
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.
COMPLETED
NA
138 participants
GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)
2020-03-16
Participant Flow
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.
Participant milestones
| Measure |
Behavioral Activation (BA) 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.
|
Supportive Counseling (SC)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
29
|
|
Overall Study
COMPLETED
|
57
|
22
|
|
Overall Study
NOT COMPLETED
|
30
|
7
|
Reasons for withdrawal
| Measure |
Behavioral Activation (BA) 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.
|
Supportive Counseling (SC)
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
30
|
7
|
Baseline Characteristics
Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
Baseline characteristics by cohort
| Measure |
Behavioral Activation Counseling
n=87 Participants
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.
|
Supportive Counseling
n=29 Participants
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.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
46 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
47 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Education
|
14.8 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Time since last worked regularly
|
44 months
n=5 Participants
|
36 months
n=7 Participants
|
39 months
n=5 Participants
|
|
Receives Needs-based cash benefits
|
43 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Has an AIDS diagnosis
|
44 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Current Depression Diagnosis
|
38 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Recent methamphetamine use problem
|
19 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Behavioral Activation Counseling
n=57 Participants
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.
|
Supportive Counseling
n=22 Participants
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.
|
|---|---|---|
|
Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved)
|
29 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Behavioral Activation Counseling
n=49 Participants
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.
|
Supportive Counseling
n=18 Participants
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.
|
|---|---|---|
|
Environmental Reward Observation Scale (EROS)
|
27 units on a scale
Standard Deviation 7
|
31 units on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Behavioral Activation Counseling
n=49 Participants
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.
|
Supportive Counseling
n=18 Participants
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 for Depression Scale (BADS)
|
99 units on a scale
Standard Deviation 28
|
102 units on a scale
Standard Deviation 27
|
Adverse Events
Behavioral Activation Counseling
Supportive Counseling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Martin McElhiney
New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place