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Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140775
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
Callen-Lorde Community Health Center
Information provided by (Responsible Party):
Martin McElhiney, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infection
Fatigue
Intervention Behavioral: Behavioral Activation Counseling
Enrollment 138
Recruitment Details  
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.
Arm/Group Title Behavioral Activation (BA) Counseling Supportive Counseling (SC)
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 87 29
Completed 57 22
Not Completed 30 7
Reason Not Completed
Withdrawal by Subject             30             7
Arm/Group Title Behavioral Activation Counseling Supportive Counseling Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 87 29 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 29 participants 116 participants
47  (9.2) 46  (10.0) 47  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
87
 100.0%
29
 100.0%
116
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
Hispanic or Latino
15
  17.2%
9
  31.0%
24
  20.7%
Not Hispanic or Latino
72
  82.8%
20
  69.0%
92
  79.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
24
  27.6%
11
  37.9%
35
  30.2%
White
62
  71.3%
18
  62.1%
80
  69.0%
More than one race
1
   1.1%
0
   0.0%
1
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 87 participants 29 participants 116 participants
87
 100.0%
29
 100.0%
116
 100.0%
Education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 29 participants 116 participants
14.8  (2.6) 14.9  (2.2) 14.8  (2.5)
Time since last worked regularly  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 87 participants 29 participants 116 participants
44
(3 to 300)
36
(1 to 240)
39
(1 to 300)
Receives Needs-based cash benefits  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
43
  49.4%
17
  58.6%
60
  51.7%
Has an AIDS diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
44
  50.6%
15
  51.7%
59
  50.9%
Current Depression Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
38
  43.7%
6
  20.7%
44
  37.9%
Recent methamphetamine use problem  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 29 participants 116 participants
19
  21.8%
2
   6.9%
21
  18.1%
1.Primary Outcome
Title Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Counseling Supportive Counseling
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 57 22
Measure Type: Count of Participants
Unit of Measure: Participants
29
  50.9%
9
  40.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Activation Counseling, Supportive Counseling
Comments A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .602
Comments [Not Specified]
Method Chi-squared
Comments degrees of freedom = 1
2.Secondary Outcome
Title Environmental Reward Observation Scale (EROS)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants completed the self-report measures at the Follow-up visit.
Arm/Group Title Behavioral Activation Counseling Supportive Counseling
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 49 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
27  (7) 31  (8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Activation Counseling, Supportive Counseling
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .066
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.74
Confidence Interval (2-Sided) 95%
-7.75 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.00
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Behavioral Activation for Depression Scale (BADS)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all participants completed the self-report measures at the Follow-up visit.
Arm/Group Title Behavioral Activation (BA) Counseling Supportive Counseling (SC)
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 49 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
99  (28) 102  (27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavioral Activation (BA) Counseling, Supportive Counseling (SC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .674
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.25
Confidence Interval (2-Sided) 95%
-18.59 to 12.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.68
Estimation Comments [Not Specified]
Time Frame The time frame included data collected from baseline until the final visit at follow up (3-6 months after the end of counseling)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Activation Counseling Supportive Counseling
Hide Arm/Group Description 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 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. 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.
All-Cause Mortality
Behavioral Activation Counseling Supportive Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/29 (0.00%) 
Hide Serious Adverse Events
Behavioral Activation Counseling Supportive Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Activation Counseling Supportive Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/29 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Martin McElhiney
Organization: New York State Psychiatric Institute
Phone: 646.774.8035
EMail: mcelhin@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Martin McElhiney, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02140775    
Other Study ID Numbers: 6911
First Submitted: April 18, 2014
First Posted: May 16, 2014
Results First Submitted: January 28, 2020
Results First Posted: March 16, 2020
Last Update Posted: March 16, 2020