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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02140775
• Collaborator: Callen-Lorde Community Health Center (Other)
• Enrollment: 138
• Locations: 2
• Arms: 2
• Actual Duration (Months): 62
• Patients Per Site: 69
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection; Fatigue	Behavioral: Behavioral Activation Counseling	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
• Actual Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Behavioral Activation Therapy
Active Comparator: 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.	Behavioral: 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.; Other Names: Behavioral Activation Therapy

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Callen-Lorde Community Health Center	New York	New York	United States	10011
2	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• Callen-Lorde Community Health Center

Investigators

• Principal Investigator: Judith G Rabkin, Ph.D., MPH, Research Scientist VI

Study Documents (Full-Text)

• Study Protocol and Informed Consent Form - Nov 17, 2017
• Statistical Analysis Plan - Jul 17, 2013

More Information

Publications

None provided.

• Responsible Party: Martin McElhiney, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02140775
• Other Study ID Numbers: 6911
• First Posted: May 16, 2014
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Martin McElhiney, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute: HIV; AIDS; Fatigue; armodafinil; Unemployment
• Additional relevant MeSH terms: Fatigue

Study Results

Participant Flow

Pre-assignment Detail	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)
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

Baseline Characteristics

Arm/Group Title	Behavioral Activation Counseling	Supportive Counseling	Total
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 Participants	87	29	116
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (9.2)	46 (10.0)	47 (9.4)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	87 100%	29 100%	116 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 17.2%	9 31%	24 20.7%
Not Hispanic or Latino	72 82.8%	20 69%	92 79.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
More than one race	1 1.1%	0 0%	1 0.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	87 100%	29 100%	116 100%
Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.8 (2.6)	14.9 (2.2)	14.8 (2.5)
Time since last worked regularly (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	44	36	39
Receives Needs-based cash benefits (Count of Participants)
Count of Participants [Participants]	43 49.4%	17 58.6%	60 51.7%
Has an AIDS diagnosis (Count of Participants)
Count of Participants [Participants]	44 50.6%	15 51.7%	59 50.9%
Current Depression Diagnosis (Count of Participants)
Count of Participants [Participants]	38 43.7%	6 20.7%	44 37.9%
Recent methamphetamine use problem (Count of Participants)
Count of Participants [Participants]	19 21.8%	2 6.9%	21 18.1%

Outcome Measures

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)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Activation Counseling	Supportive Counseling
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.
Measure Participants	57	22
Count of Participants [Participants]	29 33.3%	9 31%

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
Statistical Test of Hypothesis	p-Value	.602
	Comments
	Method	Chi-squared
	Comments	degrees of freedom = 1

2. Secondary Outcome

Title	Environmental Reward Observation Scale (EROS)
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)

Outcome Measure Data

Analysis Population Description

Not all participants completed the self-report measures at the Follow-up visit.

Arm/Group Title	Behavioral Activation Counseling	Supportive Counseling
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.
Measure Participants	49	18
Mean (Standard Deviation) [units on a scale]	27 (7)	31 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Activation Counseling, Supportive Counseling
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.066
	Comments
	Method	t-test, 2 sided
	Comments
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

3. Secondary Outcome

Title	Behavioral Activation for Depression Scale (BADS)
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)

Outcome Measure Data

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)
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.
Measure Participants	49	18
Mean (Standard Deviation) [units on a scale]	99 (28)	102 (27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Activation Counseling, Supportive Counseling
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.674
	Comments
	Method	t-test, 2 sided
	Comments
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

Adverse Events

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)
Arm/Group Title	Behavioral Activation Counseling		Supportive Counseling
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/29 (0%)
Serious Adverse Events
	Behavioral Activation Counseling		Supportive Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Activation Counseling		Supportive Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.