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

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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

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE May 16, 2014
Results First Submitted Date  ICMJE January 28, 2020
Results First Posted Date  ICMJE March 16, 2020
Last Update Posted Date March 16, 2020
Actual Study Start Date  ICMJE April 1, 2014
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2020)
Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
Goal Attainment Scale - Modified (GAS) [ Time Frame: GAS will be assessed at week 16 (end of counseling) ]
Goal Attainment Scale - Modified is scored in 3 categories: 1) minimal to no action; 2) steps taken, and 3) goal achieved. Patient and staff together define a primary obtainable work or training-related goal within a framework of 3-6 months, and establish observable anchors prior to the initiation of counseling.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2020)
  • Environmental Reward Observation Scale (EROS) [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
  • Environmental Reward Observation Scale (EROS) [ Time Frame: EROS will be measured at week 16 (end of counseling) and at 1 month Follow-up and 3 month Follow-up ]
    This 10-item scale developed to assess changes in activity level.
  • Behavioral Activation for Depression Scale (BADS) [ Time Frame: BADS will be measured at week 16 (end of counseling) and at 1 month Follow-up and 3 month Follow-up ]
    This 25 item scale includes subscale scores for activation, avoidance/rumination, work/school impairment, social impairment, and also a total score. It is used to monitor change in BA protocols.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
Official Title  ICMJE Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • Fatigue
Intervention  ICMJE 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 Name: Behavioral Activation Therapy
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Behavioral Activation Counseling
  • 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.
    Intervention: Behavioral: Behavioral Activation Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
138
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2014)
140
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02140775
Other Study ID Numbers  ICMJE 6911
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin McElhiney, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Callen-Lorde Community Health Center
Investigators  ICMJE
Principal Investigator: Judith G Rabkin, Ph.D., MPH Research Scientist VI
PRS Account New York State Psychiatric Institute
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP