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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2019

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

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • New York State Psychiatric Institute
  • Collaborator
    • Callen-Lorde Community Health Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Judith Rabkin, Research Scientist VI – New York State Psychiatric Institute
  • Overall Official(s)
    • Judith G Rabkin, Ph.D., MPH, Principal Investigator, Research Scientist VI

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