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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2016 by New York State Psychiatric Institute

Sponsor
New York State Psychiatric Institute

Collaborator
Callen-Lorde Community Health Center

Information provided by (Responsible Party)
New York State Psychiatric Institute
ClinicalTrials.gov Identifier
NCT02140775

First received: April 18, 2014
Last updated: December 20, 2016
Last Verified: December 2016
History of Changes
Purpose

Purpose

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 Intervention
HIV Infection
Fatigue

Behavioral : Behavioral Activation Counseling

Study Type: Interventional
Study Design: 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

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome 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 Outcome 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.

Estimated Enrollment: 140
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: Behavioral Activation Therapy

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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02140775

Contacts

Contact:   Judith G Rabkin, Ph.D., MPH 646.774.8075 jgr1@columbia.edu
Contact:   Martin C McElhiney, Ph.D. 646.774.8035 mcelhin@nyspi.columbia.edu

Locations

United States, New York
Callen-Lorde Community Health Center Recruiting
New York, New York, United States, 10011
Contact: Anita Radix, M.D.    212-271-7200    aradix@callen-lorde.org
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Judith G. Rabkin, Ph.D., MPH    646-774-8075    jgr1@columbia.edu
Contact: Martin McElhiney, Ph.D.    646.774.8035    Mcelhin@nyspi.columbia.edu
Principal Investigator: Judith G. Rabkin, PhD, MPH

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
More Information

More Information


Responsible Party: New York State Psychiatric Institute  
ClinicalTrials.gov Identifier: NCT02140775   History of Changes  
Other Study ID Numbers: 6911  
Study First Received: April 18, 2014  
Last Updated: December 20, 2016  

Keywords provided by New York State Psychiatric Institute:

HIV
AIDS
Fatigue
armodafinil
Unemployment

Additional relevant MeSH terms:
HIV Infections
Fatigue

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.