HIV InfectionNCT02140775
Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
A study testing Behavioral Activation Counseling in people with HIV Infection and Fatigue, run by New York State Psychiatric Institute at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infection, Fatigue
- What is being tested?
- Behavioral Activation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2014to 31 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+, age 18-70, and under the care of a medical provider
- 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)
- Speaks English (reads English at high school level or shows comprehension in Evaluation to Consent procedure).
- Able and willing to give informed consent
- (Fecund Women): Uses barrier method of contraception
- Patient seeks either work or job-related training
Who cannot join
- 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).
- Untreated hypogonadism, hypothyroidism or anemia (labs out of range).
- Unstable medical condition
- Left ventricular hypertrophy; symptomatic mitral valve prolapse (EKG; medical history)
- Started testosterone in past 4 weeks
- Started antidepressant medication in past 6 weeks
Show all 12Show fewer
- Substance abuse/dependence
- Current clinically significant suicidal ideation
- History or current psychosis or bipolar disorder
- Pregnancy or breast feeding
- Untreated insomnia (Score>3 on 3 HAM-D sleep items).
- Currently taking stimulant medication of past non-responder to armodafinil
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Callen-Lorde Community Health Center
New York, New York, 10011
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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:
- Determine if more participants in BA-PEP return to work compared to SC.
- 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;
- 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).
- Conditions
- HIV Infection, Fatigue
- Being tested
- Behavioral Activation Counseling
- Keywords
- HIV, AIDS, Fatigue, armodafinil, Unemployment
- Medical subject headings
- HIV Infections, Fatigue, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation CounselingBehavioural
Also called Behavioral Activation Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Counseling | Experimental | 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. Receives: Behavioral: Behavioral Activation Counseling |
| Supportive Counseling | Active comparator | 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. Receives: Behavioral: Behavioral Activation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved)
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.
Measured: GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)
Secondary outcomes (2)
Environmental Reward Observation Scale (EROS)
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.
Measured: EROS will be measured at Follow-up (3-6 months after the end of counseling)
Behavioral Activation for Depression Scale (BADS)
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.
Measured: BADS will be measured Follow-up (3-6 months after the end of counseling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study start1 Apr 2014
- Primary completion31 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Callen-Lorde Community Health Center
- Responsible party
- Principal investigator, Martin McElhiney, New York State Psychiatric Institute
- Investigators
- Judith G Rabkin, Ph.D., MPH, Principal investigator, Research Scientist VI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140775
- Sponsor's protocol ID
- 6911
- Status last verified
- Mar 2020
- First submitted
- 18 Apr 2014
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
- ClinicalTrials.gov ID
- NCT02140775
- Acronym / sponsor ID
- 6911
- Conditions
- HIV Infection, Fatigue
- Keywords
- HIV, AIDS, Fatigue, armodafinil, Unemployment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Callen-Lorde Community Health Center
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine if more participants in BA-PEP return to work compared to SC.
- 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;
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Counseling | Experimental | Behavioral: Behavioral Activation CounselingBehavioral 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 | Active comparator | Behavioral: Behavioral Activation CounselingSupportive 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV+, age 18-70, and under the care of a medical provider
- 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)
- Speaks English (reads English at high school level or shows comprehension in Evaluation to Consent procedure).
- Able and willing to give informed consent
- (Fecund Women): Uses barrier method of contraception
Key exclusion criteria (12 listed)
- 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).
- Untreated hypogonadism, hypothyroidism or anemia (labs out of range).
- Unstable medical condition
- Left ventricular hypertrophy; symptomatic mitral valve prolapse (EKG; medical history)
- Started testosterone in past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation CounselingAlso: Behavioral Activation TherapyBehavioral 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. | Behavioural | Behavioral Activation Counseling, Supportive Counseling |
Primary outcome
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.
2 secondary outcomes
Environmental Reward Observation Scale (EROS)
Time frame: EROS will be measured at Follow-up (3-6 months after the end of counseling)
Behavioral Activation for Depression Scale (BADS)
Time frame: BADS will be measured Follow-up (3-6 months after the end of counseling)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith G Rabkin, Ph.D., MPH principal investigator
Research Scientist VI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Counseling in people with HIV Infection and Fatigue, run by New York State Psychiatric Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.