DepressionNCT02309372
Depression Therapy to Improve Cardiovascular Risk in HIV
A study testing Beating the Blues in people with Depression and HIV, run by Indiana University at 2 sites in United States.
Trial summary
This trial will determine if depression treatment will reduce cardiovascular risk in HIV-infected patients already receiving HIV treatments. Half of the participants will undergo a specific computerized depression treatment with the other half receiving usual care from their HIV providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, HIV
- What is being tested?
- Beating the Blues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load
- Age equal to or greater than 18 years
- Receipt of antiretroviral therapy of any kind for at least 360 days prior to screening
- Note: Interruptions in ART of up to 14 days total during the 360 days prior to screening are allowed
- HIV-1 RNA level < 75 copies/mL at screening
- NOTE: There are no CD4 cell count eligibility criteria for this trial
- For women who are still of reproductive potential, a negative urine pregnancy test
- Depression as defined by having a score ≥ 10 on the PHQ-9 questionnaire
Who cannot join
- Inability to complete written, informed consent
- Incarceration at the time of any study visit
- Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions on the Patient Suicidality Form (with last suicide attempt within the past ten years)
- Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
- History of congestive heart failure, even if currently compensated
- Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases)
Show all 24Show fewer
- Note: Hepatitis B or C co-infections are NOT exclusionary
- Known or suspected malignancy requiring systemic treatment within 180 days of screening
- NOTE: Localized treatment for skin cancers is not exclusionary
- History of Raynaud's phenomenon
- History of cardiac arrhythmias or cardiomyopathy
- Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment
- History of carotid bruits
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg at screening
- Screening estimated glomerular filtration rate (eGFR) < 50 mL/min/1.732 (using the 2009 CKD-EPI equation) using a serum creatinine level measured at screening
- Screening glucose ≥ 140 mg/dL or hemoglobin A1c > 8.0%
- Screening total cholesterol > 240 mg/dL
- Therapy for serious medical illnesses within 14 days prior to screening
- Note: Therapy for serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation
- Pregnancy or breastfeeding during the course of the study
- Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at screening
- Note: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors
- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- History of schizophrenia or bipolar disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health University Hospital, Indiana Clinical Research Center
Indianapolis, Indiana, 46202
Infectious Diseases Research Center
Indianapolis, Indiana, 46202
About this study
Official title: A Randomized, Controlled Pilot Trial Assessing the Utility of Cognitive Behavioral Therapy to Improve Endothelial Function and Reduce Inflammation in Depressed, Virologically-Suppressed, Antiretroviral-Treated, HIV-infected Adults
This trial will determine if depression treatment will reduce cardiovascular risk in HIV-infected patients already receiving HIV treatments. Half of the participants will undergo a specific computerized depression treatment with the other half receiving usual care from their HIV providers.
Read the detailed description
The objectives of this study will be met by performing a 24-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center. A total of 200 subjects may be screened to identify 110 participants to be enrolled and randomized. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy for at least one year with an HIV viral load < 75 copies/mL at screening, and have major depression using the PHQ-9 questionnaire. These participants will be randomized 1:1 to either depression treatment with the Beating-the-Blues cognitive behavioral therapy program (N=55) or usual care (N=55).
- Conditions
- Depression, HIV
- Being tested
- Beating the Blues
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beating the BluesBehavioural
Computerized depression treatment intervention
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention. Receives: Behavioral: Beating the Blues |
| Usual Care | No intervention | No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
Changes in flow-mediated dilation of the brachial artery from baseline to week 12. This is calculated by the FMD value at Week 12 minus the FMD value at baseline.
Measured: Baseline and Week 12 of participation
Secondary outcomes (3)
Changes in Circulating IL-6 From Baseline to Week 12
Interleukin-6 (IL-6) is a measure of systemic inflammation. This is calculated by the IL-6 value at Week 12 minus the IL-6 value at baseline.
Measured: Baseline and 12 weeks
Change in hsCRP From Baseline to Week 12
hsCRP (high sensitivity C-reactive protein) is a measure of systemic inflammation. This is calculated by the hsCRP value at Week 12 minus the hsCRP value at baseline.
Measured: 12 weeks
Change in D-dimer From Baseline to Week 12
D-dimer is a measure of systemic coagulation. This is calculated by the D-dimer value at Week 12 minus the D-dimer value at baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionApr 2019
- Study completionApr 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 DepressionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir K Gupta, MD, MS, Indiana University
- Investigators
- Samir K Gupta, MD, Principal investigator, Indiana UniversityJesse C Stewart, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309372
- Sponsor's protocol ID
- R01HL126557
- Status last verified
- Jul 2020
- First submitted
- 3 Dec 2014
- Last updated
- 14 Jul 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Pilot Trial Assessing the Utility of Cognitive Behavioral Therapy to Improve Endothelial Function and Reduce Inflammation in Depressed, Virologically-Suppressed, Antiretroviral-Treated, HIV-infected Adults
- ClinicalTrials.gov ID
- NCT02309372
- Acronym / sponsor ID
- R01HL126557
- Conditions
- Depression, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will determine if depression treatment will reduce cardiovascular risk in HIV-infected patients already receiving HIV treatments. Half of the participants will undergo a specific computerized depression treatment with the other half receiving usual care from their HIV providers.
Detailed description
The objectives of this study will be met by performing a 24-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center. A total of 200 subjects may be screened to identify 110 participants to be enrolled and randomized. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy for at least one year with an HIV viral load < 75 copies/mL at screening, and have major depression using the PHQ-9 questionnaire. These participants will be randomized 1:1 to either depression treatment with the Beating-the-Blues cognitive behavioral therapy program (N=55) or usual care (N=55).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Beating the BluesThose assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention. |
| Usual Care | No intervention | –No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load
- Age equal to or greater than 18 years
- Receipt of antiretroviral therapy of any kind for at least 360 days prior to screening
- Note: Interruptions in ART of up to 14 days total during the 360 days prior to screening are allowed
- HIV-1 RNA level < 75 copies/mL at screening
Key exclusion criteria (24 listed)
- Inability to complete written, informed consent
- Incarceration at the time of any study visit
- Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions on the Patient Suicidality Form (with last suicide attempt within the past ten years)
- Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
- History of congestive heart failure, even if currently compensated
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 |
|---|---|---|
| Beating the BluesComputerized depression treatment intervention | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
Time frame: Baseline and Week 12 of participation
Changes in flow-mediated dilation of the brachial artery from baseline to week 12. This is calculated by the FMD value at Week 12 minus the FMD value at baseline.
3 secondary outcomes
Changes in Circulating IL-6 From Baseline to Week 12
Time frame: Baseline and 12 weeks
Change in hsCRP From Baseline to Week 12
Time frame: 12 weeks
Change in D-dimer From Baseline to Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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.
Samir K Gupta, MD principal investigator
Indiana University
Jesse C Stewart, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beating the Blues in people with Depression and HIV, run by Indiana University 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 8 inclusion and 24 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 14 Jul 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 14 Jul 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?
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12 (time frame: Baseline and Week 12 of participation). 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 14 Jul 2020.