DepressionPhase 2NCT04286282
Neuroinflammation and Modulating Factors in Depression and HIV
A Phase 2 study testing Group Pyschotherapy in people with Depression and HIV, run by University of Minnesota at 1 site in Uganda.
Trial summary
Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, HIV
- What is being tested?
- Group Pyschotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUganda
- Study dates
- 1 Feb 2021to 9 Apr 2024
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the depressed patient arm,
- Newly-presenting clinic patients (<3 months)
- Mild to Moderately-Severe Depressive Symptoms with PHQ-9 score >5 but <20
- Not suicidal (PHQ-9 question 9 score >2)
- Not receiving antiretroviral therapy (ART) at screening
- Outpatient, not requiring hospitalization
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- For the non-depressed patient arm,
- Newly-presenting clinic patients (<3 months)
- Not suicidal (PHQ-9 question 9 score >2)
- Not receiving antiretroviral therapy (ART) at screening
- Outpatient, not requiring hospitalization
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda
Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.
Read the detailed description
Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood.
- Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy.
- In the same population determine if persistent depression is associated with higher levels of innate inflammation. Also, compare baseline and follow up inflammation among depressed compared to non-depressed control group.
- Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.
- Conditions
- Depression, HIV
- Being tested
- Group Pyschotherapy, Depression Standard of Care, HIV Standard of Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PyschotherapyBehavioural
Group psychotherapy
Depression Standard of CareOther
Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
HIV Standard of CareOther
Standard clinical care for HIV
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | The first 100 participants with HIV and depression will receive standard of care including SSRI therapy. Receives: Other: Depression Standard of Care; Other: HIV Standard of Care |
| Standard of Care + Group Support Psychotherapy | Experimental | The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. Receives: Behavioral: Group Pyschotherapy; Other: Depression Standard of Care; Other: HIV Standard of Care |
| Standard of Care (Non-Depressed) | Active comparator | 100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment. Receives: Other: HIV Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity.
a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression.
change between baseline and 3 months
Measured: 3 months
Change in Patient Health Questionnaire (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity.
a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression.
change between baseline and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Feb 2021
- Primary completion9 Nov 2023
- Study completion9 Apr 2024
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 University of MinnesotaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Lofgren, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286282
- Sponsor's protocol ID
- STUDY00006374
- Other IDs
- K23MH121220
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2020
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda
- ClinicalTrials.gov ID
- NCT04286282
- Acronym / sponsor ID
- STUDY00006374
- Conditions
- Depression, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.
Detailed description
Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood.
- Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy.
- In the same population determine if persistent depression is associated with higher levels of innate inflammation. Also, compare baseline and follow up inflammation among depressed compared to non-depressed control group.
- Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Depression Standard of Care, Other: HIV Standard of CareThe first 100 participants with HIV and depression will receive standard of care including SSRI therapy. |
| Standard of Care + Group Support Psychotherapy | Experimental | Behavioral: Group Pyschotherapy, Other: Depression Standard of Care, Other: HIV Standard of CareThe second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. |
| Standard of Care (Non-Depressed) | Active comparator | Other: HIV Standard of Care100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For the depressed patient arm,
- Newly-presenting clinic patients (<3 months)
- Mild to Moderately-Severe Depressive Symptoms with PHQ-9 score >5 but <20
- Not suicidal (PHQ-9 question 9 score >2)
- Not receiving antiretroviral therapy (ART) at screening
Key exclusion criteria (1 listed)
- No additional exclusion criteria
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 |
|---|---|---|
| Group PyschotherapyGroup psychotherapy | Behavioural | Standard of Care + Group Support Psychotherapy |
| Depression Standard of CareStandard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). | Other | Standard of Care, Standard of Care + Group Support Psychotherapy |
| HIV Standard of CareStandard clinical care for HIV | Other | Standard of Care, Standard of Care (Non-Depressed), Standard of Care + Group Support Psychotherapy |
Primary outcome
Change in Patient Health Questionnaire (PHQ)-9
Time frame: 3 months
The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 3 months
Change in Patient Health Questionnaire (PHQ)-9
Time frame: 6 months
The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- 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.
Sarah Lofgren, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group Pyschotherapy in people with Depression and HIV, run by University of Minnesota at 1 site in Uganda.
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 11 inclusion and 1 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). 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 Patient Health Questionnaire (PHQ)-9 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 9 Jan 2025.