Improving the Treatment of Depression Among Youth With HIV

ConditionsDepression Disorders HIV (Human Immunodeficiency Virus)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15-24

SponsorRhode Island Hospital

About this trial

Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness.

This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 15- 24 years

engaged in care at a participating HIV care site

have documented HIV-1 confirmed by medical records

a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment [either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

Disqualifiers

by site review, have a history of any psychotic disorders and/or Bipolar I or II Disorder

have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment

have depression and/or suicidal ideation requiring more intensive services

intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist)

Trial design

Design model

Parallel

Treatments tested in this trial

COMBEX
Behavioral
The intervention (COMBEX) is a combined approach to routine psychotherapy (including CBT and medication management) with additional ERIC strategies incorporated.
COMB
Behavioral
COMB is a combined approach to routine psychotherapy (including CBT and medication management).

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: COMBEXExperimental treatment 1 intervention

Group B: COMBActive comparator 1 intervention

Trial outcomes

Primary outcomes

Patient Health Questionnaire-9 (PHQ-9)

Self-reported depression symptoms score

Time frame

Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72

Secondary outcomes

HIV viral load

Quantitative VL levels (copies/mL) will be abstracted from the medical records

Time frame

Measured at baseline and Weeks 12, 24, 36, 48, 60, and 72

Other outcomes

General Quality of Life

Self-reported score on PROMIS Global Measure

Time frame

Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72

Antidepressant prescription

Prescription of any antidepressant in past 3 months from medical record abstraction

Time frame

Assessed at Weeks 12, 24, 36, 48, 60, and 72

ART Prescription

Prescription of ART in past 3 months from medical record abstraction

Time frame

Assessed at Weeks 12, 24, 36, 48, 60, and 72

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhode Island Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: