Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703

Depression HIV-1-infection Inflammation

RECRUITING NA

Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users

NCT00183768

HIV Infections Depression Substance-Related Disorders

COMPLETED PHASE3

Improving the Treatment of Depression Among Youth With HIV

NCT07211087

Depression Disorders HIV (Human Immunodeficiency Virus)

NOT_YET_RECRUITING NA

IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV

NCT02939131

HIV Depression

COMPLETED NA

Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea

NCT03823261

HIV Infections

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people.

Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months.

Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Depression HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enhanced treatment as usual

Participants will receive the life-steps intervention and treatment as usual.

Group Type ACTIVE_COMPARATOR

Life-steps adherence treatment

Intervention Type BEHAVIORAL

Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management

CBT for adherence and depression (CBT-AD)

Participants will receive the life-steps and CBT-AD interventions.

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)

Intervention Type BEHAVIORAL

12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications

Life-steps adherence treatment

Intervention Type BEHAVIORAL

Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management

ISP for adherence and depression (ISP-AD)

Participants will receive the life-steps and ISP-AD interventions.

Group Type ACTIVE_COMPARATOR

Life-steps adherence treatment

Intervention Type BEHAVIORAL

Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management

Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)

Intervention Type BEHAVIORAL

12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)

12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications

Intervention Type BEHAVIORAL

Life-steps adherence treatment

Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management

Intervention Type BEHAVIORAL

Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)

12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV-infected
* Current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions \[CGI\] scale score of 2 or greater)
* Prescribed a stable regimen of highly active antiretroviral therapy (HAART) for HIV for at least 2 months

Exclusion Criteria

* Active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (CBT) treatment for depression
* Diagnosis with any primary psychotic disorder, even if treated
* Treatment with CBT within the past year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No