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

Depression Clinical Trial

Official title:

Efficacy of CBT for Adherence and Depression in HIV Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951028
• Other study ID #: R01MH084757
• Secondary ID: R01MH0847571R01M
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: June 17, 2013
• Start date: September 2008
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV
• HIV Infections

Intervention

Behavioral:
• 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
• 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
• 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.

Locations

Country	Name	City	State
United States	Fenway Community Health Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Butler Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores	HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.	Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months	No
Secondary	changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor		Measured at baseline and after 4, 8, and 12 months	No
Secondary	changes in depression, as measured by the blinded assessor CGI rating		Measured at baseline and after 4, 8, and 12 months	No
Secondary	changes in RNA viral load		Measured at baseline and after 4, 8, and 12 months	No
Secondary	changes in CD4 cell count		Measured at baseline and after 4, 8, and 12 months	No
Secondary	changes in self-reported depression (CESD)	This is measured more frequently during the acute phase (pretreatment to post-treatment) then at the follow up assessments.	Measured at each visit	No