Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

Not Applicable

Completed

• Conditions: Depression; HIV Infections
• Interventions: Behavioral: Enhanced Usual Care; Behavioral: Telephone-based CBT

• Registration Number: NCT01055158
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV.

Detailed Description

Up to 40% of individuals receiving medical care for HIV meet DSM-IV criteria for co-occurring depressive disorder. Individuals with HIV and depressive disorders, compared to those with HIV alone, have been shown to have worse adherence to taking antiretroviral medication, increased HIV related morbidity and among women a higher mortality. Previous research suggests that mental health interventions may lead to improved depressive and HIV related outcomes. However because many HIV infected depressed individuals may have trouble accessing mental health services, there is an urgent need for treatment trials to assess whether treatment of depression targeting patients in urban HIV care settings will result in both improved depressive and HIV related outcomes. The goal of this project is to test the preliminary effectiveness of an adapted telephone-based, cognitive behavioral therapy (CBT) intervention targeting HIV infected depressed individuals receiving care in adult outpatient HIV clinics. A total of 60 HIV infected, depressed individuals receiving care at an urban, outpatient HIV clinic will be randomly assigned to receive either the telephone psychotherapy intervention or enhanced usual care with non-specific telephone contact. The results will provide preliminary data on whether the telephone psychotherapy intervention for HIV infected depressed individuals is effective in reducing depression. The results will also be used to determine feasibility, accessibility, and whether the intervention leads to improved retention and better satisfaction.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Has a DSM-IV diagnosis of a Depressive Disorder as measured by the mood battery of the MINI
• Has a diagnosis of HIV and is receiving HIV related outpatient care at the Evelyn Jordan Center in Baltimore, MD
• Is able to speak English
• Is able to read English on approximately the 6th grade reading level or higher as measured by the Wide Range Achievement Test 4 (WRAT-4) or by self-report
• Is at least 18 years old
• Has access to a telephone

Exclusion Criteria

• Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale
• Shows signs of serious psychiatric pathology that might either be due to an organic etiology other than HIV, or would generally not be considered treatable solely with psychotherapy, or for whom participation in this protocol might be considered dangerous or unethical
• has a history of serious suicide attempts or is severely suicidal (has ideation, plan, and intent) determined by the MINI
• Patients in psychotherapy are excluded because it is confounded with the study treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Enhanced Usual Care	Enhanced Usual Care
Telephone-based CBT	Telephone-based CBT	A form of CBT delivered over the telephone by a trained, licensed, master's or doctoral level clinician. The intervention consists of approximately 10 sessions conducted over approximately 14 weeks. Each session is approximately 30 to 50 minutes.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAM-D)	Baseline, Week 8, Week 16
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)	Baseline, Week 8, Week 16

Secondary Outcome Measures

Name	Time	Method
Therapist Adherence	Week 1-14
Adherence to Highly Active Antiretroviral Therapy (HAART)	Baseline, Week 15
Provision of Social Relationships (PSR)	Baseline, Week 8, Week 16
SF-12 Health Survey	Baseline, Week 8, Week 16
Brief COPE	Baseline, Week 8, Week 16
Participant Adherence to Treatment	Week 1-14
Working Alliance Inventory	Week 8, Week 16
Expectancy Scales	Week 8, Week 16
Satisfaction Index- Mental Health (SIMH-PW)	Week 8, Week 16

Trial Locations

Locations (1)

University of Maryland Medical Center, Evelyn Jordan Center; 🇺🇸 Baltimore, Maryland, United States