Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

Connect: A Pilot Study of Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; HIV Infections
• Intervention / Treatment: Behavioral: Telephone-based CBT; Behavioral: Enhanced Usual Care

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center, Evelyn Jordan Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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. All sessions begin with a depression rating and agenda setting and end with task assignments and summaries.; Other Names: CONNECT
Active Comparator: Control; Enhanced Usual Care	Behavioral: Enhanced Usual Care; Participants randomized to this condition will be referred to receive in-person psychotherapy. Research study staff will help participants to set up their first appointment with a psychotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute of Mental Health (NIMH); University of Maryland, College Park
• Investigators: Principal Investigator: Seth S Himelhoch, M.D., M.P.H, University of Maryland, College Park

Publications and helpful links

General Publications

• Himelhoch S, Medoff D, Maxfield J, Dihmes S, Dixon L, Robinson C, Potts W, Mohr DC. Telephone based cognitive behavioral therapy targeting major depression among urban dwelling, low income people living with HIV/AIDS: results of a randomized controlled trial. AIDS Behav. 2013 Oct;17(8):2756-64. doi: 10.1007/s10461-013-0465-5.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 22, 2010
• First Submitted That Met QC Criteria: January 22, 2010
• First Posted (Estimate): January 25, 2010

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: HP-00043648; R34MH080630 (U.S. NIH Grant/Contract)