Telephone Based Cognitive Behavioral Therapy for HIV Related Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Collaborator:	University of Maryland
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT01055158

Purpose

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.

Condition	Intervention	Phase
Depression HIV Infections	Behavioral: Telephone-based CBT Behavioral: Enhanced Usual Care	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Connect: A Pilot Study of Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Depression HIV/AIDS Mental Health

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Hamilton Depression Scale (HAM-D) [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Provision of Social Relationships (PSR) [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]
Brief COPE [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]
SF-12 Health Survey [ Time Frame: Baseline, Week 8, Week 16 ] [ Designated as safety issue: No ]
Therapist Adherence [ Time Frame: Week 1-14 ] [ Designated as safety issue: No ]
Participant Adherence to Treatment [ Time Frame: Week 1-14 ] [ Designated as safety issue: No ]
Working Alliance Inventory [ Time Frame: Week 8, Week 16 ] [ Designated as safety issue: No ]
Satisfaction Index- Mental Health (SIMH-PW) [ Time Frame: Week 8, Week 16 ] [ Designated as safety issue: No ]
Expectancy Scales [ Time Frame: Week 8, Week 16 ] [ Designated as safety issue: No ]
HIV Viral Load and CD4 Count [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
Adherence to Highly Active Antiretroviral Therapy (HAART) [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2010
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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.

Arms

Assigned Interventions

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 Name: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055158

Locations

United States, Maryland
University of Maryland Medical Center, Evelyn Jordan Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Seth S Himelhoch, MD, MPH 410-706-2490 shimelho@psych.umaryland.edu
Contact: Charles T Robinson, MD (410) 328-1271 crobinso@psych.umaryland.edu
Principal Investigator: Seth S Himelhoch, MD, MPH

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

University of Maryland

Investigators

Principal Investigator:

Seth S Himelhoch, M.D. , M.P.H

University of Maryland

More Information

No publications provided

Responsible Party:	Seth Himelhoch, M.D., M.P.H, Associate Professor of Psychiatry, University of Maryland School of Medicine
ClinicalTrials.gov Identifier:	NCT01055158 History of Changes
Other Study ID Numbers:	1 R34 MH080630
Study First Received:	January 22, 2010
Last Updated:	February 16, 2010
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Institute of Mental Health (NIMH):

HIV

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012