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Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

This study has been completed.
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT01055158
First received: January 22, 2010
Last updated: October 18, 2012
Last verified: January 2010
History of Changes
  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 2

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:

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 ]
  • Adherence to Highly Active Antiretroviral Therapy (HAART) [ Time Frame: Baseline, Week 15 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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.

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
Baltimore, Maryland, United States, 21201
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: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01055158     History of Changes
Other Study ID Numbers: 1 R34 MH080630
Study First Received: January 22, 2010
Last Updated: October 18, 2012
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 March 05, 2013