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Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

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ClinicalTrials.gov Identifier: NCT01055158
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression HIV Infections 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Connect: A Pilot Study of Telephone Based Cognitive Behavioral Therapy for HIV Related Depression
Study Start Date : January 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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 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.


Outcome Measures

Primary Outcome Measures :
  1. Hamilton Depression Scale (HAM-D) [ Time Frame: Baseline, Week 8, Week 16 ]
  2. The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) [ Time Frame: Baseline, Week 8, Week 16 ]

Secondary Outcome Measures :
  1. Provision of Social Relationships (PSR) [ Time Frame: Baseline, Week 8, Week 16 ]
  2. Brief COPE [ Time Frame: Baseline, Week 8, Week 16 ]
  3. SF-12 Health Survey [ Time Frame: Baseline, Week 8, Week 16 ]
  4. Therapist Adherence [ Time Frame: Week 1-14 ]
  5. Participant Adherence to Treatment [ Time Frame: Week 1-14 ]
  6. Working Alliance Inventory [ Time Frame: Week 8, Week 16 ]
  7. Satisfaction Index- Mental Health (SIMH-PW) [ Time Frame: Week 8, Week 16 ]
  8. Expectancy Scales [ Time Frame: Week 8, Week 16 ]
  9. Adherence to Highly Active Antiretroviral Therapy (HAART) [ Time Frame: Baseline, Week 15 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055158


Locations
United States, Maryland
University of Maryland Medical Center, Evelyn Jordan Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Seth S Himelhoch, M.D. , M.P.H University of Maryland
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT01055158     History of Changes
Other Study ID Numbers: HP-00043648
R34MH080630 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by University of Maryland:
HIV

Additional relevant MeSH terms:
Depression
Depressive Disorder
HIV Infections
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases