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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

January 22, 2010
October 18, 2012
January 2010
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01055158 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • HIV Infections
  • 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
  • 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.
  • 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.
    Intervention: Behavioral: Telephone-based CBT
  • Active Comparator: Control
    Enhanced Usual Care
    Intervention: Behavioral: Enhanced Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01055158
1 R34 MH080630
No
National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
University of Maryland
Principal Investigator: Seth S Himelhoch, M.D. , M.P.H University of Maryland
National Institute of Mental Health (NIMH)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP