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Completed

NCT Number: NCT01055158

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center, Evelyn Jordan Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-based CBT

Behavioral

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

Enhanced Usual Care

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Maryland, College Park

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2010
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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