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Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

Primary Purpose

Depression, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-based CBT
Enhanced Usual Care
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Medical Center, Evelyn Jordan Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telephone-based CBT

Control

Arm Description

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.

Enhanced Usual Care

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)

Secondary Outcome Measures

Provision of Social Relationships (PSR)
Brief COPE
SF-12 Health Survey
Therapist Adherence
Participant Adherence to Treatment
Working Alliance Inventory
Satisfaction Index- Mental Health (SIMH-PW)
Expectancy Scales
Adherence to Highly Active Antiretroviral Therapy (HAART)

Full Information

First Posted
January 22, 2010
Last Updated
May 6, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH), University of Maryland, College Park
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1. Study Identification

Unique Protocol Identification Number
NCT01055158
Brief Title
Telephone Based Cognitive Behavioral Therapy for HIV Related Depression
Official Title
Connect: A Pilot Study of Telephone Based Cognitive Behavioral Therapy for HIV Related Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Mental Health (NIMH), University of Maryland, College Park

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, HIV Infections
Keywords
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone-based CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Enhanced Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based CBT
Other Intervention Name(s)
CONNECT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Time Frame
Baseline, Week 8, Week 16
Title
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)
Time Frame
Baseline, Week 8, Week 16
Secondary Outcome Measure Information:
Title
Provision of Social Relationships (PSR)
Time Frame
Baseline, Week 8, Week 16
Title
Brief COPE
Time Frame
Baseline, Week 8, Week 16
Title
SF-12 Health Survey
Time Frame
Baseline, Week 8, Week 16
Title
Therapist Adherence
Time Frame
Week 1-14
Title
Participant Adherence to Treatment
Time Frame
Week 1-14
Title
Working Alliance Inventory
Time Frame
Week 8, Week 16
Title
Satisfaction Index- Mental Health (SIMH-PW)
Time Frame
Week 8, Week 16
Title
Expectancy Scales
Time Frame
Week 8, Week 16
Title
Adherence to Highly Active Antiretroviral Therapy (HAART)
Time Frame
Baseline, Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth S Himelhoch, M.D., M.P.H
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center, Evelyn Jordan Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23644816
Citation
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.
Results Reference
derived

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Telephone Based Cognitive Behavioral Therapy for HIV Related Depression

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