Clinical trial NCT01055158: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
HIV Infections
Keywords: HIV
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Maryland, College Park
First posted: 2010-01-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: Baseline, Week 8, Week 16
measure: The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)
timeFrame: Baseline, Week 8, Week 16
Secondary outcomes:
measure: Provision of Social Relationships (PSR)
timeFrame: Baseline, Week 8, Week 16
measure: Brief COPE
timeFrame: Baseline, Week 8, Week 16
measure: SF-12 Health Survey
timeFrame: Baseline, Week 8, Week 16
measure: Therapist Adherence
timeFrame: Week 1-14
measure: Participant Adherence to Treatment
timeFrame: Week 1-14
measure: Working Alliance Inventory
timeFrame: Week 8, Week 16
measure: Satisfaction Index- Mental Health (SIMH-PW)
timeFrame: Week 8, Week 16
measure: Expectancy Scales
timeFrame: Week 8, Week 16
measure: Adherence to Highly Active Antiretroviral Therapy (HAART)
timeFrame: Baseline, Week 15
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center, Evelyn Jordan Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Seth S Himelhoch, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References:
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.