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CID 0911 - Adaptation of A Depression Treatment Intervention for HIV Patients in Cameroon (ADEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02156622
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bradley N. Gaynes, MD, MPH, University of North Carolina, Chapel Hill

Brief Summary:

The purpose of this study is to adapt depression treatment intervention for HIV patients in Cameroon. The PI will validate a depression severity measure, adapt key elements of the intervention to the Cameroon context, train nurses and physicians to carry out the intervention, and examine preliminary outcomes.

Participants: Aim 1: Hospital and clinic patients, visitors, health care workers. Aim 2: No participants. Aim 3: HIV-infected patients. Procedures (methods): Survey instruments and ARV treatment.


Condition or disease
HIV Major Depressive Disorder

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Study Type : Observational [Patient Registry]
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CID 0911 - Adaptation of A Depression Treatment Intervention for HIV Patients in Cameroon
Study Start Date : July 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Depression Care Manager
All enrolled in AIM 3 received decision support from Depression Care Manager



Primary Outcome Measures :
  1. Mean CD4 count [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Remission of depression [ Time Frame: 4 months ]
    Remission defined as PHQ-9 score < 5


Biospecimen Retention:   Samples Without DNA
Assessed CD4 counts and viral loads


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected patients attending the Bamenda Regional Hospital AIDS Treatment Center
Criteria

Inclusion Criteria:

  • a score ≥ 10 on the PHQ-9 (Patient Health Questionnaire-9 item version)
  • current major depressive disorder confirmed through clinical assessment
  • 18-65 years of age
  • competent in English.

Exclusion Criteria:

  • current acute, high-risk suicidality
  • history of bipolar disorder or psychotic disorder as determined through clinical assessment
  • current substance abuse problem that in the judgment of the clinician would need to be addressed prior to depression treatment.

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): NCT02156622


Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Bradley N Gaynes, MD UNC-Chapel Hill
Additional Information:

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Responsible Party: Bradley N. Gaynes, MD, MPH, Professor of Psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02156622    
Other Study ID Numbers: 09-0852
5R34MH084673-02 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014
Keywords provided by Bradley N. Gaynes, MD, MPH, University of North Carolina, Chapel Hill:
HIV
Depression
Measurement-based care
Outcomes
Viral load
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders