HIV Translating Initiatives for Depression Into Effective Solutions (HI-TIDES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00304915
First received: March 16, 2006
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.


Condition Intervention
HIV
Depression
Behavioral: Collaborative Care Interventions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIV Translating Initiatives for Depression Into Effective Solutions

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Implementation Process, Quality of Care, Depression Severity [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Related Quality of Life, Medication Adherence, Treatment Satisfaction, Cost Effectiveness [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: February 2007
Estimated Study Completion Date: November 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Depressed HIV patients
Behavioral: Collaborative Care Interventions
Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.

Detailed Description:

Background: Depression is the most common mental disorder in HIV infected patients. Despite the availability of efficacious treatments for depression, evidence suggests that it is under-diagnosed and under-treated in routine HIV care. To address this problem, we will adapt and implement a collaborative stepped-care model for depression treatment in HIV clinics. This proposal builds on past success of the TIDES/WAVES and RETIDES programs used in VA primary care. The proposed SDP (HI-TIDES or HIV Translating Initiatives for Depression into Effective Solutions) will implement the primary care collaborative care model for depression treatment in HIV clinics using evidence-based implementation strategies. Objectives: The objectives of this proposal are to: 1) Develop and evaluate the process of adapting, implementing, and sustaining collaborative care for depression in VA HIV clinics, 2) Compare the quality of depression care and the clinical effectiveness of HI-TIDES to usual care in the HIV clinics, and 3) Evaluate the cost-effectiveness of patients assigned to HI-TIDES relative to patients assigned to usual care in HIV clinics. Methods: The implementation framework for this proposal is primarily informed by the Rogers diffusion of innovation model, Simpson Transfer Model, and the PRECEDE model. The VA and American Psychiatric Association Practice Guidelines inform the stepped care collaborative model intervention as source documents for summarizing the evidence for depression treatment for the general population. An expert panel will be convened to rate the quality of available evidence for depression treatment in the context of HIV. Patients will be recruited from VA HIV clinics: Little Rock, Atlanta, and Houston. The intervention will be randomized at the level of the patient. We expect to recruit a total of 140 intervention and 140 usual care patients. Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager. A formative evaluation will occur during start-up and throughout the implementation of the intervention. A summative evaluation will document the effectiveness and cost-effectiveness of the intervention using an intent to treat analysis plan. Findings: No results at this time. Status: Start-up activities. Impact: The proposed study is highly relevant to the VA and the veterans it serves for many reasons. First, the majority of VA patients with HIV are not seen in the primary care clinics and therefore will not benefit from VHA's efforts in primary care settings to improve depression identification and treatment. Second, in addition to the negative outcomes of depression generally, depression in HIV patients is associated with additional negative outcomes including accelerated HIV disease progression, decreased immune system functioning, and premature death. Third, directly moving collaborative depression care from primary care clinics to HIV clinics is likely to fail for several reasons including the comorbidities associated with depressed HIV patient and the potential for drug-drug interactions. The proposed project will address these gaps and provide effectiveness and cost-effectiveness analyses to inform decisions about larger scale implementation of the HI-TIDES intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. current PHQ-9 score of 10 or more and
  2. current treatment in the HIV clinic.

Exclusion Criteria:

  1. patients who do not have access to a telephone,
  2. patients with current suicidal ideation,
  3. patients with significant cognitive impairment as indicated by a score < 10 on the HIV Dementia Scale, and
  4. patients with a chart diagnosis of schizophrenia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304915

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System (North Little Rock)
No. Little Rock, Arkansas, United States, 72114-1706
United States, Georgia
VA Medical Center, Decatur
Decatur, Georgia, United States, 30033
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey M. Pyne, MD Central Arkansas Veterans Healthcare System (North Little Rock)
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00304915     History of Changes
Other Study ID Numbers: MNT 05-152
Study First Received: March 16, 2006
Last Updated: August 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Collaborative

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014