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HIV Translating Initiatives for Depression Into Effective Solutions

HIV Translating Initiatives for Depression Into Effective Solutions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00304915
Acronym
HI-TIDES
Enrollment
249
Registered
2006-03-20
Start date
2007-02-28
Completion date
2016-11-30
Last updated
2016-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Depression

Keywords

HIV, depression, patient care management, patient care team

Brief summary

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

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, the investigators 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 programs used in VA primary care. The project (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. The investigators 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 the VA electronic medical record. 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 VA'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.

Interventions

BEHAVIORALCollaborative 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. current 9-item Patient Health Questionnaire (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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Depression Treatment Response6 monthsDepression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1: Collaborative Care Intervention
Collaborative Care Intervention: 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.
123
Arm 2: Usual Care
Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
126
Total249

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath45
Overall StudyLost to Follow-up1111
Overall StudyWithdrawal by Subject30

Baseline characteristics

CharacteristicArm 1: Collaborative Care InterventionTotalArm 2: Usual Care
Age, Continuous49.8 years
STANDARD_DEVIATION 8.7
49.8 years
STANDARD_DEVIATION 9.6
49.8 years
STANDARD_DEVIATION 10.5
Gender
Female
3 Participants7 Participants4 Participants
Gender
Male
120 Participants242 Participants122 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
78 Participants155 Participants77 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
45 Participants94 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1230 / 126
serious
Total, serious adverse events
0 / 1230 / 126

Outcome results

Primary

Percentage of Participants With Depression Treatment Response

Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.

Time frame: 6 months

Population: intent to treat analysis

ArmMeasureValue (NUMBER)
Arm 1: Collaborative Care InterventionPercentage of Participants With Depression Treatment Response33.3 percent response
Arm 2: Usual CarePercentage of Participants With Depression Treatment Response17.5 percent response
p-value: 0.00395% CI: [1.37, 4.56]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026