Trial Outcomes & Findings for HIV Translating Initiatives for Depression Into Effective Solutions (NCT NCT00304915)
NCT ID: NCT00304915
Last Updated: 2016-12-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
249 participants
Primary outcome timeframe
6 months
Results posted on
2016-12-29
Participant Flow
Participant milestones
| Measure |
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 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.
|
Arm 2: Usual Care
Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
126
|
|
Overall Study
COMPLETED
|
105
|
110
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
| Measure |
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 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.
|
Arm 2: Usual Care
Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
|
Overall Study
Death
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
HIV Translating Initiatives for Depression Into Effective Solutions
Baseline characteristics by cohort
| Measure |
Arm 1: Collaborative Care Intervention
n=123 Participants
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.
|
Arm 2: Usual Care
n=126 Participants
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.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Gender
Male
|
120 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: intent to treat analysis
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.
Outcome measures
| Measure |
Arm 1: Collaborative Care Intervention
n=123 Participants
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.
|
Arm 2: Usual Care
n=126 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Depression Treatment Response
|
33.3 percent response
|
17.5 percent response
|
Adverse Events
Arm 1: Collaborative Care Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeff Pyne
Central Arkansas Veterans Healthcare System
Phone: 501-257-1083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place