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Trial record 10 of 134 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

Hepatitis C Translating Initiatives for Depression Into Effective Solutions (HEPTIDES)

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ClinicalTrials.gov Identifier: NCT01143896
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : April 11, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Hepatitis C
Depression
Intervention Other: Depression collaborative care model
Enrollment 309
Recruitment Details We recruited a total of 309 patients from CHC clinics at 4 VAs (Houston, St Louis, Little Rock, and Los Angeles) between April 2012 and September 2013. Of these, 292 patients completed baseline interviews. Follow-up data-collection interviews were completed for 263 (90.1%) participants at 6-months and 242 (78.3%) participants at 12-months.
Pre-assignment Details  
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Period Title: Overall Study
Started 156 153
Completed 114 128
Not Completed 42 25
Reason Not Completed
Did not complete Baseline Interview             5             4
Lost to Follow-up             18             13
Withdrawal by Subject             13             5
Death             6             3
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care Total
Hide Arm/Group Description Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition. Total of all reporting groups
Overall Number of Baseline Participants 145 147 292
Hide Baseline Analysis Population Description
A total of 292 participants completed baseline interviews.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 147 participants 292 participants
59  (5.8) 59  (5.2) 59  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 147 participants 292 participants
Female
6
   4.1%
6
   4.1%
12
   4.1%
Male
139
  95.9%
141
  95.9%
280
  95.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 147 participants 292 participants
White Non-Hispanic 59 41 100
Black or African American 72 91 163
Other 14 15 29
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 145 participants 147 participants 292 participants
145 147 292
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 147 participants 292 participants
Single, Never Married 45 68 113
Married 14 16 30
Other (divorced, widowed, separated, no response) 86 63 149
Annual Income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 147 participants 292 participants
Less than $20,000 60 57 117
Over $20,000 43 41 84
Don't Know/Refused 42 49 91
History of Mood Disorders   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 147 participants 292 participants
Yes 65 67 132
No 80 78 158
Don't Know/Refused 0 2 2
[1]
Measure Description: In the last 6 months, did you receive care for personal or emotional problems, feeling down, worried or anxious, or alcohol or drug problem?
Taking antidepressant meds at baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 147 participants 292 participants
Yes 71 67 138
No 71 79 150
Don't Know/Refused 3 1 4
[1]
Measure Description: Do you have a current prescription for any anti-depressant medications, such as prozac or lexapro?
1.Primary Outcome
Title Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment
Hide Description Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description:
Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Overall Number of Participants Analyzed 114 128
Measure Type: Number
Unit of Measure: participants
11 7
2.Primary Outcome
Title Depression Care: Treatment Response
Hide Description Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description:
Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Overall Number of Participants Analyzed 114 128
Measure Type: Number
Unit of Measure: participants
36 19
3.Primary Outcome
Title Depression Care: Depression Remission
Hide Description Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description:
Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Overall Number of Participants Analyzed 114 128
Measure Type: Number
Unit of Measure: participants
22 9
4.Primary Outcome
Title Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months
Hide Description The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.
Time Frame From Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description:
Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Overall Number of Participants Analyzed 114 128
Mean (Standard Deviation)
Unit of Measure: Depression Free Days (DFDs)
118.74  (106.68) 109.30  (117.88)
5.Secondary Outcome
Title Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
Hide Description Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description:
Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Overall Number of Participants Analyzed 114 128
Mean (Standard Deviation)
Unit of Measure: proportion of QIs met
.89  (.16) .83  (.19)
6.Secondary Outcome
Title Medication Adherence: Medication Possession Ratio
Hide Description Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day’s supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description:
Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Overall Number of Participants Analyzed 114 128
Mean (Standard Deviation)
Unit of Measure: medication posession ratio
.83  (.20) .78  (.24)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Depression Collaborative Care Arm 2: Usual Care
Hide Arm/Group Description Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
All-Cause Mortality
Arm 1: Depression Collaborative Care Arm 2: Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Depression Collaborative Care Arm 2: Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/145 (4.14%)      3/147 (2.04%)    
General disorders     
Death (IRB determined unrelated to the study) * [1]  6/145 (4.14%)  6 3/147 (2.04%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Specific cause of death unavailable
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Depression Collaborative Care Arm 2: Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/145 (0.00%)      0/147 (0.00%)    
Primary Outcome Initiation of HCV treatment was affected by the 2012 announcement that new interferon-sparing antiviral drugs might be released within 1 year. Most HCV clinicians advised patients to wait for the new drugs (released in 2014).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Fasiha Kanwal, MD, MSHS
Organization: Michael E. DeBakey VA Medical Center
Phone: (713) 440-4495
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01143896     History of Changes
Other Study ID Numbers: SDP 10-044
10-05 ( Other Identifier: VA Central IRB )
First Submitted: June 11, 2010
First Posted: June 14, 2010
Results First Submitted: January 4, 2016
Results First Posted: April 11, 2016
Last Update Posted: May 16, 2016