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Trial record 6 of 48 for:    "Depressive Disorder" [DISEASE] | ( Map: Vermont, United States )

Re-Engineering Systems for the Primary Care Treatment for PTSD (RESPECT-PTSD)

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ClinicalTrials.gov Identifier: NCT00373698
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : November 7, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stress Disorders, Posttraumatic
Depression
Intervention Behavioral: Three Component Model of Collaborative Care
Enrollment 195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Three Component Model of Collaborative Care and Usual Care Usual Care
Hide Arm/Group Description Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's "Usual Care" is at the VA provider's discretion and could include referral to mental health specialty care.specialty care. Participants randomized to "Usual Care" received care at the VA provider's discretion and could include referral to mental health specialty care.
Period Title: Overall Study
Started 96 99
Completed 85 99
Not Completed 11 0
Arm/Group Title Three Component Model Usual Care Total
Hide Arm/Group Description Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. Patients randomized to "Usual Care" will receive care as usual by VA clinicians. Total of all reporting groups
Overall Number of Baseline Participants 96 99 195
Hide Baseline Analysis Population Description
To be included, subjects had to meet diagnostic criteria for PTSD, have regular access to a telephone, and speak English. Exclusion criteria were cognitive impairment, history of psychosis or mania, prominent current suicidal ideation, current substance dependence, and current engagement in mental health treatment
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age, >=18 Number Analyzed 96 participants 99 participants 195 participants
46.1 [1] 
(NA to NA)
44.4 [2] 
(NA to NA)
NA [3] 
(NA to NA)
[1]
43.1-49.1 (95% confidence interval)
[2]
41.3-47.5 (95% confidence interval)
[3]
The data are locked and the total can not be calculated.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 99 participants 195 participants
Female
7
   7.3%
10
  10.1%
17
   8.7%
Male
89
  92.7%
89
  89.9%
178
  91.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 96 participants 99 participants 195 participants
96 99 195
PTSD symptom severity (used Posttraumatic Diagnostic Scale (PDS))   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 96 participants 99 participants 195 participants
33.2  (8.3) 34.0  (9.7) NA [2]   (NA)
[1]
Measure Description: The PDS yields a total severity score (ranging from 0 to 51, where 0 is the best and 51 is the worst) that largely reflects the frequency of the 17 symptoms of PTSD. 17 symptoms of PTSD are rated individually on a scale from 0 to 3, with 3 being the highest. Total severity score is calculated by adding the number from each individual symptom. A PDS Profile Report also provides a preliminary determination of DSM-IV PTSD diagnostic status, a count of the number of symptoms endorsed, a rating of symptom severity, and a rating of the level of impairment of functioning.
[2]
The data are locked and can not be calculated
Depression (Hopkins Symptom Checklist-20)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 96 participants 99 participants 195 participants
1.98  (0.69) 2.06  (0.78) NA [2]   (NA)
[1]
Measure Description: Depression severity (ranging 0-4) was measured with the Hopkins Symptom Checklist-20. This self-assessment measure consists of 20 questions with possible scores ranging from 0 to 4, with higher scores indicating worse symptoms. Means and the standard deviations of the 20 questions are presented with higher scores indicating worse depression.
[2]
The data are locked and can not be calculated
SF-36 Mental Component   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 96 participants 99 participants 195 participants
33.8  (8.8) 32.7  (8.1) NA [2]   (NA)
[1]
Measure Description: SF-36 Mental Component is measured as part of SF-36 Health Survey. Scores can range from 0 (poorest possible health ) to 100 (highest possible health).
[2]
The data are locked and can not be calculated.
SF-36 Physical Component   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 96 participants 99 participants 195 participants
42.2  (13.0) 43.4  (12.6) NA [2]   (NA)
[1]
Measure Description: SF-36 Physical Component is measured as part of SF-36 Health Survey. Scores can range from 0 (poorest possible health ) to 100 (highest possible health).
[2]
The data are locked and can not be calculated.
1.Primary Outcome
Title PTSD Symptom Severity
Hide Description PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Time Frame 3 and 6 months after initial assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm1/Three Component Model of Care Collaborative Care Arm 2/Usual Care
Hide Arm/Group Description:
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Overall Number of Participants Analyzed 96 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
3 months after initial assessment 31.4  (10.2) 31.5  (10.3)
6 months after initial assessment 30.2  (10.3) 29.9  (10.8)
2.Secondary Outcome
Title Depression
Hide Description Measure using the Hopkins Symptom Checklist-20
Time Frame 3 and 6 months after initial assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm1/Three Component Model of Care Collaborative Care Arm 2/Usual Care
Hide Arm/Group Description:
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Overall Number of Participants Analyzed 96 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
3 months after initial assessment 1.8  (0.8) 1.84  (0.82)
6 months after initial assessment 1.81  (0.84) 1.83  (0.90)
3.Secondary Outcome
Title SF-36 Mental Component
Hide Description [Not Specified]
Time Frame 3 and 6 months after initial assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm1/Three Component Model of Care Collaborative Care Arm 2/Usual Care
Hide Arm/Group Description:
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Overall Number of Participants Analyzed 96 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component-3 months after initial assessment 33.9  (8.3) 33.8  (8.1)
Mental Component-6 months after initial assessment 33.7  (9.4) 33.4  (8.1)
4.Secondary Outcome
Title SF-36 Physical Component
Hide Description [Not Specified]
Time Frame 3 and 6 months after initial assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Three Component Model Usual Care
Hide Arm/Group Description:
Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Overall Number of Participants Analyzed 96 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component-3 months after initial assessme 43.8  (13.1) 43.7  (12.2)
Physical Component-6 monthsafter initial assessmen 44.4  (12.6) 44.8  (11.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Three Component Model Usual Care
Hide Arm/Group Description Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
All-Cause Mortality
Three Component Model Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Three Component Model Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   5/96 (5.21%)   4/99 (4.04%) 
Surgical and medical procedures     
hospitalization *  5/96 (5.21%)  4/99 (4.04%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Three Component Model Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   0/99 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paula Schnurr and Dr. Mathew Friedman
Organization: VA Medical Center, White River Junction, VT
Phone: 802-296-5132
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00373698     History of Changes
Other Study ID Numbers: IAC 06-073
First Submitted: September 6, 2006
First Posted: September 8, 2006
Results First Submitted: July 31, 2014
Results First Posted: November 7, 2014
Last Update Posted: April 24, 2015