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Trial record 1 of 1 for:    30516797 [PUBMED-IDS]
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PROlonGed ExpoSure Sertraline (PROGrESS)

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ClinicalTrials.gov Identifier: NCT01524133
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Sheila Rauch, Atlanta VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Interventions Drug: Sertraline
Behavioral: Prolonged Exposure Therapy
Enrollment 223
Recruitment Details  
Pre-assignment Details Patients were informed of assignment at first treatment visit. Only those randomized patients who started treatment are included below (16 patients never started treatment. They did not know condition assignment.).
Arm/Group Title Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Hide Arm/Group Description

24 weeks of sertraline + enhanced medication management

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Period Title: Treatment Phase
Started 71 69 67
Completed 52 [1] 37 [2] 31 [2]
Not Completed 19 32 36
Reason Not Completed
Withdrawal by Subject             13             28             31
Physician Decision             6             3             3
Lost to Follow-up             0             1             2
[1]
Completed Both Assigned treatment
[2]
Completed Both Assigned Treatments
Period Title: Overall Study 52 Weeks
Started [1] 71 69 67
Completed 50 49 40
Not Completed 21 20 27
Reason Not Completed
Withdrawal by Subject             4             5             10
Physician Decision             1             0             2
Lost to Follow-up             16             15             15
[1]
Treatment occurred weeks 0-24 and naturalistic follow-up continued through to week 52.
Arm/Group Title Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB) Total
Hide Arm/Group Description

24 weeks of sertraline + enhanced medication management

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Total of all reporting groups
Overall Number of Baseline Participants 71 69 67 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 69 participants 67 participants 207 participants
33.7  (8.2) 35.1  (8.5) 34.7  (8.3) 34.5  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 69 participants 67 participants 207 participants
Female
5
   7.0%
14
  20.3%
8
  11.9%
27
  13.0%
Male
66
  93.0%
55
  79.7%
59
  88.1%
180
  87.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 69 participants 67 participants 207 participants
Hispanic or Latino
14
  19.7%
10
  14.5%
7
  10.4%
31
  15.0%
Not Hispanic or Latino
57
  80.3%
59
  85.5%
60
  89.6%
176
  85.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 71 participants 69 participants 67 participants 207 participants
White
43
  60.6%
40
  58.0%
36
  53.7%
119
  57.5%
African American
20
  28.2%
22
  31.9%
20
  29.9%
62
  30.0%
Other
8
  11.3%
7
  10.1%
11
  16.4%
26
  12.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 71 participants 69 participants 67 participants 207 participants
71
 100.0%
69
 100.0%
67
 100.0%
207
 100.0%
1.Primary Outcome
Title Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Hide Description Total Score; Range 0-136 with increasing PTSD severity as scores increase
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received treatment
Arm/Group Title Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Hide Arm/Group Description:

24 weeks of sertraline + enhanced medication management

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Overall Number of Participants Analyzed 71 69 67
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
41.7  (25.7) 43.3  (27.2) 51.5  (25.3)
2.Secondary Outcome
Title Patient Health Questionnaire-15
Hide Description PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized patients who received treatment and had the measure
Arm/Group Title Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Hide Arm/Group Description:

24 weeks of sertraline + enhanced medication management

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Overall Number of Participants Analyzed 71 69 67
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
8.6  (5.7) 9.8  (5.7) 10.5  (5.1)
Time Frame 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Adverse Event Reporting Description Individual descriptions were summarized to organ class
 
Arm/Group Title Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Hide Arm/Group Description

24 weeks of sertraline + enhanced medication management

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline

Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo

Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure

All-Cause Mortality
Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)      0/69 (0.00%)      0/67 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/71 (0.00%)      5/69 (7.25%)      3/67 (4.48%)    
Gastrointestinal disorders       
dyspepsia   0/71 (0.00%)  0 1/69 (1.45%)  1 0/67 (0.00%)  0
Psychiatric disorders       
Increased Suicidal Ideation   0/71 (0.00%)  0 3/69 (4.35%)  3 2/67 (2.99%)  2
Increased Depression   0/71 (0.00%)  0 0/69 (0.00%)  0 1/67 (1.49%)  1
Increased Irritability   0/71 (0.00%)  0 1/69 (1.45%)  1 0/67 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sertraline + Enhanced Medication Management (SERT/EMM) Prolonged Exposure + Sertraline (PE/SERT) Prolonged Exposure + Placebo (PE/PLB)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/71 (97.18%)      61/69 (88.41%)      46/67 (68.66%)    
Blood and lymphatic system disorders       
Hematological   1/71 (1.41%)  1 0/69 (0.00%)  0 1/67 (1.49%)  1
Cardiac disorders       
Cardiovascular   2/71 (2.82%)  2 2/69 (2.90%)  2 4/67 (5.97%)  6
Endocrine disorders       
Endocrine   6/71 (8.45%)  7 1/69 (1.45%)  1 0/67 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal   49/71 (69.01%)  94 34/69 (49.28%)  68 20/67 (29.85%)  39
Musculoskeletal and connective tissue disorders       
Muskuloskeletal   6/71 (8.45%)  6 9/69 (13.04%)  9 3/67 (4.48%)  4
Nervous system disorders       
Neurological   27/71 (38.03%)  38 22/69 (31.88%)  29 14/67 (20.90%)  17
Psychiatric disorders       
Psychological   25/71 (35.21%)  40 24/69 (34.78%)  36 15/67 (22.39%)  25
Renal and urinary disorders       
Genitourinary   25/71 (35.21%)  36 17/69 (24.64%)  25 7/67 (10.45%)  7
Respiratory, thoracic and mediastinal disorders       
Respiratory   10/71 (14.08%)  12 10/69 (14.49%)  18 8/67 (11.94%)  10
Skin and subcutaneous tissue disorders       
Dermatological   2/71 (2.82%)  2 1/69 (1.45%)  1 3/67 (4.48%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sheila Rauch
Organization: Atlanta VAMC
Phone: 404-321-6111 ext 3122
Responsible Party: Sheila Rauch, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT01524133     History of Changes
Other Study ID Numbers: PROGrESS
First Submitted: January 27, 2012
First Posted: February 1, 2012
Results First Submitted: December 6, 2017
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018