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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. Biological mechanisms of change are also examined including emotion processing and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline + enhanced medication management (SERT/EMM) | Active Comparator | 24 weeks of sertraline + enhanced medication management |
|
| Prolonged Exposure + sertraline (PE/SERT) | Active Comparator | Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline |
|
| Prolonged Exposure + placebo (PE/PLB) | Active Comparator | Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | Total Score; Range 0-136 with increasing PTSD severity as scores increase | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-15 | 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 | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila Rauch, PhD | VA Ann Arbor Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States | ||
| Ralph H. Johnson VA Medical Center/Savannah Primary Care Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34147766 | Derived | Allard CB, Norman SB, Straus E, Kim HM, Stein MB, Simon NM, Rauch SAM; PROGrESS Study Team. Reductions in guilt cognitions following prolonged exposure and/or sertraline predict subsequent improvements in PTSD and depression. J Behav Ther Exp Psychiatry. 2021 Dec;73:101666. doi: 10.1016/j.jbtep.2021.101666. Epub 2021 Jun 1. | |
| 34133087 |
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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.).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline + Enhanced Medication Management (SERT/EMM) | 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. |
| FG001 | Prolonged Exposure + Sertraline (PE/SERT) | 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 |
| FG002 | Prolonged Exposure + Placebo (PE/PLB) | Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| |||||||||||||||||||||
| Overall Study 52 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline + Enhanced Medication Management (SERT/EMM) | 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. |
| BG001 | Prolonged Exposure + Sertraline (PE/SERT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | Total Score; Range 0-136 with increasing PTSD severity as scores increase | All randomized patients who received treatment | Posted | Mean | Standard Deviation | Scores on a scale | 24 weeks |
|
52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Individual descriptions were summarized to organ class
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline + Enhanced Medication Management (SERT/EMM) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila Rauch | Atlanta VAMC | 404-321-6111 | 3122 | sheila.rauch@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
| Prolonged Exposure Therapy | Behavioral | up to 13 sessions of prolonged exposure |
|
| Savannah |
| Georgia |
| 31406 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Veterans Affairs Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States |
| Rauch SAM, Kim HM, Lederman S, Sullivan G, Acierno R, Tuerk PW, Simon NM, Venners MR, Norman SB, Allard CB, Porter KE, Martis B, Bui E, Baker AW; PROGrESS Team. Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD. J Clin Psychiatry. 2021 Jun 15;82(4):20m13752. doi: 10.4088/JCP.20m13752. |
| 32668087 | Derived | Sheynin J, Duval ER, King AP, Angstadt M, Phan KL, Simon NM, Rauch SAM, Liberzon I. Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Oct;37(10):1037-1046. doi: 10.1002/da.23075. Epub 2020 Jul 15. |
| 32446108 | Derived | Rauch SAM, King A, Kim HM, Powell C, Rajaram N, Venners M, Simon NM, Hamner M, Liberzon I. Cortisol awakening response in PTSD treatment: Predictor or mechanism of change. Psychoneuroendocrinology. 2020 Aug;118:104714. doi: 10.1016/j.psyneuen.2020.104714. Epub 2020 May 15. |
| 32306485 | Derived | Duval ER, Sheynin J, King AP, Phan KL, Simon NM, Martis B, Porter KE, Norman SB, Liberzon I, Rauch SAM. Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Depress Anxiety. 2020 Jul;37(7):670-681. doi: 10.1002/da.23022. Epub 2020 Apr 19. |
| 32278278 | Derived | Joshi SA, Duval ER, Sheynin J, King AP, Phan KL, Martis B, Porter KE, Liberzon I, Rauch SAM. Neural correlates of emotional reactivity and regulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder. Psychiatry Res Neuroimaging. 2020 May 30;299:111062. doi: 10.1016/j.pscychresns.2020.111062. Epub 2020 Mar 5. |
| 32216142 | Derived | Goetter EM, Hoeppner SS, Khan AJ, Charney ME, Wieman S, Venners MR, Avallone KM, Rauch SAM, Simon NM. Combat-Related Posttraumatic Stress Disorder and Comorbid Major Depression in U.S. Veterans: The Role of Deployment Cycle Adversity and Social Support. J Trauma Stress. 2020 Jun;33(3):276-284. doi: 10.1002/jts.22496. Epub 2020 Mar 26. |
| 30516797 | Derived | Rauch SAM, Kim HM, Powell C, Tuerk PW, Simon NM, Acierno R, Allard CB, Norman SB, Venners MR, Rothbaum BO, Stein MB, Porter K, Martis B, King AP, Liberzon I, Phan KL, Hoge CW. Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Feb 1;76(2):117-126. doi: 10.1001/jamapsychiatry.2018.3412. |
| 29081351 | Derived | Rauch SAM, Simon NM, Kim HM, Acierno R, King AP, Norman SB, Venners MR, Porter K, Phan KL, Tuerk PW, Allard C, Liberzon I, Rothbaum BO, Martis B, Stein MB, Hoge CW. Integrating biological treatment mechanisms into randomized clinical trials: Design of PROGrESS (PROlonGed ExpoSure and Sertraline Trial). Contemp Clin Trials. 2018 Jan;64:128-138. doi: 10.1016/j.cct.2017.10.013. Epub 2017 Oct 29. |
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
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 |
| BG002 | Prolonged Exposure + Placebo (PE/PLB) | Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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
| OG002 | Prolonged Exposure + Placebo (PE/PLB) | Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure |
|
|
| Secondary | Patient Health Questionnaire-15 | 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 | All Randomized patients who received treatment and had the measure | Posted | Mean | Standard Deviation | Scores on a scale | 24 weeks |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 69 |
| 71 |
| EG001 | Prolonged Exposure + Sertraline (PE/SERT) | 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 | 0 | 69 | 5 | 69 | 61 | 69 |
| EG002 | Prolonged Exposure + Placebo (PE/PLB) | Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure | 0 | 67 | 3 | 67 | 46 | 67 |
| Increased Depression | Psychiatric disorders | Systematic Assessment |
|
| Increased Irritability | Psychiatric disorders | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Endocrine | Endocrine disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
|
| Muskuloskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Psychological | Psychiatric disorders | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |