Posttraumatic Stress DisorderPhase 4NCT04961190
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
A Phase 4 study testing Prolonged Exposure Therapy and Pharmacotherapy with paroxetine or venlafaxine XR in people with Posttraumatic Stress Disorder, run by University of Pennsylvania at 7 sites in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged Exposure Therapy and Pharmacotherapy with paroxetine or venlafaxine XR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 May 2022to 1 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-5 diagnosis of Posttraumatic Stress Disorder
- military veteran
- fluent in English
- willing to participate in PE, pharmacotherapy, or both
- capable of providing informed consent
Who cannot join
- suicidal ideation with intent and/or plan, or suicidal behavior in the past month
- active psychosis
- history of manic episode(s)
- a failed trial of Prolonged Exposure therapy or paroxetine and venlafaxine XR
- ongoing medical conditions or treatments that would contraindicate initiating these treatments (e.g., medications that have potential interactions with paroxetine and venlafaxine such as MAO inhibitors)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Birmingham VA Healthcare System
Birmingham, Alabama, 35233
Coatesville VA Medicial Center
Coatesville, Pennsylvania, 19320
VA North Texas Healthcare System
Dallas, Texas, 75216
VA Palo Alto Healthcare System
Menlo Park, California, 94025
Milwaukee VA Medical Center
Milwaukee, Wisconsin, 53295
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best, and for Whom
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness data for PTSD treatments remains a major gap in the literature, which limits conclusions that can be drawn about which of these treatments work best. The current study will compare the effectiveness of PTSD treatments with the strongest evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or venlafaxine - as well as the combination of these two treatments. A randomized trial will be conducted with a large, diverse sample of veterans with PTSD (N = 300) recruited from 6 VA Medical Centers throughout the US. Participants will complete baseline assessments, followed by an active treatment phase (involving up to 14 sessions of PE and/or medication management) with mid (7 week) and posttreatment (14 week) assessments, and follow-up assessments at 27 and 40 weeks. Study outcomes will include PTSD severity, depression, quality of life and functioning, assessed via clinical ratings and self-report measures. Further, a range of demographic and clinically relevant variables (e.g., trauma type/number, resilience) will be collected at baseline and examined as potential predictors or moderators of treatment response, addressing another gap in the PTSD treatment literature. These data will be used to develop algorithms from predicting the optimal treatment for individual patients (i.e., "personalized advantage indices"; PAIs). Effectiveness of the treatments will be compared using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to select variables that predict or moderate outcomes (clinician rated PTSD severity at Week 14), followed by jacknife analyses to determine the magnitude of the predicted difference (representing an individual's "predicted advantage" of one treatment over the others).
Read the detailed description
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness trials for PTSD treatments remains a major gap in the literature, which limits conclusions that can be drawn about which of these treatments work best. In particular, trials directly comparing efficacious psychotherapies and pharmacotherapies are needed to inform clinical decision making for patients and providers. To address this gap, the proposed study will aim to compare the effectiveness of PTSD treatments with the strongest evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or venlafaxine - as well as the combination of these two treatments. A randomized trial in proposed with a large, diverse sample of veterans with PTSD (N = 300) recruited from 6 Veterans Affairs Medical Centers throughout the US (in Philadelphia, Coatesville, Milwaukee, Dallas, San Diego, and Palo Alto). Treatments conditions will reflect "real world" practice in these settings, and minimal exclusion criteria related to safety will be adopted, to maximize external validity. Participants will be permitted to complete treatment sessions in person or via telehealth (based on evidence for equivalent outcomes across these modalities), to maximize patient access, recruitment, and generalizability. Participants will complete baseline assessments, followed by 14 weeks of active treatment (involving up to 14 sessions of PE and/or medication management) with mid and posttreatment assessments after 7 and 14 weeks respectively, and then follow-up assessments at 27 and 40 weeks. Primary outcomes will include PTSD severity, depression symptoms, quality of life and functioning, assessed via clinical ratings and self-report measures. Further, a range of demographic and clinically relevant variables (e.g., trauma type/number, physiological arousal) will be collected at baseline and examined as potential predictors or moderators of treatment response, addressing another key gap in the PTSD treatment literature. Specifically, these data will be used to develop algorithms from predicting the optimal treatment for individual patients (i.e., "personalized advantage indices"; PAIs), a statistical approach which has advanced the depression treatment literature but has only been used in a limited capacity in PTSD research. The project will include an Advisory Board composed of clinician and patient representatives, in order to obtain stakeholder feedback at every stage of the study (from implementation to dissemination of findings). The effectiveness of the treatments will be compared using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to select variables that predict or moderate outcomes (Clinician Administered PTSD Scale severity ratings at Week 14), followed by leave-one-out cross-validation (i.e., jackknife) analyses to determine the magnitude of the predicted difference that results in each analysis representing that individuals "predicted advantage" (of one treatment over the others). We hypothesize that individuals who receive PE will have better outcomes than those who receive pharmacotherapy alone, based on existing data (e.g., cross study effect size comparisons), but have planned the study and sample to maximize statistical power in all analyses.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged Exposure Therapy, Pharmacotherapy with paroxetine or venlafaxine XR
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
A form of cognitive-behavioral psychotherapy focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders
Pharmacotherapy with paroxetine or venlafaxine XRDrug
Also called Pharmacotherapy with Paxil or Effexor XR
Standard dosing with paroxetine, a selectiveserotonin reuptake inhibitor that is FDA approved to treat PTSD and depression, or venlafaxine extended-release, a serotonin-norepinephrine reuptake inhibitor that is FDA approved to treat anxiety and depression
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure Therapy | Active comparator | 8-14 sessions of psychotherapy, each lasting 60-90 minutes, focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders Receives: Behavioral: Prolonged Exposure Therapy |
| Pharmacotherapy | Active comparator | 20-60mg of paroxetine daily, or 75-300mg of venlafaxine XR daily Receives: Drug: Pharmacotherapy with paroxetine or venlafaxine XR |
| Combined treatment (Prolonged Exposure and Pharmacotherapy) | Active comparator | 8-14 sessions of psychotherapy, each lasting 60-90 minutes, focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders AND 20-60mg of paroxetine daily, or 75-300mg of venlafaxine XR daily Receives: Behavioral: Prolonged Exposure Therapy; Drug: Pharmacotherapy with paroxetine or venlafaxine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change during active treatment on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Twenty items are rated on a 5-point scale from 0 (absent) to 4 (extremely/incapacitating). Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity
Measured: baseline to 14 weeks
Change during follow-up on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Twenty items are rated on a 5-point scale from 0 (absent) to 4 (extremely/incapacitating). Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity
Measured: 14 weeks to 40 weeks
Change during active treatment on the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure examining the presence and severity of recent PTSD symptoms using a 0 (not at all) to 4 (extremely) point Likert scale. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Measured: baseline to 14 weeks
Change during follow-up on the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure examining the presence and severity of recent PTSD symptoms using a 0 (not at all) to 4 (extremely) point Likert scale. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Measured: 14 weeks to 40 weeks
Secondary outcomes (8)
Change during active treatment on the Quick Inventory of Depressive Symptoms - clinician rated (QIDS-C)
The QIDS is a structured interview that assesses presence and severity of depressive disorder symptoms. Sixteen items are rated on a 0-3 scale and summed. Total scores range from 0 to 27 (higher scores indicate greater depression symptom severity).
Measured: baseline to 14 weeks
Change during follow-up on the Quick Inventory of Depressive Symptoms - clinician rated (QIDS-C)
The QIDS is a structured interview that assesses presence and severity of depressive disorder symptoms. Sixteen items are rated on a 0-3 scale and summed. Total scores range from 0 to 27 (higher scores indicate greater depression symptom severity).
Measured: 14 weeks to 40 weeks
Change during active treatment on the Patient Health Questionnaire depression module (PHQ-9)
This self-report inventory consists of 9 items that assess depressive symptoms over the past 2 weeks using a scale from 0 (not at all) to 3 (nearly every). Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Measured: baseline to 14 weeks
Change during follow-up on the Patient Health Questionnaire depression module (PHQ-9)
This self-report inventory consists of 9 items that assess depressive symptoms over the past 2 weeks using a scale from 0 (not at all) to 3 (nearly every). Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Measured: 14 weeks to 40 weeks
Change during active treatment on the Social and Occupational Functioning Assessment Scale (SOFAS)
The SOFAS is a global clinical rating scale of current functioning, ranging from 0 to 100 (with higher scores indicated better functioning), which focuses on impairments in social and occupational functioning caused by physical and mental health problems (rated independent of symptom severity).
Measured: baseline to 14 weeks
Change during follow-up on the Social and Occupational Functioning Assessment Scale (SOFAS)
The SOFAS is a global clinical rating scale of current functioning, ranging from 0 to 100 (with higher scores indicated better functioning), which focuses on impairments in social and occupational functioning caused by physical and mental health problems (rated independent of symptom severity).
Measured: 14 weeks to 40 weeks
Change during active treatment on the Veterans RAND 12-item Health Survey (VR-12)
This brief self-report scale was developed (with modified items from the 36 item Short-Form Health Survey) and validated specifically for veterans to assess health-related quality of life, based on reported functioning in multiple domains (e.g., general health, social activities, role limitations). Patients receive a physical component score and a mental component score, and both are scaled so that a score of 50 corresponds to the population average (higher scores indicate better quality of life).
Measured: baseline to 14 weeks
Change during follow-up on the Veterans RAND 12-item Health Survey (VR-12)
This brief self-report scale was developed (with modified items from the 36 item Short-Form Health Survey) and validated specifically for veterans to assess health-related quality of life, based on reported functioning in multiple domains (e.g., general health, social activities, role limitations). Patients receive a physical component score and a mental component score, and both are scaled so that a score of 50 corresponds to the population average (higher scores indicate better quality of life).
Measured: 14 weeks to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start25 May 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Coatesville VA Medical Center, Milwaukee VA Medical Center, North Texas Veterans Healthcare System, San Diego Veterans Healthcare System, VA Palo Alto Health Care System, Birmingham VA Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961190
- Sponsor's protocol ID
- 1620949-1
- Other IDs
- CER-2020C1-19382
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bredemeier K, Larsen S, Shivakumar G, Grubbs K, McLean C, Tress C, Rosenfield D, DeRubeis R, Xu C, Foa E, Morland L, Pai A, Tsao C, Crawford J, Weitz E, Mayinja L, Feler B, Wachsman T, Lupo M, Hooper V, Cook R, Thase M. A comparison of prolonged exposure therapy, pharmacotherapy, and their combination for PTSD: What works best and for whom; study protocol for a randomized trial. Contemp Clin Trials. 2022 Aug;119:106850. doi: 10.1016/j.cct.2022.106850. Epub 2022 Jul 13.
PubMed 35842108
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best, and for Whom
- ClinicalTrials.gov ID
- NCT04961190
- Acronym / sponsor ID
- 1620949-1
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Corporal Michael J. Crescenz VA Medical Center, Coatesville VA Medical Center, Milwaukee VA Medical Center, North Texas Veterans Healthcare System, San Diego Veterans Healthcare System, VA Palo Alto Health Care System, Birmingham VA Health Care System
- Study start
- 25 May 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness data for PTSD treatments remains a major gap in the literature, which limits conclusions that can be drawn about which of these treatments work best. The current study will compare the effectiveness of PTSD treatments with the strongest evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or venlafaxine - as well as the combination of these two treatments. A randomized trial will be conducted with a large, diverse sample of veterans with PTSD (N = 300) recruited from 6 VA Medical Centers throughout the US. Participants will complete baseline assessments, followed by an active treatment phase (involving up to 14 sessions of PE and/or medication management) with mid (7 week) and posttreatment (14 week) assessments, and follow-up assessments at 27 and 40 weeks. Study outcomes will include PTSD severity, depression, quality of life and functioning, assessed via clinical ratings and self-report measures. Further, a range of demographic and clinically relevant variables (e.g., trauma type/number, resilience) will be collected at baseline and examined as potential predictors or moderators of treatment response, addressing another gap in the PTSD treatment literature. These data will be used to develop algorithms from predicting the optimal treatment for individual patients (i.e., "personalized advantage indices"; PAIs). Effectiveness of the treatments will be compared using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to select variables that predict or moderate outcomes (clinician rated PTSD severity at Week 14), followed by jacknife analyses to determine the magnitude of the predicted difference (representing an individual's "predicted advantage" of one treatment over the others).
Detailed description
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness trials for PTSD treatments remains a major gap in the literature, which limits conclusions that can be drawn about which of these treatments work best. In particular, trials directly comparing efficacious psychotherapies and pharmacotherapies are needed to inform clinical decision making for patients and providers. To address this gap, the proposed study will aim to compare the effectiveness of PTSD treatments with the strongest evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or venlafaxine - as well as the combination of these two treatments. A randomized trial in proposed with a large, diverse sample of veterans with PTSD (N = 300) recruited from 6 Veterans Affairs Medical Centers throughout the US (in Philadelphia, Coatesville, Milwaukee, Dallas, San Diego, and Palo Alto). Treatments conditions will reflect "real world" practice in these settings, and minimal exclusion criteria related to safety will be adopted, to maximize external validity. Participants will be permitted to complete treatment sessions in person or via telehealth (based on evidence for equivalent outcomes across these modalities), to maximize patient access, recruitment, and generalizability. Participants will complete baseline assessments, followed by 14 weeks of active treatment (involving up to 14 sessions of PE and/or medication management) with mid and posttreatment assessments after 7 and 14 weeks respectively, and then follow-up assessments at 27 and 40 weeks. Primary outcomes will include PTSD severity, depression symptoms, quality of life and functioning, assessed via clinical ratings and self-report measures. Further, a range of demographic and clinically relevant variables (e.g., trauma type/number, physiological arousal) will be collected at baseline and examined as potential predictors or moderators of treatment response, addressing another key gap in the PTSD treatment literature. Specifically, these data will be used to develop algorithms from predicting the optimal treatment for individual patients (i.e., "personalized advantage indices"; PAIs), a statistical approach which has advanced the depression treatment literature but has only been used in a limited capacity in PTSD research. The project will include an Advisory Board composed of clinician and patient representatives, in order to obtain stakeholder feedback at every stage of the study (from implementation to dissemination of findings). The effectiveness of the treatments will be compared using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to select variables that predict or moderate outcomes (Clinician Administered PTSD Scale severity ratings at Week 14), followed by leave-one-out cross-validation (i.e., jackknife) analyses to determine the magnitude of the predicted difference that results in each analysis representing that individuals "predicted advantage" (of one treatment over the others). We hypothesize that individuals who receive PE will have better outcomes than those who receive pharmacotherapy alone, based on existing data (e.g., cross study effect size comparisons), but have planned the study and sample to maximize statistical power in all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure Therapy | Active comparator | Behavioral: Prolonged Exposure Therapy8-14 sessions of psychotherapy, each lasting 60-90 minutes, focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders |
| Pharmacotherapy | Active comparator | Drug: Pharmacotherapy with paroxetine or venlafaxine XR20-60mg of paroxetine daily, or 75-300mg of venlafaxine XR daily |
| Combined treatment (Prolonged Exposure and Pharmacotherapy) | Active comparator | Behavioral: Prolonged Exposure Therapy, Drug: Pharmacotherapy with paroxetine or venlafaxine XR8-14 sessions of psychotherapy, each lasting 60-90 minutes, focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders AND 20-60mg of paroxetine daily, or 75-300mg of venlafaxine XR daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-5 diagnosis of Posttraumatic Stress Disorder
- military veteran
- fluent in English
- willing to participate in PE, pharmacotherapy, or both
- capable of providing informed consent
Key exclusion criteria (5 listed)
- suicidal ideation with intent and/or plan, or suicidal behavior in the past month
- active psychosis
- history of manic episode(s)
- a failed trial of Prolonged Exposure therapy or paroxetine and venlafaxine XR
- ongoing medical conditions or treatments that would contraindicate initiating these treatments (e.g., medications that have potential interactions with paroxetine and venlafaxine such as MAO inhibitors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyA form of cognitive-behavioral psychotherapy focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders | Behavioural | Combined treatment (Prolonged Exposure and Pharmacotherapy), Prolonged Exposure Therapy |
| Pharmacotherapy with paroxetine or venlafaxine XRAlso: Pharmacotherapy with Paxil or Effexor XRStandard dosing with paroxetine, a selectiveserotonin reuptake inhibitor that is FDA approved to treat PTSD and depression, or venlafaxine extended-release, a serotonin-norepinephrine reuptake inhibitor that is FDA approved to treat anxiety and depression | Drug | Combined treatment (Prolonged Exposure and Pharmacotherapy), Pharmacotherapy |
Primary outcome
Change during active treatment on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: baseline to 14 weeks
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Twenty items are rated on a 5-point scale from 0 (absent) to 4 (extremely/incapacitating). Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity
Change during follow-up on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: 14 weeks to 40 weeks
The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Twenty items are rated on a 5-point scale from 0 (absent) to 4 (extremely/incapacitating). Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity
Change during active treatment on the PTSD Checklist for DSM-5 (PCL-5)
Time frame: baseline to 14 weeks
The PCL-5 is a 20-item self-report measure examining the presence and severity of recent PTSD symptoms using a 0 (not at all) to 4 (extremely) point Likert scale. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Change during follow-up on the PTSD Checklist for DSM-5 (PCL-5)
Time frame: 14 weeks to 40 weeks
The PCL-5 is a 20-item self-report measure examining the presence and severity of recent PTSD symptoms using a 0 (not at all) to 4 (extremely) point Likert scale. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
8 secondary outcomes
Change during active treatment on the Quick Inventory of Depressive Symptoms - clinician rated (QIDS-C)
Time frame: baseline to 14 weeks
Change during follow-up on the Quick Inventory of Depressive Symptoms - clinician rated (QIDS-C)
Time frame: 14 weeks to 40 weeks
Change during active treatment on the Patient Health Questionnaire depression module (PHQ-9)
Time frame: baseline to 14 weeks
Change during follow-up on the Patient Health Questionnaire depression module (PHQ-9)
Time frame: 14 weeks to 40 weeks
Change during active treatment on the Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: baseline to 14 weeks
Change during follow-up on the Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: 14 weeks to 40 weeks
Change during active treatment on the Veterans RAND 12-item Health Survey (VR-12)
Time frame: baseline to 14 weeks
Change during follow-up on the Veterans RAND 12-item Health Survey (VR-12)
Time frame: 14 weeks to 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 35842108Bredemeier K, Larsen S, Shivakumar G, Grubbs K, McLean C, Tress C, Rosenfield D, DeRubeis R, Xu C, Foa E, Morland L, Pai A, Tsao C, Crawford J, Weitz E, Mayinja L, Feler B, Wachsman T, Lupo M, Hooper V, Cook R, Thase M. A comparison of prolonged exposure therapy, pharmacotherapy, and their combination for PTSD: What works best and for whom; study protocol for a randomized trial. Contemp Clin Trials. 2022 Aug;119:106850. doi: 10.1016/j.cct.2022.106850. Epub 2022 Jul 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prolonged Exposure Therapy and Pharmacotherapy with paroxetine or venlafaxine XR in people with Posttraumatic Stress Disorder, run by University of Pennsylvania at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change during active treatment on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: baseline to 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.