Posttraumatic Stress DisorderPhase 3OPTNCT01600456
Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline
A Phase 3 study testing Prolonged exposure (PE) and PE plus Sertraline in people with Posttraumatic Stress Disorder, run by Case Western Reserve University at 2 sites in United States.
Trial summary
The specific aims of this study are: 1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline). 2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment. 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged exposure (PE) and PE plus Sertraline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold)
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment if needed
Who cannot join
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment
- No clear trauma memory or trauma before age 3
- Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
- Ongoing intimate relationship with the perpetrator of the traumatic event
- History of nonresponse to adequate trial of either CBT or sertraline
Show all 9Show fewer
- Medical contraindication for sertraline
- Current high dose use of benzodiazepines
- Pregnant or sexually active female without adequate birth control
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Psychological Sciences Department Case Western Reserve University
Cleveland, Ohio, 44106
Psychology Department of University of Washington
Seattle, Washington, 98195
About this study
Official title: Optimizing PTSD Treatment: PE Versus PE Plus Sertraline
The specific aims of this study are:
- To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline).
- To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment.
- To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment.
- To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.
Read the detailed description
Exposure to traumatic events, such as automobile accidents and physical or sexual assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT (cognitive behavior therapy) and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of prolonged exposure and prolonged exposure plus the antidepressant sertraline.
Participants will either be randomly assigned to prolonged exposure (PE) or PE plus sertraline, or they will be able to choose one of the two treatments,which will be given for 10 weeks, followed by 9 months of follow-up assessments. Participants in the PE group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the PE plus sertraline group receive the same treatment as the PE group plus they will take sertraline daily for 10 weeks. These participants will be seen regularly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the PE plus sertraline group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 9 months. Participants who do not respond to their assigned or chosen treatment will be offered booster sessions or the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, and 9 months after the study treatment period.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged exposure (PE), PE plus Sertraline
- Keywords
- PTSD, Antidepressants, Cognitive behavior therapy
- 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 (PE)Behavioural
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
PE plus SertralineOther
Also called Zoloft
PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Choice: Prolonged exposure (PE) | Active comparator | Participants randomized to "choice" who choose prolonged exposure (PE). Receives: Behavioral: Prolonged exposure (PE) |
| Choice: PE plus sertraline | Active comparator | Participants randomized to "choice" who choose PE plus sertraline. Receives: Behavioral: Prolonged exposure (PE); Other: PE plus Sertraline |
| No choice: Prolonged exposure (PE) | Active comparator | Participants randomized to "no choice" who are then randomized to PE. Receives: Behavioral: Prolonged exposure (PE) |
| No Choice: PE plus sertraline | Active comparator | Participants randomized to "no choice" who are then randomized to PE plus sertraline. Receives: Behavioral: Prolonged exposure (PE); Other: PE plus Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic stress disorder (PTSD) Symptoms
Interview measure to assess PTSD symptoms.
Measured: Measured up to 9 months.
Secondary outcomes (1)
Depression symptoms
Clinical assessment of depression symptoms.
Measured: Measured up to 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Norah Feeny, Case Western Reserve University
- Investigators
- Norah C Feeny, PhD, Principal investigator, Case Western Reserve UniversityLori A Zoellner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600456
- Sponsor's protocol ID
- Optimizing1
- Other IDs
- R01MH066348-07, R01MH066347-07
- Acronym
- OPT
- Status last verified
- Aug 2021
- First submitted
- 11 May 2012
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosencrans PL, Walker RSW, Coyne AE, Baier AL, Klein AB, Shekhtman K, Bowling AR, Feeny NC, Zoellner LA. Reciprocal relationships between posttraumatic stress disorder symptoms and positive and negative affect in evidence-based treatments for posttraumatic stress disorder. J Consult Clin Psychol. 2024 Sep;92(9):630-640. doi: 10.1037/ccp0000898.
PubMed 39418460Coyne AE, Mattson E, Bagley JM, Klein AB, Shekhtman K, Payat S, Levine DS, Feeny NC, Zoellner LA. Within-patient association between emotion regulation and outcome in prolonged exposure for posttraumatic stress disorder. J Consult Clin Psychol. 2024 Sep;92(9):582-593. doi: 10.1037/ccp0000837. Epub 2023 Nov 16.
PubMed 37971811Rosencrans PL, Zoellner LA, Feeny NC. A network approach to posttraumatic stress disorder: Comparing interview and self-report networks. Psychol Trauma. 2024 Feb;16(2):340-346. doi: 10.1037/tra0001151. Epub 2021 Oct 21.
PubMed 34672659
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing PTSD Treatment: PE Versus PE Plus Sertraline
- ClinicalTrials.gov ID
- NCT01600456
- Acronym / sponsor ID
- OPT / Optimizing1
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Antidepressants, Cognitive behavior therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University of Washington, National Institute of Mental Health (NIMH)
- Study start
- Mar 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 May 2012 (estimated)
- 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.
The specific aims of this study are:
- To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline).
- To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment.
- To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment.
- To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.
Detailed description
Exposure to traumatic events, such as automobile accidents and physical or sexual assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT (cognitive behavior therapy) and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of prolonged exposure and prolonged exposure plus the antidepressant sertraline.
Participants will either be randomly assigned to prolonged exposure (PE) or PE plus sertraline, or they will be able to choose one of the two treatments,which will be given for 10 weeks, followed by 9 months of follow-up assessments. Participants in the PE group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the PE plus sertraline group receive the same treatment as the PE group plus they will take sertraline daily for 10 weeks. These participants will be seen regularly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the PE plus sertraline group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 9 months. Participants who do not respond to their assigned or chosen treatment will be offered booster sessions or the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, and 9 months after the study treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Choice: Prolonged exposure (PE) | Active comparator | Behavioral: Prolonged exposure (PE)Participants randomized to "choice" who choose prolonged exposure (PE). |
| Choice: PE plus sertraline | Active comparator | Behavioral: Prolonged exposure (PE), Other: PE plus SertralineParticipants randomized to "choice" who choose PE plus sertraline. |
| No choice: Prolonged exposure (PE) | Active comparator | Behavioral: Prolonged exposure (PE)Participants randomized to "no choice" who are then randomized to PE. |
| No Choice: PE plus sertraline | Active comparator | Behavioral: Prolonged exposure (PE), Other: PE plus SertralineParticipants randomized to "no choice" who are then randomized to PE plus sertraline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold)
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment if needed
Key exclusion criteria (9 listed)
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment
- No clear trauma memory or trauma before age 3
- Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
- Ongoing intimate relationship with the perpetrator of the traumatic event
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 (PE)PE will include 10 weekly sessions of individual cognitive behavioral therapy. | Behavioural | Choice: PE plus sertraline, Choice: Prolonged exposure (PE), No Choice: PE plus sertraline, No choice: Prolonged exposure (PE) |
| PE plus SertralineAlso: ZoloftPE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks. | Other | Choice: PE plus sertraline, No Choice: PE plus sertraline |
Primary outcome
Posttraumatic stress disorder (PTSD) Symptoms
Time frame: Measured up to 9 months.
Interview measure to assess PTSD symptoms.
1 secondary outcome
Depression symptoms
Time frame: Measured up to 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Derived from this study: PubMed 39418460Rosencrans PL, Walker RSW, Coyne AE, Baier AL, Klein AB, Shekhtman K, Bowling AR, Feeny NC, Zoellner LA. Reciprocal relationships between posttraumatic stress disorder symptoms and positive and negative affect in evidence-based treatments for posttraumatic stress disorder. J Consult Clin Psychol. 2024 Sep;92(9):630-640. doi: 10.1037/ccp0000898.
- Derived from this study: PubMed 37971811Coyne AE, Mattson E, Bagley JM, Klein AB, Shekhtman K, Payat S, Levine DS, Feeny NC, Zoellner LA. Within-patient association between emotion regulation and outcome in prolonged exposure for posttraumatic stress disorder. J Consult Clin Psychol. 2024 Sep;92(9):582-593. doi: 10.1037/ccp0000837. Epub 2023 Nov 16.
- Derived from this study: PubMed 34672659Rosencrans PL, Zoellner LA, Feeny NC. A network approach to posttraumatic stress disorder: Comparing interview and self-report networks. Psychol Trauma. 2024 Feb;16(2):340-346. doi: 10.1037/tra0001151. Epub 2021 Oct 21.
- Optimizing PTSD Treatment's HomepageLink provided by the sponsor.
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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.
Norah C Feeny, PhD principal investigator
Case Western Reserve University
Lori A Zoellner, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prolonged exposure (PE) and PE plus Sertraline in people with Posttraumatic Stress Disorder, run by Case Western Reserve University at 2 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Posttraumatic stress disorder (PTSD) Symptoms (time frame: Measured up to 9 months.). 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 NCT01600456, which also lists 3 linked publications.
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 3 Aug 2021.