Post-Traumatic Stress DisorderPhase 3NCT00127673
Comparison of Two Treatments for Post-Traumatic Stress Disorder
A Phase 3 study testing Sertraline and Cognitive behavioral therapy (CBT) in people with Post-Traumatic Stress Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Sertraline and Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 diagnosis of PTSD
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment
Who cannot join
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
- 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 either CBT or sertraline
- Medical contraindication for sertraline
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, University of Washington
Seattle, Washington, 98195
About this study
Official title: Effectiveness of PTSD Treatment: CBT Versus Sertraline
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.
Read the detailed description
Exposure to traumatic events, such as automobile accidents and 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 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 CBT and the antidepressant sertraline.
Participants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT 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 antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly 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 antidepressant 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 24 months. Participants who do not respond to their assigned or chosen treatment will be offered 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, 12, and 24 months after the study treatment period.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Sertraline, Cognitive behavioral therapy (CBT)
- Keywords
- 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.
SertralineDrug
Also called Zoloft
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
Cognitive behavioral therapy (CBT)Behavioural
Also called Prolonged exposure (PE)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| CBT no choice | Active comparator | Participants will receive no choice cognitive behavioral therapy (CBT no choice) Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| CBT choice | Active comparator | Participants will receive choice cognitive behavioral therapy (CBT choice) Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| sertraline no choice | Active comparator | Participants will receive no choice sertraline (sertraline no choice) Receives: Drug: Sertraline |
| sertraline choice | Active comparator | Participants will receive choice sertraline (sertraline choice) Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms
total score, range from 0-80, higher scores are more severe
Measured: Post-treatment, ten weeks
Depression Symptoms
Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression
Measured: Measured at Post-Treatment, at 10 weeks
State Anxiety
State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe
Measured: Measured at Post-Treatment, at 10 weeks
Secondary outcomes (1)
Quality of Life Functioning
Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment
Measured: Measured at Post-Treatment, at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Norah Feeny, Case Western Reserve University
- Investigators
- Norah C. Feeny, PhD, Principal investigator, Department of Psychology, Case Western Reserve UniversityLori A. Zoellner, PhD, Principal investigator, Department of Psychology, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127673
- Sponsor's protocol ID
- R01MH066347
- Other IDs
- R01MH066348
- Status last verified
- Apr 2022
- First submitted
- 5 Aug 2005
- Last updated
- 24 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gauthier GM, PeConga EK, Mohr JL, Feeny NC, Zoellner LA. Prospective stability of memory for peritraumatic dissociation and anxiety: Replication and extension examining PTSD treatment modality and response. Psychol Trauma. 2025 Feb;17(2):429-437. doi: 10.1037/tra0001790. Epub 2024 Nov 7.
PubMed 39509231Rosencrans 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 34672659Graham B, Garcia NM, Bergman HE, Feeny NC, Zoellner LA. Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning. J Trauma Stress. 2020 Aug;33(4):488-499. doi: 10.1002/jts.22570. Epub 2020 Jul 13.
PubMed 32662191Zoellner LA, Roy-Byrne PP, Mavissakalian M, Feeny NC. Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD. Am J Psychiatry. 2019 Apr 1;176(4):287-296. doi: 10.1176/appi.ajp.2018.17090995. Epub 2018 Oct 19.
PubMed 30336702Le QA, Doctor JN, Zoellner LA, Feeny NC. Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD). Qual Life Res. 2018 Jun;27(6):1555-1562. doi: 10.1007/s11136-018-1833-4. Epub 2018 Mar 14.
PubMed 29541927Le QA, Doctor JN, Zoellner LA, Feeny NC. Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder (the Optimizing PTSD Treatment Trial): a doubly randomized preference trial. J Clin Psychiatry. 2014 Mar;75(3):222-30. doi: 10.4088/JCP.13m08719.
PubMed 24717377Le QA, Doctor JN, Zoellner LA, Feeny NC. Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT). Health Qual Life Outcomes. 2013 Apr 12;11:59. doi: 10.1186/1477-7525-11-59.
PubMed 23587015
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PTSD Treatment: CBT Versus Sertraline
- ClinicalTrials.gov ID
- NCT00127673
- Acronym / sponsor ID
- R01MH066347
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Antidepressants, Cognitive behavior therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Posted 24 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.
Detailed description
Exposure to traumatic events, such as automobile accidents and 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 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 CBT and the antidepressant sertraline.
Participants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT 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 antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly 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 antidepressant 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 24 months. Participants who do not respond to their assigned or chosen treatment will be offered 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, 12, and 24 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 |
|---|---|---|
| CBT no choice | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Participants will receive no choice cognitive behavioral therapy (CBT no choice) |
| CBT choice | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Participants will receive choice cognitive behavioral therapy (CBT choice) |
| sertraline no choice | Active comparator | Drug: SertralineParticipants will receive no choice sertraline (sertraline no choice) |
| sertraline choice | Active comparator | Drug: SertralineParticipants will receive choice sertraline (sertraline choice) |
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 diagnosis of PTSD
- Experienced traumatic event at least 12 weeks prior to study entry
- Willingness to discontinue current CBT or antidepressant treatment
Key exclusion criteria (6 listed)
- Current diagnosis of schizophrenia or delusional disorder
- Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
- 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 either CBT or sertraline
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 |
|---|---|---|
| SertralineAlso: ZoloftThe dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist. | Drug | sertraline choice, sertraline no choice |
| Cognitive behavioral therapy (CBT)Also: Prolonged exposure (PE)CBT will include 10 weekly sessions of individual cognitive behavioral therapy. | Behavioural | CBT choice, CBT no choice |
Primary outcome
PTSD Symptoms
Time frame: Post-treatment, ten weeks
total score, range from 0-80, higher scores are more severe
Depression Symptoms
Time frame: Measured at Post-Treatment, at 10 weeks
Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression
State Anxiety
Time frame: Measured at Post-Treatment, at 10 weeks
State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe
1 secondary outcome
Quality of Life Functioning
Time frame: Measured at Post-Treatment, at 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39509231Gauthier GM, PeConga EK, Mohr JL, Feeny NC, Zoellner LA. Prospective stability of memory for peritraumatic dissociation and anxiety: Replication and extension examining PTSD treatment modality and response. Psychol Trauma. 2025 Feb;17(2):429-437. doi: 10.1037/tra0001790. Epub 2024 Nov 7.
- 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.
- Derived from this study: PubMed 32662191Graham B, Garcia NM, Bergman HE, Feeny NC, Zoellner LA. Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning. J Trauma Stress. 2020 Aug;33(4):488-499. doi: 10.1002/jts.22570. Epub 2020 Jul 13.
- Derived from this study: PubMed 30336702Zoellner LA, Roy-Byrne PP, Mavissakalian M, Feeny NC. Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD. Am J Psychiatry. 2019 Apr 1;176(4):287-296. doi: 10.1176/appi.ajp.2018.17090995. Epub 2018 Oct 19.
- Derived from this study: PubMed 29541927Le QA, Doctor JN, Zoellner LA, Feeny NC. Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD). Qual Life Res. 2018 Jun;27(6):1555-1562. doi: 10.1007/s11136-018-1833-4. Epub 2018 Mar 14.
- Derived from this study: PubMed 24717377Le QA, Doctor JN, Zoellner LA, Feeny NC. Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder (the Optimizing PTSD Treatment Trial): a doubly randomized preference trial. J Clin Psychiatry. 2014 Mar;75(3):222-30. doi: 10.4088/JCP.13m08719.
- Derived from this study: PubMed 23587015Le QA, Doctor JN, Zoellner LA, Feeny NC. Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT). Health Qual Life Outcomes. 2013 Apr 12;11:59. doi: 10.1186/1477-7525-11-59.
- Click here for more information about the effectiveness of CBT and sertraline for PTSDLink 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
Department of Psychology, Case Western Reserve University
Lori A. Zoellner, PhD principal investigator
Department of Psychology, University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sertraline and Cognitive behavioral therapy (CBT) in people with Post-Traumatic Stress Disorder, run by Case Western Reserve University at 1 site 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 6 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PTSD Symptoms (time frame: Post-treatment, ten weeks). The study lists 3 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 NCT00127673, which also lists 7 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 24 May 2022.