Posttraumatic Stress DisordersSTRONG STARNCT01049516
Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) Among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Personnel
A study testing Prolonged Exposure Therapy - Massed, Prolonged Exposure Therapy - Spaced and Present-Centered Therapy in people with Posttraumatic Stress Disorders and Combat Disorders, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorders, Combat Disorders
- What is being tested?
- Prolonged Exposure Therapy - Massed, Prolonged Exposure Therapy - Spaced and Present-Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Aug 2018
- Phase
- Interventional
- 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
- Adult male and female active-duty OIF/OEF military personnel and recently separated OIF/OEF veterans ages 18-65 seeking treatment for PTSD
- Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSS-I).
Who cannot join
- Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)
- Current alcohol dependence (as determined by the AUDIT)
- Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
- Current suicidal ideation severe enough to warrant immediate attention (as determined by the Scale for Suicidal Ideation)
- Other psychiatric disorders severe enough to warrant designation as the primary disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carl R. Darnall Army Medical Center
Killeen, Texas, 76544
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Prolonged Exposure for PTSD Among OIF/OEF Personnel: Massed vs. Spaced Trials
The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT).
Read the detailed description
The purpose of this study is to improve the efficiency of treatment for post-traumatic stress disorder (PTSD) with prolonged exposure (PE), an efficacious treatment for PTSD typically administered in once- or twice-weekly sessions. We will evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) will evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT). Randomization was initially set at 3:11:11:11 for MCC:M-PE:S-PE:PCT. Due to the urgent need for data to inform military clinical practice, enrollment in MCC was accelerated by changing the ratio to 1:1:1:1 in order to report the comparison between M-PE and MCC. When 30 participants were enrolled in MCC, randomization resumed to approximately 3:11:11:11. Prolonged Exposure (PE; Foa, Hembree, \& Rothbaum, 2007; Foa \& Rothbaum, 1998) was developed by the PI, Edna Foa, and colleagues in the Center for the Treatment \& Study of Anxiety (CTSA), University of Pennsylvania. It has been found quite efficacious in reducing PTSD and related psychopathology with various types of trauma in PTSD centers around the world. Furthermore, PE has been identified in the joint VA-Department of Defense Clinical Practice Guideline for PTSD (VA-DoD Clinical Practice Guideline Working Group, 2003) as "strongly recommended" for use with veterans with PTSD, based on the strong empirical support for PE.
This study is part of the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) (Consortium Director: Alan L. Peterson, Ph.D., ABPP, Professor, Behavioral Wellness Center for Clinical Trials, Department of Psychiatry-Mail Code 7792, University of Texas Health Science Center at San Antonio (UTHSCSA), 7703 Floyd Curl Drive, San Antonio, TX 78229-3900). Dr. Edna Foa is the overall PI of the study, and the on-site PI is COL Jeffrey Yarvis, Ph.D.,Chief, Soldier Behavioral Health/Outpatient Psychiatry, Carl R. Darnall Army Medical Center, 36000 Darnall Loop, Fort Hood, TX, 76544. The study will be conducted at Fort Hood, Texas.
- Conditions
- Posttraumatic Stress Disorders, Combat Disorders
- Being tested
- Prolonged Exposure Therapy - Massed, Prolonged Exposure Therapy - Spaced, Minimal Contact Control, Present-Centered Therapy
- Keywords
- Military, Combat, Psychological Treatment, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder, PTSD, Prolonged Exposure, Exposure therapy, Behavior Therapy, Cognitive Behavior Therapy, Post-Traumatic Stress Disorders, Stress Disorders, Post-traumatic
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure Therapy - MassedBehavioural
Also called Massed-PE
10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks.
Prolonged Exposure Therapy - SpacedBehavioural
Also called Spaced-PE
10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions 1-3 occur in the first two weeks, Sessions 4-5 occur in Weeks 3-4, and Sessions 6-10 occur in Weeks 5-10.
Minimal Contact ControlBehavioural
Also called Wait List
Participants receive minimal contact for 4 weeks after randomization and thereafter are offered PE-Spaced or PE-Massed, according to their preference. Participants receive 10-15 minute phone calls once per week by the study therapist or independent evaluator in order to monitor their status and to provide support as needed.
Present-Centered TherapyBehavioural
10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants
| Study group | Role | What they receive |
|---|---|---|
| Minimal Contact Control | Other | Not described Receives: Behavioral: Minimal Contact Control |
| PE-Massed | Experimental | Not described Receives: Behavioral: Prolonged Exposure Therapy - Massed |
| PE-Spaced | Active comparator | Not described Receives: Behavioral: Prolonged Exposure Therapy - Spaced |
| Present-Centered Therapy (PCT) | Active comparator | Not described Receives: Behavioral: Present-Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Affect of treatment on this measure of PTSD symptomology
Measured: Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE
Secondary outcomes (8)
PTSD Checklist-Stressor-specific version (PCL-S)
Affect of treatment on a PTSD Assessment of stress
Measured: Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)
PTSD Checklist-Stressor-specific version (PCL-S)
Changes in PTSD stress symptomology upon commencement of treatment
Measured: Post-treatment to 2-week follow-up
PTSD Checklist-Stressor-specific version (PCL-S)
Changes in PTSD stress symptomology upon commencement of treatment
Measured: 2-week follow-up to 12-week follow-up
PTSD Checklist-Stressor-specific version (PCL-S)
Changes in PTSD stress symptomology upon commencement of treatment
Measured: 12-week follow-up to 6-month follow-up
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) over course of treatment
PTSD Assessment
Measured: Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
PTSD Assessment
Measured: Post-treatment to 2-week follow-up
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
PTSD Assessment
Measured: 2-week follow-up to 12-week follow-up
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
PTSD Assessment
Measured: 12-week follow-up to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2018
- Study completionAug 2018
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 DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Edna B. Foa, Ph.D., Principal investigator, Center for the Treatment and Study of Anxiety, University of PennsylvaniaElna Yadin, Ph.D., Study director, Center for the Treatment and Study of Anxiety, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049516
- Sponsor's protocol ID
- PT074199P13
- Other IDs
- W81XWH-08-2-0111
- Acronym
- STRONG STAR
- Status last verified
- Nov 2018
- First submitted
- 12 Jan 2010
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taylor DJ, Pruiksma KE, Hale W, McLean CP, Zandberg LJ, Brown L, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Dondanville KA, Litz BT, Roache J, Foa EB. Sleep problems in active duty military personnel seeking treatment for posttraumatic stress disorder: presence, change, and impact on outcomes. Sleep. 2020 Oct 13;43(10):zsaa065. doi: 10.1093/sleep/zsaa065.
PubMed 32246153Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23.
PubMed 31176888Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.
PubMed 29362795
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Exposure for PTSD Among OIF/OEF Personnel: Massed vs. Spaced Trials
- ClinicalTrials.gov ID
- NCT01049516
- Acronym / sponsor ID
- STRONG STAR / PT074199P13
- Conditions
- Posttraumatic Stress Disorders, Combat Disorders
- Keywords
- Military, Combat, Psychological Treatment, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, U.S. Army Medical Research and Development Command
- Study start
- Nov 2010
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 14 Jan 2010 (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 purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT).
Detailed description
The purpose of this study is to improve the efficiency of treatment for post-traumatic stress disorder (PTSD) with prolonged exposure (PE), an efficacious treatment for PTSD typically administered in once- or twice-weekly sessions. We will evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) will evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT). Randomization was initially set at 3:11:11:11 for MCC:M-PE:S-PE:PCT. Due to the urgent need for data to inform military clinical practice, enrollment in MCC was accelerated by changing the ratio to 1:1:1:1 in order to report the comparison between M-PE and MCC. When 30 participants were enrolled in MCC, randomization resumed to approximately 3:11:11:11. Prolonged Exposure (PE; Foa, Hembree, \& Rothbaum, 2007; Foa \& Rothbaum, 1998) was developed by the PI, Edna Foa, and colleagues in the Center for the Treatment \& Study of Anxiety (CTSA), University of Pennsylvania. It has been found quite efficacious in reducing PTSD and related psychopathology with various types of trauma in PTSD centers around the world. Furthermore, PE has been identified in the joint VA-Department of Defense Clinical Practice Guideline for PTSD (VA-DoD Clinical Practice Guideline Working Group, 2003) as "strongly recommended" for use with veterans with PTSD, based on the strong empirical support for PE.
This study is part of the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) (Consortium Director: Alan L. Peterson, Ph.D., ABPP, Professor, Behavioral Wellness Center for Clinical Trials, Department of Psychiatry-Mail Code 7792, University of Texas Health Science Center at San Antonio (UTHSCSA), 7703 Floyd Curl Drive, San Antonio, TX 78229-3900). Dr. Edna Foa is the overall PI of the study, and the on-site PI is COL Jeffrey Yarvis, Ph.D.,Chief, Soldier Behavioral Health/Outpatient Psychiatry, Carl R. Darnall Army Medical Center, 36000 Darnall Loop, Fort Hood, TX, 76544. The study will be conducted at Fort Hood, Texas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minimal Contact Control | Other | Behavioral: Minimal Contact Control |
| PE-Massed | Experimental | Behavioral: Prolonged Exposure Therapy - Massed |
| PE-Spaced | Active comparator | Behavioral: Prolonged Exposure Therapy - Spaced |
| Present-Centered Therapy (PCT) | Active comparator | Behavioral: Present-Centered Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male and female active-duty OIF/OEF military personnel and recently separated OIF/OEF veterans ages 18-65 seeking treatment for PTSD
- Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSS-I).
Key exclusion criteria (5 listed)
- Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)
- Current alcohol dependence (as determined by the AUDIT)
- Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
- Current suicidal ideation severe enough to warrant immediate attention (as determined by the Scale for Suicidal Ideation)
- Other psychiatric disorders severe enough to warrant designation as the primary disorder
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 Therapy - MassedAlso: Massed-PE10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks. | Behavioural | PE-Massed |
| Prolonged Exposure Therapy - SpacedAlso: Spaced-PE10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions 1-3 occur in the first two weeks, Sessions 4-5 occur in Weeks 3-4, and Sessions 6-10 occur in Weeks 5-10. | Behavioural | PE-Spaced |
| Minimal Contact ControlAlso: Wait ListParticipants receive minimal contact for 4 weeks after randomization and thereafter are offered PE-Spaced or PE-Massed, according to their preference. Participants receive 10-15 minute phone calls once per week by the study therapist or independent evaluator in order to monitor their status and to provide support as needed. | Behavioural | Minimal Contact Control |
| Present-Centered Therapy10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants | Behavioural | Present-Centered Therapy (PCT) |
Primary outcome
Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Time frame: Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE
Affect of treatment on this measure of PTSD symptomology
8 secondary outcomes
PTSD Checklist-Stressor-specific version (PCL-S)
Time frame: Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)
PTSD Checklist-Stressor-specific version (PCL-S)
Time frame: Post-treatment to 2-week follow-up
PTSD Checklist-Stressor-specific version (PCL-S)
Time frame: 2-week follow-up to 12-week follow-up
PTSD Checklist-Stressor-specific version (PCL-S)
Time frame: 12-week follow-up to 6-month follow-up
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) over course of treatment
Time frame: Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Time frame: Post-treatment to 2-week follow-up
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Time frame: 2-week follow-up to 12-week follow-up
Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) following treatment
Time frame: 12-week follow-up to 6-month follow-up
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 27 Nov 2018.
- Derived from this study: PubMed 32246153Taylor DJ, Pruiksma KE, Hale W, McLean CP, Zandberg LJ, Brown L, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Dondanville KA, Litz BT, Roache J, Foa EB. Sleep problems in active duty military personnel seeking treatment for posttraumatic stress disorder: presence, change, and impact on outcomes. Sleep. 2020 Oct 13;43(10):zsaa065. doi: 10.1093/sleep/zsaa065.
- Derived from this study: PubMed 31176888Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23.
- Derived from this study: PubMed 29362795Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.
- Link to Strong Star research consortiumLink 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.
Edna B. Foa, Ph.D. principal investigator
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Elna Yadin, Ph.D. study director
Center for the Treatment and Study of Anxiety, University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy - Massed, Prolonged Exposure Therapy - Spaced and Present-Centered Therapy in people with Posttraumatic Stress Disorders and Combat Disorders, run by University of Pennsylvania at 3 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 2 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: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment (time frame: Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE). 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 NCT01049516, 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 27 Nov 2018.