PTSDNCT03962504
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
A study testing trauma-focused treatment in people with PTSD, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- trauma-focused treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Sep 2019to 30 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status
- Current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; CAPS-5)
- If taking psychotropic medication, on a stable dose for at least 30 days prior to study entry
Who cannot join
- Current engagement psychosocial treatment for PTSD
- Current diagnosis of substance dependence
- abuse will not be excluded; determined with severe combined immunodeficiency (SCID)
- Current psychosis or unstable bipolar disorder diagnosis
- determined with the Mini International Neuropsychiatric Interview (MINI)clinician-administered interview
- High suicidal risk
- i.e., intent with a plan; assessed with the MINI suicide module
- Significant cognitive impairment (assessed with the Montreal Cognitive Assessment [MoCA] and clinical judgment)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
About this study
Official title: An Efficient, Exposure-based Treatment for PTSD Compared to Prolonged Exposure: A Non-inferiority Randomized Trial
The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.
Read the detailed description
Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.
- Conditions
- PTSD
- Being tested
- trauma-focused treatment
- Keywords
- PTSD, psychosocial treatment, cognitive behavioral treatment, veterans, quality of life
- 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.
trauma-focused treatmentBehavioural
cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
| Study group | Role | What they receive |
|---|---|---|
| written exposure therapy | Experimental | The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. Receives: Behavioral: trauma-focused treatment |
| Prolonged Exposure | Active comparator | Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures Receives: Behavioral: trauma-focused treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)
The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer.
Scores can range from 0-80, with higher scores indicating greater severity.
Measured: change score baseline to 20 weeks
Secondary outcomes (1)
World Health Organization Quality of Life BREF
The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete.
Total score 0-100, with higher scores indicate greater quality of life.
Measured: change score baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start9 Sep 2019
- Primary completion2 Jan 2023
- Study completion30 Dec 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- The study is a non-inferiority design to examine if a brief intervention for PTSD is non-inferior to a more time-intensive intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Denise M Sloan, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962504
- Sponsor's protocol ID
- MHBB-005-18F
- Other IDs
- CX001967-01
- Status last verified
- Apr 2024
- First submitted
- 22 May 2019
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets meeting VA standards for disclosure to the public will be made available within 1 year after publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information (PHI). Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by Office of Research and Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.
Publications
Sloan DM, Marx BP, Acierno R, Messina M, Muzzy W, Gallagher MW, Litwack S, Sloan C. Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1093-1100. doi: 10.1001/jamapsychiatry.2023.2810.
PubMed 37610727
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficient, Exposure-based Treatment for PTSD Compared to Prolonged Exposure: A Non-inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT03962504
- Acronym / sponsor ID
- MHBB-005-18F
- Conditions
- PTSD
- Keywords
- PTSD, psychosocial treatment, cognitive behavioral treatment, veterans, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.
Detailed description
Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a non-inferiority design to examine if a brief intervention for PTSD is non-inferior to a more time-intensive intervention.
| Arm | Type | Receives |
|---|---|---|
| written exposure therapy | Experimental | Behavioral: trauma-focused treatmentThe WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. |
| Prolonged Exposure | Active comparator | Behavioral: trauma-focused treatmentProlonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran status
- Current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; CAPS-5)
- If taking psychotropic medication, on a stable dose for at least 30 days prior to study entry
Key exclusion criteria (8 listed)
- Current engagement psychosocial treatment for PTSD
- Current diagnosis of substance dependence
- Current psychosis or unstable bipolar disorder diagnosis
- High suicidal risk
- Significant cognitive impairment (assessed with the Montreal Cognitive Assessment [MoCA] and clinical judgment)
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 |
|---|---|---|
| trauma-focused treatmentcognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. | Behavioural | Prolonged Exposure, written exposure therapy |
Primary outcome
Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)
Time frame: change score baseline to 20 weeks
The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity.
1 secondary outcome
World Health Organization Quality of Life BREF
Time frame: change score baseline to 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37610727Sloan DM, Marx BP, Acierno R, Messina M, Muzzy W, Gallagher MW, Litwack S, Sloan C. Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1093-1100. doi: 10.1001/jamapsychiatry.2023.2810.
- Individual participant dataSharing planned: Yes. Datasets meeting VA standards for disclosure to the public will be made available within 1 year after publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information (PHI). Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by Office of Research and Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Denise M Sloan, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trauma-focused treatment in people with PTSD, run by VA Office of Research and Development 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 3 inclusion and 8 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 18 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2024). 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?
Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) (time frame: change score baseline to 20 weeks). 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 NCT03962504, 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 18 Jul 2024.