Post Traumatic Stress DisorderWISENCT05390775
Written Exposure Therapy to Improve Lives After Stress Exposure
A study testing Written Exposure Therapy (WISE) and Non-emotional Writing in people with Post Traumatic Stress Disorder, run by University of North Carolina, Chapel Hill at 6 sites in United States.
Trial summary
The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Written Exposure Therapy (WISE) and Non-emotional Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Aug 2022to 19 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alert and oriented at time of screening
- Written and spoken English
- 18+ years of age
- Presenting to the Emergency Department (ED) within 72 hours of motor vehicle collision
- Discharged home after ED evaluation
- Have an email and mailing address
Show all 9Show fewer
- iOS or android-compatible smart-phone with photo capability, without loss of cellular connection due to inability to pay bill for >1 year, not shared with anyone else
- Meets Posttraumatic Stress Disorder (PTSD) risk score criteria
- Willing to participate in remote therapy sessions
Who cannot join
- Age <18
- Pregnant
- Prisoner or in police custody
- Present to ED >72 hours after trauma
- Have had a change in psychiatric medication regimen 1 month prior to presentation to ED
- Currently receiving cognitive behavioral therapy (CBT) or exposure-based psychological treatment
Show all 9Show fewer
- Self-inflicted or occupational injury
- Ongoing reported domestic violence
- History or condition that in investigator's judgement would likely make a participant non-compliant/unsuitable for participation, including deafness or blindness
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Henry Ford Hospital
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32608
Indiana University
Indianapolis, Indiana, 46202
Washington University in St. Louis
St Louis, Missouri, 63110
University of Massachusetts Chan Medical School (Umass Memorial Medical Center)
Worcester, Massachusetts, 01655
About this study
The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. This data can be used to adequately power a larger randomized controlled trial.
Read the detailed description
Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged to home after evaluation. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) are common in this population, and that individuals with a past history of traumatic stress exposure and/or posttraumatic stress symptoms, such as military veterans, are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. This pilot Written Exposure Therapy to Improve Lives after Stress Exposure (WISE) trial will assess the ability of written exposure therapy to reduce the incidence and severity of PTSD after one of the most common traumatic stress exposures in industrialized countries, motor vehicle collision (MVC). Written exposure therapy is an evidence-based, low-cost intervention that has been demonstrated to be efficacious in treating chronic PTSD symptoms after a variety of traumatic stress exposures, including MVC. However, WISE has never been tested as a secondary preventive intervention. In addition, the efficacy of written exposure therapy when administered as a telehealth intervention has never been assessed, despite the fact that almost a quarter of US veterans live in rural communities that have greater barriers to obtaining in-person care. This WISE pilot trial will randomize 40 individuals who present to a study ED for care after MVC to five sessions of written exposure therapy vs. unemotional writing control. Both exposure and control interventions will be administered via telehealth (n=40), with 20 individuals receiving written exposure therapy and 20 receiving unemotional writing intervention. The same therapists will administer both interventions. Participants will be assessed via traditional self-report surveys. Results of this trial will demonstrate the feasibility and potential efficacy of WISE to reduce the development of PTSD after traumatic stress exposure and will provide the data necessary to design/support a large-scale trial.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Written Exposure Therapy (WISE), Non-emotional Writing
- 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.
Written Exposure Therapy (WISE)Behavioural
WISE consists of five weekly sessions. At session one, the therapist will provide psychoeducation about PTSD, rationale for the proposed intervention, and then instructions for writing about their traumatic experience during each session. Psychoeducation and treatment rationale are scripted to ensure consistency. The participant will be instructed to write about the same trauma memory (their recent MVC) during each session. They will be asked to look back at the event and write for 30 minutes about the details of the event including what they saw, heard, felt, smelled, etc. without regard for spelling or grammar. The participant will self-report SUDs levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session. Therapists will collect the written narrative described above.
Non-emotional WritingBehavioural
Following randomization, the first session for the control writing condition will be conducted as follows, which is detailed in a structured manual for therapists. The therapist will read instructions for writing about non-emotional topics. The participant will be instructed to describe what they did yesterday from the time they woke up until the time they went to bed, as objectively as possible, without regard for spelling or grammar. The therapist will then leave the participant with a written version of the instructions for 30 minutes while the participant writes. As discussed, the participant will self-report Subjective Unites of Distress Scale (SUDS) levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session. Therapists will collect the written narrative described above.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Experimental | Not described Receives: Behavioral: Written Exposure Therapy (WISE) |
| Non-emotional Writing | Placebo comparator | Not described Receives: Behavioral: Non-emotional Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Scores from Baseline to Month 3
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Measured: Baseline, 3-months
Change in PTSD Symptom Scores from Baseline to Month 2
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Measured: Baseline, 2-months
Change in PTSD Symptom Scores from Baseline to Month 1
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Measured: Baseline, 1-month
Secondary outcomes (3)
Change in Pain Symptom Score
The Regional Pain Scale (RPS) is a 19 item scale developed to assess the extent of body pain. Each item is scored on a 0-10 pain scale where 0 is no pain and 10 is severe pain.
Measured: Baseline, 3-months
Change in Somatic Symptom Score
The Pennebaker Inventory of Limbic Languidness (PILL) is a 54-item scale that assesses the frequency of common physical symptoms and sensations. Data presented utilize items from the PILL with response options adapted for greater consistency across measures, greater precision in response levels, and to allow administration via self-report. Each item is scored on a 0-10 scale where 0 is "no problem" and 10 means "a severe problem" with the given symptom.
Measured: Baseline, 3-months
Change in Depressive Symptoms Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b is an 8 item scale developed to assess depression in individuals 18 and older. Each item on the measures is rated on a five-point scale (1=never and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. Questionnaires utilize the 8 items and the same response coding (1-5) with slightly altered response options (i.e. "never" is changed to "none of the time" and "always" is changed to "all or almost all of the time") adapted for greater consistency across measures, greater precision in response levels, and to allow administration via self-report.
Measured: Baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start17 Aug 2022
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida Health, Indiana University, University of Massachusetts, Worcester, Washington University School of Medicine, Henry Ford Health System, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Samuel McLean, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390775
- Sponsor's protocol ID
- 21-3008
- Acronym
- WISE
- Status last verified
- Nov 2023
- First submitted
- 20 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Exposure Therapy to Improve Lives After Stress Exposure
- ClinicalTrials.gov ID
- NCT05390775
- Acronym / sponsor ID
- WISE / 21-3008
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Florida Health, Indiana University, University of Massachusetts, Worcester, Washington University School of Medicine, Henry Ford Health System, US Department of Veterans Affairs
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 25 May 2022 (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.
The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. This data can be used to adequately power a larger randomized controlled trial.
Detailed description
Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged to home after evaluation. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) are common in this population, and that individuals with a past history of traumatic stress exposure and/or posttraumatic stress symptoms, such as military veterans, are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. This pilot Written Exposure Therapy to Improve Lives after Stress Exposure (WISE) trial will assess the ability of written exposure therapy to reduce the incidence and severity of PTSD after one of the most common traumatic stress exposures in industrialized countries, motor vehicle collision (MVC). Written exposure therapy is an evidence-based, low-cost intervention that has been demonstrated to be efficacious in treating chronic PTSD symptoms after a variety of traumatic stress exposures, including MVC. However, WISE has never been tested as a secondary preventive intervention. In addition, the efficacy of written exposure therapy when administered as a telehealth intervention has never been assessed, despite the fact that almost a quarter of US veterans live in rural communities that have greater barriers to obtaining in-person care. This WISE pilot trial will randomize 40 individuals who present to a study ED for care after MVC to five sessions of written exposure therapy vs. unemotional writing control. Both exposure and control interventions will be administered via telehealth (n=40), with 20 individuals receiving written exposure therapy and 20 receiving unemotional writing intervention. The same therapists will administer both interventions. Participants will be assessed via traditional self-report surveys. Results of this trial will demonstrate the feasibility and potential efficacy of WISE to reduce the development of PTSD after traumatic stress exposure and will provide the data necessary to design/support a large-scale trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral: Written Exposure Therapy (WISE) |
| Non-emotional Writing | Placebo comparator | Behavioral: Non-emotional Writing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Alert and oriented at time of screening
- Written and spoken English
- 18+ years of age
- Presenting to the Emergency Department (ED) within 72 hours of motor vehicle collision
- Discharged home after ED evaluation
Key exclusion criteria (9 listed)
- Age <18
- Pregnant
- Prisoner or in police custody
- Present to ED >72 hours after trauma
- Have had a change in psychiatric medication regimen 1 month prior to presentation to ED
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 |
|---|---|---|
| Written Exposure Therapy (WISE)WISE consists of five weekly sessions. At session one, the therapist will provide psychoeducation about PTSD, rationale for the proposed intervention, and then instructions for writing about their traumatic experience during each session. Psychoeducation and treatment rationale are scripted to ensure consistency. The participant will be instructed to write about the same trauma memory (their recent MVC) during each session. They will be asked to look back at the event and write for 30 minutes about the details of the event including what they saw, heard, felt, smelled, etc. without regard for spelling or grammar. The participant will self-report SUDs levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session. Therapists will collect the written narrative described above. | Behavioural | Written Exposure Therapy |
| Non-emotional WritingFollowing randomization, the first session for the control writing condition will be conducted as follows, which is detailed in a structured manual for therapists. The therapist will read instructions for writing about non-emotional topics. The participant will be instructed to describe what they did yesterday from the time they woke up until the time they went to bed, as objectively as possible, without regard for spelling or grammar. The therapist will then leave the participant with a written version of the instructions for 30 minutes while the participant writes. As discussed, the participant will self-report Subjective Unites of Distress Scale (SUDS) levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session. Therapists will collect the written narrative described above. | Behavioural | Non-emotional Writing |
Primary outcome
Change in PTSD Symptom Scores from Baseline to Month 3
Time frame: Baseline, 3-months
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Change in PTSD Symptom Scores from Baseline to Month 2
Time frame: Baseline, 2-months
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Change in PTSD Symptom Scores from Baseline to Month 1
Time frame: Baseline, 1-month
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
3 secondary outcomes
Change in Pain Symptom Score
Time frame: Baseline, 3-months
Change in Somatic Symptom Score
Time frame: Baseline, 3-months
Change in Depressive Symptoms Score
Time frame: Baseline, 3-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 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
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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.
Samuel McLean, MD, MPH principal investigator
University of North Carolina, Chapel Hill
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy (WISE) and Non-emotional Writing in people with Post Traumatic Stress Disorder, run by University of North Carolina, Chapel Hill at 6 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 9 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 Scores from Baseline to Month 3 (time frame: Baseline, 3-months). 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?
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 Nov 2023.