Written Exposure TherapyNCT04000217
Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy
A study testing Written Exposure Therapy and Imaginal Exposure Therapy in people with Written Exposure Therapy and Imaginal Exposure Therapy, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Written Exposure Therapy, Imaginal Exposure Therapy
- What is being tested?
- Written Exposure Therapy and Imaginal Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 9 Sep 2022
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read/write English
- Internet connection allowing stable access to the Vets Prevail website
- A clinically significant PCL-5 score of 31 or above.
Who cannot join
- A score on the suicidality item of the PHQ-9 of 3 or higher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial Comparing Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy Delivered Online
The purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Both treatments will be delivered through an interactive online program with coaching from a trained peer support specialist. Treatment will be a variable length, such that 4 to 8 sessions will be delivered, depending on each participants' rate of PTSD symptom recovery.
- Being tested
- Written Exposure Therapy, Imaginal Exposure Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
In this study, written exposure therapy is delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved).
Imaginal Exposure TherapyBehavioural
Delivery of imaginal exposure in this study will mirror the procedures used in WET. It will be delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved).
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Active comparator | Written exposure therapy (Sloan et al., 2012) is a brief evidence-based treatment for PTSD (US Dept. of VA \& DoD, 2017), wherein patients are asked to write about their trauma memories for 30 minutes, with therapist instruction and feedback before and after each writing exercise. Receives: Behavioral: Written Exposure Therapy |
| Imaginal Exposure Therapy | Active comparator | Imaginal exposure therapy will involve verbal recounting of trauma memories for 30 minutes with therapist instruction and feedback before and after each recounting exercise. Receives: Behavioral: Imaginal Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)
Self report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate greater PTSD severity.
Measured: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Secondary outcomes (3)
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Self report measure of depression symptoms. It is the 9-item measure that yields a total score of 0-27, with higher scores indicating greater depressive symptom severity.
Measured: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)
A 16-item self report measure of difficulties in emotion regulation. Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
Measured: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
A 5-item self-report measure of work and social functioning and impact of symptoms. Total scores range from 0-40 with higher scores indicating greater impairment.
Measured: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start20 Jan 2020
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Written Exposure TherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen McLean, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000217
- Sponsor's protocol ID
- 640C89370
- Status last verified
- Feb 2023
- First submitted
- 24 Jun 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McLean CP, Malek N, Straud CL. A pilot randomized controlled trial of online written exposure therapy delivered by peer coaches to veterans with posttraumatic stress disorder. J Trauma Stress. 2024 Jun;37(3):471-482. doi: 10.1002/jts.23020. Epub 2024 Feb 13.
PubMed 38348490
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Comparing Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy Delivered Online
- ClinicalTrials.gov ID
- NCT04000217
- Acronym / sponsor ID
- 640C89370
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 27 Jun 2019 (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 purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Both treatments will be delivered through an interactive online program with coaching from a trained peer support specialist. Treatment will be a variable length, such that 4 to 8 sessions will be delivered, depending on each participants' rate of PTSD symptom recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Active comparator | Behavioral: Written Exposure TherapyWritten exposure therapy (Sloan et al., 2012) is a brief evidence-based treatment for PTSD (US Dept. of VA \& DoD, 2017), wherein patients are asked to write about their trauma memories for 30 minutes, with therapist instruction and feedback before and after each writing exercise. |
| Imaginal Exposure Therapy | Active comparator | Behavioral: Imaginal Exposure TherapyImaginal exposure therapy will involve verbal recounting of trauma memories for 30 minutes with therapist instruction and feedback before and after each recounting exercise. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to read/write English
- Internet connection allowing stable access to the Vets Prevail website
- A clinically significant PCL-5 score of 31 or above.
Key exclusion criteria (1 listed)
- A score on the suicidality item of the PHQ-9 of 3 or higher.
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 TherapyIn this study, written exposure therapy is delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved). | Behavioural | Written Exposure Therapy |
| Imaginal Exposure TherapyDelivery of imaginal exposure in this study will mirror the procedures used in WET. It will be delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved). | Behavioural | Imaginal Exposure Therapy |
Primary outcome
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)
Time frame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Self report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate greater PTSD severity.
3 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Time frame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)
Time frame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
Time frame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
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 2 Mar 2023.
- Derived from this study: PubMed 38348490McLean CP, Malek N, Straud CL. A pilot randomized controlled trial of online written exposure therapy delivered by peer coaches to veterans with posttraumatic stress disorder. J Trauma Stress. 2024 Jun;37(3):471-482. doi: 10.1002/jts.23020. Epub 2024 Feb 13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Imaginal Exposure Therapy in people with Written Exposure Therapy and Imaginal Exposure Therapy, run by Palo Alto Veterans Institute for Research 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 1 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 2 Mar 2023. 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.
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?
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013) (time frame: Change in total score from baseline to 3-months post treatment (approximately 14-18 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 NCT04000217, 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 2 Mar 2023.