Post-Traumatic Stress DisorderNCT00862498
Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
A study testing Written Disclosure in people with Post-Traumatic Stress Disorder, run by Boston University at 1 site in United States.
Trial summary
This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Written Disclosure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of post-traumatic stress disorder
- Involved in motor vehicle accident that occurred at least 3 months ago
Who cannot join
- Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression
- History of psychosis
- Active suicidality or history of two or more suicide gestures or attempts in the past year
- Significant cognitive impairment
- Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System, National Center for PTSD
Boston, Massachusetts, 02130
About this study
Official title: Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a chronic and debilitating disorder caused by experiencing a stressful or traumatic event. Although there is evidence that treatments for PTSD are effective, many people do not seek treatment or seek treatment only after their PTSD has become severe. This study will test a low-cost, brief, and easily implemented treatment that may encourage people to seek treatment for PTSD. The treatment, called written disclosure (WD), involves writing about the traumatic event that caused a person's PTSD. In this study, people who have PTSD as the result of a motor vehicle accident will test two versions of WD, one administered in a clinic and the other administered over the phone.
Participation in this study will last 5 weeks, with follow-up assessments continuing until 6 months after treatment. After screening, participants will be assigned to one of three conditions: WD treatment delivered in the clinic, WD treatment delivered via phone, and waitlist. The WD treatment involves five weekly writing sessions. During the first session, trauma reactions and the rationale for WD will be explained to all participants, and then participants will write for 30 minutes about their motor vehicle accident. The next four sessions will involve only writing for 30 minutes. For those receiving treatment in the clinic, a therapist will communicate directions and explanations to participants, and participants will have their heart rate activity recorded continuously for 5 minutes prior to writing and during the 30 minutes of writing. For those receiving treatment over the phone, explanations of the study will be provided in writing, and a study staff member will call participants before and after each writing session to ensure that participants understand the directions and are not experiencing any unexpected negative reactions after writing. Participants in the waitlist condition will not receive treatment for the first 4 months. After that period, they will be offered the WD treatment.
Assessments of all participants will occur at baseline, after treatment, and 3 months after treatment. Participants assigned to receive WD treatment, either in a clinic or via phone, will also be assessed 6 months after treatment. Assessments administered at these points will involve semi-structured clinical interviews, self-report questionnaires, and measures of mood-related symptoms. Participants receiving treatment will also complete self-report measurements of emotional response after each writing session and the Daily Experiences Questionnaire every day during the 5 weeks of treatment. Participants on the waitlist will also undergo assessments of suicidal thoughts and PTSD symptoms every 2 weeks.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Written Disclosure
- Keywords
- PTSD, Written Disclosure, Written Emotional Disclosure, Narrative Exposure, Narrative Writing, Motor Vehicle Accident
- 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 DisclosureOther
Also called Written Emotional Disclosure, Narrative Writing, Narrative Exposure
Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes. The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Treatment in Clinic | Experimental | Participants will complete the written disclosure treatment in a clinic setting. Receives: Other: Written Disclosure |
| Group 2 Treatment via telephone | Experimental | Participants will complete the written disclosure treatment in their homes via telephone. Receives: Other: Written Disclosure |
| Group 3 Waitlist | No intervention | Individuals will be placed on a waitlist for a period of 4 months, during which they will receive a phone call every other week to assess their suicidal ideation and post-traumatic stress disorder symptom severity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered Posttraumatic Stress Disorder Scale
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Secondary outcomes (12)
Beck Depression Inventory - Second Edition
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Posttraumatic Cognitions Inventory
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Anxious Driving Questionnaire
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Client Satisfaction Questionnaire
Measured: Measured at the end of the last treatment session
Daily Experiences Questionnaire
Measured: Measured every day during the 5-week treatment period
Oswestry Disability Index
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Quality of Life Inventory
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Self-Assessment Manikin
Measured: Measured after each writing session
Last Day of Writing Questionnaire
Measured: Measured after the last writing session
Follow-Up Writing Questionnaire
Measured: Measured after the 3-month follow-up assessment
Alcohol Use Disorders Identification Test
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Posttraumatic Stress Disorder Checklist - Civilian Version
Measured: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionAug 2011
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 Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Denise M. Sloan, Boston University
- Investigators
- Denise M. Sloan, PhD, Principal investigator, VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862498
- Sponsor's protocol ID
- H-27236
- Other IDs
- R34MH077658
- Status last verified
- Feb 2018
- First submitted
- 16 Mar 2009
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sloan DM, Marx BP, Bovin MJ, Feinstein BA, Gallagher MW. Written exposure as an intervention for PTSD: a randomized clinical trial with motor vehicle accident survivors. Behav Res Ther. 2012 Oct;50(10):627-35. doi: 10.1016/j.brat.2012.07.001. Epub 2012 Jul 20.
PubMed 22863540
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00862498
- Acronym / sponsor ID
- H-27236
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Written Disclosure, Written Emotional Disclosure, Narrative Exposure, Narrative Writing, Motor Vehicle Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Mar 2009 (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.
This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.
Detailed description
Post-traumatic stress disorder (PTSD) is a chronic and debilitating disorder caused by experiencing a stressful or traumatic event. Although there is evidence that treatments for PTSD are effective, many people do not seek treatment or seek treatment only after their PTSD has become severe. This study will test a low-cost, brief, and easily implemented treatment that may encourage people to seek treatment for PTSD. The treatment, called written disclosure (WD), involves writing about the traumatic event that caused a person's PTSD. In this study, people who have PTSD as the result of a motor vehicle accident will test two versions of WD, one administered in a clinic and the other administered over the phone.
Participation in this study will last 5 weeks, with follow-up assessments continuing until 6 months after treatment. After screening, participants will be assigned to one of three conditions: WD treatment delivered in the clinic, WD treatment delivered via phone, and waitlist. The WD treatment involves five weekly writing sessions. During the first session, trauma reactions and the rationale for WD will be explained to all participants, and then participants will write for 30 minutes about their motor vehicle accident. The next four sessions will involve only writing for 30 minutes. For those receiving treatment in the clinic, a therapist will communicate directions and explanations to participants, and participants will have their heart rate activity recorded continuously for 5 minutes prior to writing and during the 30 minutes of writing. For those receiving treatment over the phone, explanations of the study will be provided in writing, and a study staff member will call participants before and after each writing session to ensure that participants understand the directions and are not experiencing any unexpected negative reactions after writing. Participants in the waitlist condition will not receive treatment for the first 4 months. After that period, they will be offered the WD treatment.
Assessments of all participants will occur at baseline, after treatment, and 3 months after treatment. Participants assigned to receive WD treatment, either in a clinic or via phone, will also be assessed 6 months after treatment. Assessments administered at these points will involve semi-structured clinical interviews, self-report questionnaires, and measures of mood-related symptoms. Participants receiving treatment will also complete self-report measurements of emotional response after each writing session and the Daily Experiences Questionnaire every day during the 5 weeks of treatment. Participants on the waitlist will also undergo assessments of suicidal thoughts and PTSD symptoms every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Treatment in Clinic | Experimental | Other: Written DisclosureParticipants will complete the written disclosure treatment in a clinic setting. |
| Group 2 Treatment via telephone | Experimental | Other: Written DisclosureParticipants will complete the written disclosure treatment in their homes via telephone. |
| Group 3 Waitlist | No intervention | –Individuals will be placed on a waitlist for a period of 4 months, during which they will receive a phone call every other week to assess their suicidal ideation and post-traumatic stress disorder symptom severity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of post-traumatic stress disorder
- Involved in motor vehicle accident that occurred at least 3 months ago
Key exclusion criteria (5 listed)
- Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression
- History of psychosis
- Active suicidality or history of two or more suicide gestures or attempts in the past year
- Significant cognitive impairment
- Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician
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 DisclosureAlso: Written Emotional Disclosure, Narrative Writing, Narrative ExposureFive sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes. The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment. | Other | Group 1 Treatment in Clinic, Group 2 Treatment via telephone |
Primary outcome
Clinician-Administered Posttraumatic Stress Disorder Scale
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
12 secondary outcomes
Beck Depression Inventory - Second Edition
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Posttraumatic Cognitions Inventory
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Anxious Driving Questionnaire
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Client Satisfaction Questionnaire
Time frame: Measured at the end of the last treatment session
Daily Experiences Questionnaire
Time frame: Measured every day during the 5-week treatment period
Oswestry Disability Index
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Quality of Life Inventory
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Self-Assessment Manikin
Time frame: Measured after each writing session
Last Day of Writing Questionnaire
Time frame: Measured after the last writing session
Follow-Up Writing Questionnaire
Time frame: Measured after the 3-month follow-up assessment
Alcohol Use Disorders Identification Test
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Posttraumatic Stress Disorder Checklist - Civilian Version
Time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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 28 Feb 2018.
- Results publication: PubMed 22863540Sloan DM, Marx BP, Bovin MJ, Feinstein BA, Gallagher MW. Written exposure as an intervention for PTSD: a randomized clinical trial with motor vehicle accident survivors. Behav Res Ther. 2012 Oct;50(10):627-35. doi: 10.1016/j.brat.2012.07.001. Epub 2012 Jul 20.
- Individual participant dataSharing planned: Undecided
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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.
Denise M. Sloan, PhD principal investigator
VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
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 Disclosure in people with Post-Traumatic Stress Disorder, run by Boston 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 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 28 Feb 2018. 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?
Clinician-Administered Posttraumatic Stress Disorder Scale (time frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups). 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 NCT00862498, 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 28 Feb 2018.