Posttraumatic Stress Disorder (PTSD)NCT01773811
Effects of Narrative Writing Duration and Post-writing Processing Instructions on PTSD
A study testing Narrative Writing: Trauma-Assigned and Narrative Writing: Trauma-Spontaneous in people with Posttraumatic Stress Disorder (PTSD), run by University of Mississippi, Oxford at 1 site in United States.
Trial summary
The current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Narrative Writing: Trauma-Assigned and Narrative Writing: Trauma-Spontaneous
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2014
- 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
- Experienced a traumatic life event (DSM-IV-TR Criterion A)
- Currently experiencing clinically significant levels of PTSD symptoms
Who cannot join
- Currently receiving psychotherapy
- On medication that is not stable (i.e. medication has been changed within the past 6 weeks)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Mississippi
University, Mississippi, 38677
About this study
The current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes.
Read the detailed description
Previous research has established the potential for narrative writing about traumatic events to result in positive benefits for physical and psychological health. Research has also provided evidence that written disclosure may reduce post-traumatic stress disorder (PTSD) symptoms. Several mechanisms of action have been proposed to explain why written disclosure produces positive benefits, but all have focused on processes occurring during the writing session. It has been suggested, however, that additional processing may occur after the writing exercises are over, yet no research has studied the influence of this processing on outcomes. The current study proposes to directly measure how processing after participating in written disclosure affects physical and psychological outcomes.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Narrative Writing: Trauma-Assigned, Narrative Writing: Trauma-Spontaneous
- Keywords
- Posttraumatic Stress Disorder (PTSD), Narrative 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.
Narrative Writing: Trauma-AssignedBehavioural
Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the assigned group will be given instructions and weekly reminders to continue to think about their most traumatic event.
Narrative Writing: Trauma-SpontaneousBehavioural
Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the spontaneous group will be given no further instructions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Individuals will write objectively about the events of their day. |
| Narrative Writing: Trauma-Assigned | Experimental | Trauma-assigned: Individuals will write about their most traumatic life experience and be instructed to continue to think about their writing topic in the weeks following writing. Receives: Behavioral: Narrative Writing: Trauma-Assigned |
| Narrative Writing: Trauma-Spontaneous | Active comparator | Individuals will write about their most traumatic life experience but will not be given further instructions for processing. Any additional processing about their writing topic in the weeks following writing will be considered spontaneous. Receives: Behavioral: Narrative Writing: Trauma-Spontaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of PTSD symptoms as measured by the Clinician Administered PTSD Scale
Measured: 1 month after final writing session
Secondary outcomes (1)
Physical health
Physical health as measured by the Pennebaker Inventory of Limibic Languidness (PILL)
Measured: 1 month after final writing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi, Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Lombardo, PhD, Principal investigator, University of Mississippi, Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773811
- Sponsor's protocol ID
- UMO-0004
- Status last verified
- May 2014
- First submitted
- 18 Jan 2013
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Narrative Writing Duration and Post-writing Processing Instructions on PTSD
- ClinicalTrials.gov ID
- NCT01773811
- Acronym / sponsor ID
- UMO-0004
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Posttraumatic Stress Disorder (PTSD), Narrative Writing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Mississippi, OxfordUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Jan 2013 (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 current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes.
Detailed description
Previous research has established the potential for narrative writing about traumatic events to result in positive benefits for physical and psychological health. Research has also provided evidence that written disclosure may reduce post-traumatic stress disorder (PTSD) symptoms. Several mechanisms of action have been proposed to explain why written disclosure produces positive benefits, but all have focused on processes occurring during the writing session. It has been suggested, however, that additional processing may occur after the writing exercises are over, yet no research has studied the influence of this processing on outcomes. The current study proposes to directly measure how processing after participating in written disclosure affects physical and psychological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Individuals will write objectively about the events of their day. |
| Narrative Writing: Trauma-Assigned | Experimental | Behavioral: Narrative Writing: Trauma-AssignedTrauma-assigned: Individuals will write about their most traumatic life experience and be instructed to continue to think about their writing topic in the weeks following writing. |
| Narrative Writing: Trauma-Spontaneous | Active comparator | Behavioral: Narrative Writing: Trauma-SpontaneousIndividuals will write about their most traumatic life experience but will not be given further instructions for processing. Any additional processing about their writing topic in the weeks following writing will be considered spontaneous. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experienced a traumatic life event (DSM-IV-TR Criterion A)
- Currently experiencing clinically significant levels of PTSD symptoms
Key exclusion criteria (2 listed)
- Currently receiving psychotherapy
- On medication that is not stable (i.e. medication has been changed within the past 6 weeks)
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 |
|---|---|---|
| Narrative Writing: Trauma-AssignedIndividuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the assigned group will be given instructions and weekly reminders to continue to think about their most traumatic event. | Behavioural | Narrative Writing: Trauma-Assigned |
| Narrative Writing: Trauma-SpontaneousIndividuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the spontaneous group will be given no further instructions. | Behavioural | Narrative Writing: Trauma-Spontaneous |
Primary outcome
Level of PTSD symptoms as measured by the Clinician Administered PTSD Scale
Time frame: 1 month after final writing session
1 secondary outcome
Physical health
Time frame: 1 month after final writing session
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 15 May 2014.
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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.
Tom Lombardo, PhD principal investigator
University of Mississippi, Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Writing: Trauma-Assigned and Narrative Writing: Trauma-Spontaneous in people with Posttraumatic Stress Disorder (PTSD), run by University of Mississippi, Oxford 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 2 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 15 May 2014. 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?
Level of PTSD symptoms as measured by the Clinician Administered PTSD Scale (time frame: 1 month after final writing session). 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 15 May 2014.