Posttraumatic Stress DisordersNCT00831727
The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention
A study testing Expressive Writing in people with Posttraumatic Stress Disorders, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of the present study is twofold. First, we will attempt to examine the role that emotion regulation and self-presentation play as potential moderators in the expressive writing paradigm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Expressive Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Nov 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English
- Previously experienced trauma (not current or ongoing; excluding bereavement)
- Currently experiencing trauma-related distress
Who cannot join
- Currently involved in psychotherapy
- Currently taking psychotropic medications
- Imminent threat to self or others
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ontario Institute for Studies in Education of the University of Toronto
Toronto, Ontario, M5S 1V6
About this study
Official title: Examining Potential Moderators and Mediators in the Expressive Writing Intervention: The Role of Affect Regulation and Self-presentation.
The purpose of the present study is twofold. First, we will attempt to examine the role that emotion regulation and self-presentation play as potential moderators in the expressive writing paradigm. We hypothesize that expressive writing participants who demonstrate greater abilities to regulate their emotions at baseline will improve more on our outcome measures. We also hypothesize that those expressive writing participants who demonstrate higher levels of self-presentation at baseline will improve less on our outcome measures.
The second aim of the study has two related objectives. First, we will attempt to investigate whether the expressive writing intervention can increase and enhance an individual's emotion regulation abilities. Related to this, we will then go on to examine whether emotion regulation can be looked at as a potential mechanism of action in the expressive writing procedure. Related to these two objectives, we hypothesize that in comparison to the control group, participants in the expressive writing condition will show increases in their ability to regulate their emotions from baseline to four week follow up. Moreover, we predict that greater gains in emotion regulation abilities for the expressive writing participants will be significantly related to greater gains in outcome measures.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Expressive Writing, Control
- Keywords
- expressive writing, trauma, intervention, posttraumatic stress
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
Also called Emotional writing
Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing
ControlBehavioural
Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Expressive Writing | Experimental | Not described Receives: Behavioral: Expressive Writing |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Diagnostic Scale
Measured: Initial session; One month follow-up
Secondary outcomes (3)
Difficulties in Emotion Regulation Scale
Measured: Initial session; One month follow-up
Pennebaker Inventory of Limbic Languidness
Measured: Initial session; One month follow-up
Beck Depression Inventory, Second Edition
Measured: Initial session; One month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Mattina, University of Toronto
- Investigators
- Jeanne C Watson, Ph.D., Study director, University of TorontoJustin M Mattina, M.A., Principal investigator, University of TorontoJonathan J Danson, B.A., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831727
- Sponsor's protocol ID
- 23614
- Other IDs
- SSHRC 767-2007-2210-4
- Status last verified
- May 2016
- First submitted
- 28 Jan 2009
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Potential Moderators and Mediators in the Expressive Writing Intervention: The Role of Affect Regulation and Self-presentation.
- ClinicalTrials.gov ID
- NCT00831727
- Acronym / sponsor ID
- 23614
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- expressive writing, trauma, intervention, posttraumatic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jan 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.
The purpose of the present study is twofold. First, we will attempt to examine the role that emotion regulation and self-presentation play as potential moderators in the expressive writing paradigm. We hypothesize that expressive writing participants who demonstrate greater abilities to regulate their emotions at baseline will improve more on our outcome measures. We also hypothesize that those expressive writing participants who demonstrate higher levels of self-presentation at baseline will improve less on our outcome measures.
The second aim of the study has two related objectives. First, we will attempt to investigate whether the expressive writing intervention can increase and enhance an individual's emotion regulation abilities. Related to this, we will then go on to examine whether emotion regulation can be looked at as a potential mechanism of action in the expressive writing procedure. Related to these two objectives, we hypothesize that in comparison to the control group, participants in the expressive writing condition will show increases in their ability to regulate their emotions from baseline to four week follow up. Moreover, we predict that greater gains in emotion regulation abilities for the expressive writing participants will be significantly related to greater gains in outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing | Experimental | Behavioral: Expressive Writing |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent in English
- Previously experienced trauma (not current or ongoing; excluding bereavement)
- Currently experiencing trauma-related distress
Key exclusion criteria (3 listed)
- Currently involved in psychotherapy
- Currently taking psychotropic medications
- Imminent threat to self or others
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 |
|---|---|---|
| Expressive WritingAlso: Emotional writingParticipants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing | Behavioural | Expressive Writing |
| ControlParticipants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days | Behavioural | Control |
Primary outcome
Posttraumatic Stress Diagnostic Scale
Time frame: Initial session; One month follow-up
3 secondary outcomes
Difficulties in Emotion Regulation Scale
Time frame: Initial session; One month follow-up
Pennebaker Inventory of Limbic Languidness
Time frame: Initial session; One month follow-up
Beck Depression Inventory, Second Edition
Time frame: Initial session; One month follow-up
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 12 May 2016.
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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.
Jeanne C Watson, Ph.D. study director
University of Toronto
Justin M Mattina, M.A. principal investigator
University of Toronto
Jonathan J Danson, B.A. principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing in people with Posttraumatic Stress Disorders, run by University of Toronto at 1 site in Canada.
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 3 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 12 May 2016. 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 Canada. 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?
Posttraumatic Stress Diagnostic Scale (time frame: Initial session; One month follow-up). 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 12 May 2016.