- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831727
The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1V6
- Ontario Institute for Studies in Education of the University of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fluent in English
- Previously experienced trauma (not current or ongoing; excluding bereavement)
- Currently experiencing trauma-related distress
Exclusion Criteria:
- Currently involved in psychotherapy
- Currently taking psychotropic medications
- Imminent threat to self or others
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
|
Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days
|
|
Experimental: Expressive Writing
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Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Posttraumatic Stress Diagnostic Scale
Time Frame: Initial session; One month follow-up
|
Initial session; One month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difficulties in Emotion Regulation Scale
Time Frame: Initial session; One month follow-up
|
Initial session; One month follow-up
|
|
Pennebaker Inventory of Limbic Languidness
Time Frame: Initial session; One month follow-up
|
Initial session; One month follow-up
|
|
Beck Depression Inventory, Second Edition
Time Frame: Initial session; One month follow-up
|
Initial session; One month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jeanne C Watson, Ph.D., University of Toronto
- Principal Investigator: Justin M Mattina, M.A., University of Toronto
- Principal Investigator: Jonathan J Danson, B.A., University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23614
- SSHRC 767-2007-2210-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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