The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention
Primary Purpose
Posttraumatic Stress Disorders
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Expressive Writing
Control
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring expressive writing, trauma, intervention, posttraumatic stress
Eligibility Criteria
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
Sites / Locations
- Ontario Institute for Studies in Education of the University of Toronto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Expressive Writing
Control
Arm Description
Outcomes
Primary Outcome Measures
Posttraumatic Stress Diagnostic Scale
Secondary Outcome Measures
Difficulties in Emotion Regulation Scale
Pennebaker Inventory of Limbic Languidness
Beck Depression Inventory, Second Edition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00831727
Brief Title
The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention
Official Title
Examining Potential Moderators and Mediators in the Expressive Writing Intervention: The Role of Affect Regulation and Self-presentation.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders
Keywords
expressive writing, trauma, intervention, posttraumatic stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expressive Writing
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Other Intervention Name(s)
Emotional writing
Intervention Description
Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days
Primary Outcome Measure Information:
Title
Posttraumatic Stress Diagnostic Scale
Time Frame
Initial session; One month follow-up
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale
Time Frame
Initial session; One month follow-up
Title
Pennebaker Inventory of Limbic Languidness
Time Frame
Initial session; One month follow-up
Title
Beck Depression Inventory, Second Edition
Time Frame
Initial session; One month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne C Watson, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Justin M Mattina, M.A.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan J Danson, B.A.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ontario Institute for Studies in Education of the University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1V6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention
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