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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
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring expressive writing, trauma, intervention, posttraumatic stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 28, 2009
Last Updated
May 10, 2016
Sponsor
University of Toronto
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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

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The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention

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