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

Posttraumatic Stress Disorders Clinical Trial

Official title:

Examining Potential Moderators and Mediators in the Expressive Writing Intervention: The Role of Affect Regulation and Self-presentation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00831727
• Other study ID #: 23614
• Secondary ID: SSHRC 767-2007-2
• Status: Active, not recruiting
• Phase: N/A
• First received: January 28, 2009
• Last updated: April 14, 2010
• Start date: February 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2010
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Expressive Writing
Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing
• Control
Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days

Locations

Country	Name	City	State
Canada	Ontario Institute for Studies in Education of the University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posttraumatic Stress Diagnostic Scale		Initial session; One month follow-up	No
Secondary	Difficulties in Emotion Regulation Scale		Initial session; One month follow-up	No
Secondary	Pennebaker Inventory of Limbic Languidness		Initial session; One month follow-up	No
Secondary	Beck Depression Inventory, Second Edition		Initial session; One month follow-up	Yes