NCT00831727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

January 28, 2009

Last Update Submit

May 10, 2016

Conditions

Keywords

expressive writingtraumainterventionposttraumatic stress

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic Stress Diagnostic Scale

    Initial session; One month follow-up

Secondary Outcomes (3)

  • Difficulties in Emotion Regulation Scale

    Initial session; One month follow-up

  • Pennebaker Inventory of Limbic Languidness

    Initial session; One month follow-up

  • Beck Depression Inventory, Second Edition

    Initial session; One month follow-up

Study Arms (2)

Expressive Writing

EXPERIMENTAL
Behavioral: Expressive Writing

Control

PLACEBO COMPARATOR
Behavioral: Control

Interventions

Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing

Also known as: Emotional writing
Expressive Writing
ControlBEHAVIORAL

Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English
  • Previously experienced trauma (not current or ongoing; excluding bereavement)
  • Currently experiencing trauma-related distress

You may not qualify if:

  • Currently involved in psychotherapy
  • Currently taking psychotropic medications
  • Imminent threat to self or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ontario Institute for Studies in Education of the University of Toronto

Toronto, Ontario, M5S 1V6, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Jeanne C Watson, Ph.D.

    University of Toronto

    STUDY DIRECTOR
  • Justin M Mattina, M.A.

    University of Toronto

    PRINCIPAL INVESTIGATOR
  • Jonathan J Danson, B.A.

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations