NCT01773811

Brief Summary

The current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

January 18, 2013

Last Update Submit

May 14, 2014

Conditions

Keywords

Posttraumatic Stress Disorder (PTSD)Narrative Writing

Outcome Measures

Primary Outcomes (1)

  • Level of PTSD symptoms as measured by the Clinician Administered PTSD Scale

    1 month after final writing session

Secondary Outcomes (1)

  • Physical health

    1 month after final writing session

Study Arms (3)

Control

NO INTERVENTION

Individuals will write objectively about the events of their day.

Narrative Writing: Trauma-Assigned

EXPERIMENTAL

Trauma-assigned: Individuals will write about their most traumatic life experience and be instructed to continue to think about their writing topic in the weeks following writing.

Behavioral: Narrative Writing: Trauma-Assigned

Narrative Writing: Trauma-Spontaneous

ACTIVE COMPARATOR

Individuals will write about their most traumatic life experience but will not be given further instructions for processing. Any additional processing about their writing topic in the weeks following writing will be considered spontaneous.

Behavioral: Narrative Writing: Trauma-Spontaneous

Interventions

Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the assigned group will be given instructions and weekly reminders to continue to think about their most traumatic event.

Narrative Writing: Trauma-Assigned

Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the spontaneous group will be given no further instructions.

Narrative Writing: Trauma-Spontaneous

Eligibility Criteria

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

You may qualify if:

  • Experienced a traumatic life event (DSM-IV-TR Criterion A)
  • Currently experiencing clinically significant levels of PTSD symptoms

You may not qualify if:

  • Currently receiving psychotherapy
  • On medication that is not stable (i.e. medication has been changed within the past 6 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Mississippi

University, Mississippi, 38677, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Tom Lombardo, PhD

    University of Mississippi, Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

February 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations