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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01263067
Other study ID # 2010-10
Secondary ID
Status Completed
Phase N/A
First received December 15, 2010
Last updated January 13, 2015
Start date October 2010
Est. completion date January 2012

Study information

Verified date January 2015
Source Argosy University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma


Description:

Studies estimate a substantial proportion of MVA survivors, ranging from 9.4% to 59.9%, will develop PTSD following an accident (Blanchard & Hickling, 2004). Based on conservative estimates, past research, indicates that MVA-related PTSD may affect 2.5 to 7 million persons in the United States (Blanchard & Hickling). Furthermore, two seminal epidemiological studies (Kessler et al., 1995; Norris, 1992) that focused on causes of adult PTSD identified MVAs as the most frequent trauma resulting in PTSD. For these reasons, MVA-resultant PTSD represents a significant public health problem that needs not only to be thoroughly understood, but addressed with successful mental health treatment options (Beck & Coffey, 2007; Blanchard & Hickling, 1997, 2004; Bryant et al., 1998; Taylor et al., 1999; Taylor et al., 2001). Although there is empirical literature on the treatment of PTSD following an MVA, additional efficacious and rigorously conducted studies with statistical underpinnings are required to determine the results that can be expected from alternative models of care (Beck & Coffey; Blanchard & Hickling, 1997, 2004).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date January 2012
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Involved in or witnessed a car accident at least 6 months ago.

- PTSD or distress or impairment in important areas of functioning following the car accident

Exclusion Criteria:

- moderate or severe head injury

- current mental health treatment for the MVA-related problem

- severe chronic pre-injury mental health problems

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Lifespan Integration Therapy
LI treatment guides the client to imaginally visit past memories, and then leads her or him forward through time to the present using a concept referred to as the time line. Beginning with the individual's memories from the traumatic experience, the time line first follows memories from the days and weeks after the trauma, then season by season to the present, and is reviewed in ongoing sessions as increasing details of the traumatic event are uncovered.
Lifespan Integration- Control
Participants selected for the control group will be treated 4 weeks following initial contact. Treatment is the same as for the Experimental Group.

Locations

Country Name City State
United States Argosy University Seattle Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Argosy University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pace, P. (2007). Lifespan integration: Connecting ego states through time (fourth ed.). Roslyn, WA: Peggy Pace.

Outcome

Type Measure Description Time frame Safety issue
Primary Clinicians Administered PTSD Scale Participants will be assessed with the CAPS following the final treatment session (up to 5 treatment sessions). following the final treatment session (average of 6 weeks from treatment start date) No
Secondary Personality Assessment Inventory following the final treatment session (average of 6 weeks from treatment start date) No
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