Posttraumatic Stress DisorderNCT01263067
Lifespan Integration for Posttraumatic Stress Disorder From an Auto Accident
A study testing Lifespan Integration Therapy in people with Posttraumatic Stress Disorder, run by Argosy University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Lifespan Integration Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- moderate or severe head injury
- current mental health treatment for the MVA-related problem
- severe chronic pre-injury mental health problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Argosy University Seattle
Seattle, Washington, 98103
About this study
Official title: Lifespan Integration Therapy for Posttraumatic Stress Disorder of Adults Involved in an Auto Accident
The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma
Read the detailed 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).
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Lifespan Integration Therapy, Lifespan Integration- Control
- Keywords
- Posttraumatic Stress Disorder, PTSD, Car Accident, Auto Accident, Lifespan Integration
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifespan Integration TherapyBehavioural
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- ControlBehavioural
Participants selected for the control group will be treated 4 weeks following initial contact. Treatment is the same as for the Experimental Group.
| Study group | Role | What they receive |
|---|---|---|
| Lifespan Integration Therapy (LI) | Experimental | Not described Receives: Behavioral: Lifespan Integration Therapy |
| Waitlist Control- Lifespan Integration | Active comparator | Not described Receives: Behavioral: Lifespan Integration- Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicians Administered PTSD Scale
Participants will be assessed with the CAPS following the final treatment session (up to 5 treatment sessions).
Measured: following the final treatment session (average of 6 weeks from treatment start date)
Secondary outcomes (1)
Personality Assessment Inventory
Measured: following the final treatment session (average of 6 weeks from treatment start date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argosy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elana Rosencrantz, Argosy University
- Investigators
- Frances Parks, PhD, Study chair, Argosy University Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263067
- Sponsor's protocol ID
- 2010-10
- Status last verified
- Jan 2015
- First submitted
- 15 Dec 2010
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pace, P. (2007). Lifespan integration: Connecting ego states through time (fourth ed.). Roslyn, WA: Peggy Pace.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifespan Integration Therapy for Posttraumatic Stress Disorder of Adults Involved in an Auto Accident
- ClinicalTrials.gov ID
- NCT01263067
- Acronym / sponsor ID
- 2010-10
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, PTSD, Car Accident, Auto Accident, Lifespan Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Argosy UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifespan Integration Therapy (LI) | Experimental | Behavioral: Lifespan Integration Therapy |
| Waitlist Control- Lifespan Integration | Active comparator | Behavioral: Lifespan Integration- Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- moderate or severe head injury
- current mental health treatment for the MVA-related problem
- severe chronic pre-injury mental health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifespan Integration TherapyLI 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. | Behavioural | Lifespan Integration Therapy (LI) |
| Lifespan Integration- ControlParticipants selected for the control group will be treated 4 weeks following initial contact. Treatment is the same as for the Experimental Group. | Behavioural | Waitlist Control- Lifespan Integration |
Primary outcome
Clinicians Administered PTSD Scale
Time frame: following the final treatment session (average of 6 weeks from treatment start date)
Participants will be assessed with the CAPS following the final treatment session (up to 5 treatment sessions).
1 secondary outcome
Personality Assessment Inventory
Time frame: following the final treatment session (average of 6 weeks from treatment start date)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- BackgroundPace, P. (2007). Lifespan integration: Connecting ego states through time (fourth ed.). Roslyn, WA: Peggy Pace.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Parks, PhD study chair
Argosy University Seattle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifespan Integration Therapy in people with Posttraumatic Stress Disorder, run by Argosy University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicians Administered PTSD Scale (time frame: following the final treatment session (average of 6 weeks from treatment start date)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.