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Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00475241
First received: May 17, 2007
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: October 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Combat Disorders
Posttraumatic Stress Disorder
Interventions: Behavioral: Prolonged Exposure therapy for PTSD
Behavioral: Present centered therapy for PTSD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prolonged Exposure

Prolonged exposure therapy for PTSD

Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD

Present Centered Therapy

Present centered therapy for PTSD

Present centered therapy for PTSD: present focused coping and problem solving for PTSD


Participant Flow:   Overall Study
    Prolonged Exposure     Present Centered Therapy  
STARTED     18     18  
COMPLETED     11     15  
NOT COMPLETED     7     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
none

Reporting Groups
  Description
Prolonged Exposure

Prolonged exposure therapy for PTSD

Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD

Present Centered Therapy

Present centered therapy for PTSD

Present centered therapy for PTSD: present focused coping and problem solving for PTSD

Total Total of all reporting groups

Baseline Measures
    Prolonged Exposure     Present Centered Therapy     Total  
Number of Participants  
[units: participants]
  11     15     26  
Age  
[units: years]
Mean ± Standard Deviation
  29.8  ± 6.5     32.9  ± 7.2     31.6  ± 7.0  
Gender  
[units: participants]
     
Female     2     0     2  
Male     9     15     24  
Region of Enrollment  
[units: participants]
     
United States     11     15     26  
CAPS [1]
[units: units on a scale]
Mean ± Standard Deviation
  79.2  ± 12.1     77.4  ± 12.1     78.2  ± 11.9  
[1] Clinician Adminstered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136. Higher scores represent more severe symptoms.



  Outcome Measures

1.  Primary:   Clinician Administered PTSD Scale (Pre & Posttreatment)   [ Time Frame: PostTreatment (Week 12) ]

2.  Secondary:   Psychophysiological Reactivity Will be Assessed Using a Biopac MP-100 Physiology Recording System for Measurement of Heart Rate (Electrocardiography, ECG), Skin Conductance, Respiration, and End-tidal pCO2 (Pre, Mid, Posttreatment, 3 and 6 mo FU).   [ Time Frame: pre, mid, post, 3 and 6 mo FU ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   HPA Axis Reactivity Will be Assessed With Collection of Salivary Cortisol at Each Major Assessment. Cortisol Response to Awakening, Our Measure of General Stress Reactivity, Will be Calculated.   [ Time Frame: pre, mid, post, 3 and 6 mo FU ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   All of Below Measures Are Taken at the Major Assessment Points.- Beck Depression Inventory-II- Depression Anxiety Stress Scale- Posttraumatic Cognitions Inventory- Client Satisfaction Questionnaire   [ Time Frame: pre, mid, post, 3 and 6 mo FU ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sheila A.M. Rauch
Organization: VA Ann Arbor Healthcare System
phone: 734-845-3545
e-mail: sherauch@med.umich.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00475241     History of Changes
Other Study ID Numbers: CDA-2-010-06F
Study First Received: May 17, 2007
Results First Received: October 27, 2014
Last Updated: November 3, 2014
Health Authority: United States: Federal Government