Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT01158001 |
Recruitment Status
:
Completed
First Posted
: July 8, 2010
Last Update Posted
: June 24, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | February 20, 2009 | |||
First Posted Date ICMJE | July 8, 2010 | |||
Last Update Posted Date | June 24, 2015 | |||
Study Start Date ICMJE | May 2009 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Clinician-administered PTSD Scale (CAPS) diagnostic interview [ Time Frame: Pre-treatment, post-treatment (14 weeks after pre-treatment assessment), follow-up six months after post-treatment assessment ] Measure of PTSD diagnosis and severity
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01158001 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder | |||
Official Title ICMJE | Telemedicine for Improved Delivery of Psychosocial Treatments for Post Traumatic Stress Disorder | |||
Brief Summary | The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. The primary aim is to determine feasibility: whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as Prolonged Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic event), to veterans with limited access to care. A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes. | |||
Detailed Description | The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. Specifically, prolonged exposure therapy (PE) was conducted with veterans individually, either in person or via videoconferencing technology. PE is designed to help clients face fears related to a traumatic experience by guiding individuals through exposures to the memory of the event (called "imaginal exposure") and exposures to feared situations (called "in vivo" exposures). The primary aim is to determine the feasibility of whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as PE to veterans with limited access to care. This is measured in part through patient and therapist satisfaction ratings in each condition. A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. This is measured by relative changes in symptoms, primarily in PTSD, depressive symptoms, and anxiety symptoms. A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes across conditions. This includes seven measures of executive functioning. The hypothesis is that poorer performance on these measures may be associated with less improvement on measures of symptom severity. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Prolonged exposure therapy
Twelve sessions (90 minutes each) of prolonged exposure therapy |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
211 | |||
Original Estimated Enrollment ICMJE |
254 | |||
Actual Study Completion Date | September 2012 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01158001 | |||
Other Study ID Numbers ICMJE | 080513 PT074431 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Veterans Medical Research Foundation | |||
Study Sponsor ICMJE | Veterans Medical Research Foundation | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Veterans Medical Research Foundation | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |