A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
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|ClinicalTrials.gov Identifier: NCT03803332|
Recruitment Status : Suspended (Per IRB COVID-19 guidance on conducting human subjects research.)
First Posted : January 14, 2019
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Exposure Therapy Behavioral: Interpersonal Psychotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma|
|Actual Study Start Date :||March 9, 2020|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||August 2024|
Active Comparator: Exposure Therapy
Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.
Behavioral: Exposure Therapy
Psychotherapy including imaginal and in vivo exposure for PTSD.
Other Name: Prolonged Exposure
Active Comparator: Interpersonal Psychotherapy
Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.
Behavioral: Interpersonal Psychotherapy
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.
- Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment [ Time Frame: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition ]The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
- Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group [ Time Frame: Baseline, 11 weeks ]The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
- Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group [ Time Frame: Baseline, 15 weeks ]The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803332
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10065|
|Principal Investigator:||JoAnn Difede, PhD||Weill Cornell Medicine|