Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy (RCT of TFPP)
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|ClinicalTrials.gov Identifier: NCT03755401|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Other: TFPP Other: TAU||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial of psychosocial interventions|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm|
|Official Title:||A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD|
|Actual Study Start Date :||November 2, 2018|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2022|
TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD
Trauma-Focused Psychodynamic Psychotherapy
Other Name: psychodynamic psychotherapy
Active Comparator: TAU
TAU in this study is treatment for PTSD as currently delivered at the VA
treatment as usual at the VA for PTSD
- Change in PTSD symptoms as per DSM-5 as measured by CAPS-5 [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Low score indicates fewer PTSD symptoms, high score indicates more PTSD symptoms.
- Change in anxiety symptoms as measured by HARS. [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Hamilton Anxiety Rating Scale (HARS). Low score indicates fewer state anxiety symptoms, high score indicates greater state anxiety symptoms
- Change in reflective capacity as measured by RF score. [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Reflective Function Scale (RF). Low score indicates poor ability to reflect on relationships and self, high score, indicates better capacity to reflect on others and self.
- Change in depression symptoms as measured by HDRS. [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Hamilton Depression Rating Scale (HDRS). Low score indicates few depressive symptoms, high score indicates high level of depressive burden (depression)
- Change in mental and physical symptoms as measured by VR-12. [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Veterans RAND 12-Item Health Survey (VR-12). The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
- Change in work and social adjustment as measured by WSAS. [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Work and Social Adjustment Scale (WSAS). Low score indicates good social and work adjustment, high score indicates impairment socially and at work.
- Change in degree of limitation in ability to work as measured by WLQ [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Work Limitations Questionnaire (WLQ). Low score indicates few limitations at work, high score indicates many limitations at work
- Childhood abuse history and trauma with CTQ [ Time Frame: baseline ]Childhood Trauma Questionnaire (CTQ). Several different domains: Emotional Abuse: None=5-8; Low=9-12; Moderate=13-15; Severe=16+ Physical Abuse: None=5-7; Low=8-9; Moderate=10-12; Severe=13+ Sexual Abuse: None=5; Low=6-7; Moderate=8-12; Severe=13+ Emotional Neglect: None=5-9; Low=10-14; Moderate=15-17; Severe=18+ Physical Neglect: None=5-7; Low=8-9; Moderate=10-12; Severe=13+
- Change in adult separation anxiety symptoms as measured by the SCI-SAS [ Time Frame: baseline, 16 weeks (termination), 3 month follow-up ]Separation anxiety-child and adult measure rating scale (SCI-SAS). Separate scores generated for childhood separation anxiety and adult separation anxiety. Low scores indicate few separation anxiety symptoms, high scores indicate large separation anxiety burden.
- Assessment of life events on LEC. [ Time Frame: baseline ]Life Events Checklist (LEC). No composite score-tracks traumatic life events
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): NCT03755401
|Contact: Lauren Wash||(212) 686-7500 ext 3003||Lauren.Wash@va.gov|
|Contact: Cory K Chen, Ph.D.||(212) 686-7500 ext 4002||Cory.Chen@va.gov|
|United States, New York|
|VA New York Harbor Healthcare System - Manhattan Campus||Recruiting|
|New York, New York, United States, 10010|
|Contact: Lauren Wash 212-686-7500 ext 3003 Lauren.Wash@va.gov|
|Contact: Cory K Chen, Ph.D. 212-686-7500 ext 4002 Cory.Chen@va.gov|
|Principal Investigator:||Barbara Milrod, MD||Weill Medical College of Cornell University|