Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- Cambridge Health Alliance
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change from Baseline CAPS-5 at 16 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This single-arm pilot study (Phase 1) will test the preliminary efficacy of a virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, feasibility, acceptability, and effects on self-report PTSD and disturbances of self-organization (DSO) will be secondary outcomes.
Detailed Description
The investigators will conduct a single-arm pilot study to test the preliminary efficacy of a virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD Scale (CAPS-5). Secondary outcomes include feasibility and acceptability of the PARTS program measured by a Credibility/Expectancy Questionnaire (CEQ) and Treatment Satisfaction Questionnaire. Secondary clinical outcomes include the effects of the PARTS program on self-report PTSD and disturbances of self-organization (DSO). Exploratory aims of the study are to investigate the effects on emotion regulation (DERS), self-trauma fusion (iPRISM-trauma), disassociation (MDI), depression (CAT-DI), self-compassion (SCS-SF), perceived stress (PSS), mindfulness (TMS), and interception (MAIA-2). Additional exploratory outcomes include changes in outcome variables among PTSD subjects with baseline DSO and those without DSO as defined by the International Trauma Questionnaire (ITQ).
Investigators
Zev Schuman Olivier
Assistant Professor, Psychiatry
Cambridge Health Alliance
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from Baseline CAPS-5 at 16 Weeks
Time Frame: Week 16
The primary aim of this study is to examine the preliminary efficacy of a live-online version of the PARTS program on PTSD symptoms measured by reduction in CAPS-5 over 24 weeks. The CAPS-5 is a 30-item questionnaire administered by a trained interviewer and is considered the "gold standard" assessment for PTSD diagnosis and symptoms as defined by the DSM-5. This measure also assesses the duration of symptoms, impact of symptoms on aspects of the participant's life, and if the participant meets criteria for the dissociative subtype of PTSD.
Secondary Outcomes
- Acceptability as assessed by Satisfaction Survey(Week 16)
- Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks(Week 16)
- Retention(Week 16)
- Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks(Week 16)
- Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks(Week 16)