Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cambridge Health Alliance
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change from Baseline CAPS-5 at 16 Weeks
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To qualify for inclusion in this study, a prospective participant must:
- •Be 18-70 years of age for the duration of the study;
- •Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
- •Be a current patient of CHA primary care, behavioral health care or CHA MindWell;
- •Have a current diagnosis of PTSD OR a CAT-MH PTSD measure P-CAT>58;
- •Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent;
- •Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online videoconference groups;
- •Must be available and willing to attend the scheduled online group sessions for 16 weeks; and
- •Must be available and willing to complete the online computerized assessments and phone interviews.
Exclusion Criteria
- •Any and all of the following criteria will exclude a prospective participant from the study:
- •Inability to complete an informed consent assessment AND/OR inability to complete baseline study assessment procedures (due to cognitive deficit, non- proficiency in English literacy, or for any other reason);
- •Current participation in another experimental research study;
- •Expected medical hospitalization in the next six months from enrollment period;
- •Expected incarceration in the next six months from enrollment period;
- •Individuals who are pregnant with a due date within 26 weeks after study consent;
- •Insufficient level of severity of PTSD symptoms: PTSD score of less than 33 on the PTSD Checklist for DSM-V (PCL-5) at screening visit;
- •Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria):
- •Past year history of a psychotic disorder or clinician confirmed active psychosis (Severe level of psychosis on PSY-S-CAT > 60 will trigger the requirement of a clinical assessment prior to participation in the program)
- •Bipolar I disorder history or severe level of mania on CAT-M/HM (>70)
- •Acute suicidality or self-injurious behavior
- •Severe depression, indicated by CAT-DI PHQ-9 equivalency score >20
- •Acute homicidality with plan and/or intent;
- •Hospitalization for suicide attempt or self-harm within three months of the enrollment period;
- •Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or
- •Moderate or severe Substance Use Disorder.
Arms & Interventions
PARTS
The PARTS Program is a 16-week group intervention model, with 8 individual clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.
Intervention: PARTS Program (Behavioral)
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)
Investigators
Zev Schuman Olivier
Assistant Professor, Psychiatry
Cambridge Health Alliance