The PARTS Study: A Pilot Randomized Controlled Trial of the PARTS Intensive IFS Program vs. a Nature-based Stress Reduction Program for PTSD in a Community Mental Health Clinic
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- Cambridge Health Alliance
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Change from Baseline CAPS-5 at 16 Weeks
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This pilot RCT will test the preliminary efficacy of an intensive group model of Internal Family Systems (IFS) called the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) attention placebo control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, the effects of the interventions on self-reported PTSD symptoms, disassociation, and disturbances of self-organization (DSO), as well as mechanisms of emotion regulation, decentering and self-compassion will be secondary outcomes.
Detailed Description
The investigators will conduct a pilot RCT to test the preliminary efficacy of the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). Secondary clinical outcomes include the effects of the intervention on self-reported PTSD symptoms (PCL-5; CAT-PTSD), disassociation (MDI), and disturbances of self-organization (ITQ). Secondary mechanistic outcomes include emotion regulation (DERS), self-compassion (SCS-SF), and decentering (EQ-D) . Exploratory aims of the study are to investigate the effects on depression (CAT-DI), mental health (CAT-MH scales), self-trauma fusion (PRISM-D), perceived stress (PSS), internalized stigma (ISMI), and interoception (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
Director, Center for Mindfulness and Compassion and Director of Addiction Research
Cambridge Health Alliance
Eligibility Criteria
Inclusion Criteria
- •Be able to bill insurance for 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 score \>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
- •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 any other reason);
- •Current participation in another experimental research study;
- •Expected medical hospitalization in six months from the date of enrollment;
- •Expected incarceration in six months from the date of enrollment;
- •Individuals who are pregnant with a due date within 26 weeks after study consent;
- •Insufficient level of severity of PTSD symptoms: CAPS-5 SEV2 Total score less than 26; PTSD score of less than 31 on the PTSD Checklist for DSM-V (PCL-5)8 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 \> 30 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-MH5 (\>70)
- •Acute suicidality or self-injurious behavior
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 16 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
- Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks(Week 16)
- Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks(Week 16)
- Change from Baseline Decentering (EQ-D) at 16 weeks(Week 16)
- Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks(Week 16)
- Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks(Week 16)
- Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks(Week 16)
- Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks(Week 16)