Clinical trial NCT05095428: Program for Alleviating and Resolving Trauma and Stress 2
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: PTSD
stress
RCT
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Foundation for Self Leadership
First posted: 2021-10-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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
* Severe depression, indicated by CAT-DI \> 755,65
* 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. In addition, use of or positive toxicology for illicit drugs (e.g., cocaine, opioids, etc.) or non-prescribed controlled medications (i.e., opioids, stimulants, or benzodiazepines) in the past 3 months.

Primary outcomes:
measure: Change from Baseline CAPS-5 at 16 Weeks
timeFrame: Week 16
Secondary outcomes:
measure: Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Decentering (EQ-D) at 16 weeks
timeFrame: Week 16
Other outcomes:
measure: Change from Baseline Pictorial Representation of Illness and Self Measure Drawaing (PRISM-D) --Trauma at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Depression (CAT-DI) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Perceived Stress Scale (PSS-4) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Multidimensional Assessment of Interoceptive Awareness (MAIA-2) at 16 Weeks
timeFrame: Week 16
measure: Change from Baseline Internalized Stigma of Mental Illness (ISMI) at 16 weeks
timeFrame: Week 16
measure: Change from Baseline CAT-Anx at 16 weeks
timeFrame: Week 16
measure: Change from Baseline CAT-Mania/Hypomania at 16 weeks
timeFrame: Week 16
measure: Change from Baseline CAT-SUD at 16 weeks
timeFrame: Week 16
measure: Change from Baseline CAT-Psychosis at 16 weeks
timeFrame: Week 16
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance Center for Mindfulness and Compassion
state: Massachusetts
Study officials:
affiliation: Center for Mindfulness and Compassion
name: Zev Schuman-Olivier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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