Program for Alleviating and Resolving Trauma and Stress 1 (PARTS1)

Cambridge Health Alliance

Status: Completed

Conditions: Post-traumatic Stress Disorder

Treatments: Behavioral: PARTS Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04713501

CHA-IRB-1158/09/20

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

To qualify for inclusion in this study, a prospective participant must:

1. Be 18-70 years of age for the duration of the study;
2. Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
3. Be a current patient of CHA primary care, behavioral health care or CHA MindWell;
4. Have a current diagnosis of PTSD OR a CAT-MH PTSD measure P-CAT>58;
5. Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent;
6. Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online videoconference groups;
7. Must be available and willing to attend the scheduled online group sessions for 16 weeks; and
8. 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:

1. 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);

2. Current participation in another experimental research study;

3. Expected medical hospitalization in the next six months from enrollment period;

4. Expected incarceration in the next six months from enrollment period;

5. Individuals who are pregnant with a due date within 26 weeks after study consent;

6. 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;

7. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

PARTS

Experimental group

Description:

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.

Treatment:

Behavioral: PARTS Program