Program for Alleviating and Resolving Trauma and Stress 1

Completed · Not applicable

Conditions studied: Post-traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT04713501

Run by

Cambridge Health Alliance

People needed

15

Starts

2020-12-22

Expected to finish

2021-07-31

Last updated by the study team

2021-10-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cambridge Health Alliance — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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