Status:
COMPLETED
Program for Alleviating and Reducing Trauma, Stress, and Substance Use
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Foundation for Self Leadership
Conditions:
PTSD
Substance Use Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This single-arm study will test the preliminary efficacy of a virtually delivered, live-online 12-week group model of Internal Family Systems (IFS) for individuals with posttraumatic stress disorder (...
Detailed Description
The investigators have conducted a single arm study of a 16 week PARTS group-based program for PTSD symptoms, which demonstrated large effect reductions on PTSD symptoms, disturbances in self-organiza...
Eligibility Criteria
Inclusion
- Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
- Currently or willing to become a patient of CHA primary care or behavioral health care (as defined by an active CHA EPIC EHR record);
- Have a current diagnosis of PTSD OR a CAT-MH PTSD\>58;
- Have a current diagnosis of a substance use disorder (SUD), positive Alcohol Use Disorders Identification Test AUDIT-C item about 5 or more drinks at once OR positive toxicology for or self-report of illicit drugs in the past year, or current treatment with medications for OUD, including buprenorphine, naltrexone or methadone.
- 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 video conference groups;
- Must be available and willing to attend 10 of 12 scheduled online group sessions for 12 weeks; and
- Must be available and willing to complete the online computerized assessments and phone interviews.
Exclusion
- 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 four months from enrollment period;
- Expected incarceration in the next four months from enrollment period;
- Individuals who are pregnant with a due date within 16 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 will require clinical review to consider eligibility;
- Insufficiently stable housing or internet connection to join at least 10 sessions;
- 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 require clinical assessment prior to participation in the program)
- Bipolar I disorder history or current severe level of mania on CAT-M/H (\>70) will require of a clinical assessment prior to participation in the program
- Acute suicidality with intent will be excluded from the study (Columbia Suicide Rating Scale items 4-6 positive);
- Self-injurious behavior in past three months will require clinical assessment prior to participation in the program;
- Acute homicidality with plan and/or intent;
- Inpatient hospitalization for mental health, substance use, suicide attempt or self-harm within past three months;
- Severe Borderline Personality Disorder or other severe personality disorder with clinical history that would suggest potential disruptions within the group (would require clinical review);
- Inability to join a group without intoxication; and/or
- History of charges for perpetrating intimate partner violence will require clinical assessment prior to participation in the program.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06207409
Start Date
September 1 2023
End Date
March 30 2025
Last Update
June 25 2025
Active Locations (1)
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1
Cambridge Health Alliance
Malden, Massachusetts, United States, 02148