Program for Alleviating and Reducing Trauma, Stress, and Substance Use

NCT06207409 | Completed

• 1 other identifier: CHA-IRB-23-24-237
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 (PTSD) and substance use disorders (Program for Alleviating and Reducing Trauma, Stress, and Substance Use, PARTS-SUD). Participants will be in a group for 12 weeks and will be asked to complete survey sessions at baseline and during week 4, 8 and 12.

Conditions

PTSD; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  The primary aim of this study is to examine the feasibility of a live-online version of the PARTS program defined as 70% of participants completing at least 75% (9/12) of groups.

  12 weeks

Secondary Outcomes (3)

• Assessment completion

  12 weeks

• Acceptability

  12 weeks

• Engagement

  12 weeks

Other Outcomes (4)

• PTSD symptom severity

  12 weeks

• Disassociation

  12 weeks

• Disturbance in Self-Organization

  12 weeks

Study Arms (1)

PARTS-SUD Arm

EXPERIMENTAL

The Program for Alleviating and Reducing Trauma, Stress and Substance Use (PARTS-SUD) is a 12-week, Internal Family Systems-based, group intervention with 6 individual clinical sessions on a biweekly basis.

Behavioral: PARTS-SUD

Interventions

PARTS-SUD BEHAVIORAL

The Program for Alleviating and Reducing Trauma, Stress and Substance Use (PARTS-SUD) is a 12-week, Internal Family Systems-based, group intervention with 6 individual clinical sessions on a biweekly basis.

PARTS-SUD Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Foundation for Self Leadership: collaborator

Study Sites (1)

Cambridge Health Alliance

Malden, Massachusetts, 02148, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Mindfulness and Compassion

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: January 17, 2024
• Study Start: September 1, 2023
• Primary Completion: January 10, 2024
• Study Completion: March 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)