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Behavioral Intervention

PARTS vs NBSR-T Programs for PTSD (PARTS2 Trial)

N/A

Waitlist Available

Led By Zev Schuman-Olivier, M.D.

Research Sponsored by Cambridge Health Alliance

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a current diagnosis of PTSD OR a CAT-MH PTSD score >58

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

PARTS2 Trial Summary

This trial will test if an intensive group model of Internal Family Systems (IFS) called the Program for Alleviating and Resolving Trauma and Stress (PARTS) is more effective than a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) attention placebo control group at reducing PTSD symptom severity.

Who is the study for?

This trial is for current patients of CHA with PTSD or a CAT-MH PTSD score >58, who can read and understand English well enough to consent and participate. They must be able to bill insurance for psychotherapy, attend online sessions for 16 weeks, complete assessments, have internet access and not be involved in other experimental studies.Check my eligibility

What is being tested?

The PARTS Program—an intensive group therapy based on Internal Family Systems—is being tested against the NBSR-T control group. The main goal is to see if PARTS reduces PTSD symptoms more effectively than NBSR-T using various psychological measures.See study design

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort or distress as they engage with traumatic memories during therapy.

PARTS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD or scored over 58 on the CAT-MH PTSD test.

PARTS2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline CAPS-5 at 16 Weeks

Secondary outcome measures

Change from Baseline Decentering (EQ-D) at 16 weeks

Change from Baseline Difficulties in Emotion Regulation (DERS) Scale at 16 Weeks

Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks

+4 more

Other outcome measures

Change from Baseline CAT-Anx at 16 weeks

Change from Baseline CAT-Mania/Hypomania at 16 weeks

Change from Baseline CAT-Psychosis at 16 weeks

+6 more

PARTS2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PARTSExperimental Treatment1 Intervention

The Program for Alleviating and Resolving Trauma and Stress (PARTS) Program is a 16-week group intervention model of Internal Family Systems (IFS), with 8 individual IFS clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.

Group II: NBSR-TActive Control1 Intervention

The Nature Based Stress Reduction for Trauma Survivors (NBSR-T) Program is a 16-week nature-based group intervention model, with 8 individual non-IFS clinical sessions on a biweekly basis, developed as an attention placebo control for individuals diagnosed with PTSD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PARTS Program

2020

N/A

~20

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cambridge Health AllianceLead Sponsor

57 Previous Clinical Trials

20,470 Total Patients Enrolled

Foundation for Self LeadershipUNKNOWN

3 Previous Clinical Trials

69 Total Patients Enrolled

Zev Schuman-Olivier, M.D.Principal InvestigatorCenter for Mindfulness and Compassion

Media Library

PARTS Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05095428 — N/A

Post-Traumatic Stress Disorder Research Study Groups: PARTS, NBSR-T

Post-Traumatic Stress Disorder Clinical Trial 2023: PARTS Program Highlights & Side Effects. Trial Name: NCT05095428 — N/A

PARTS Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095428 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently enlisting participants?

"Clinicaltrials.gov states that this experiment, which was first introduced on April 1st 2022 and recently modified on March 23rd 2022, is no longer accepting applicants. Fortunately, 343 other trials are actively searching for participants."

Answered by AI

Is this research project accepting volunteers that exceed the age of twenty-five?

"Candidates that meet the criteria of being between 18 and 75 years old are welcomed to participate in this experiment."

Answered by AI

Does this clinical trial have any open enrollment opportunities?

"This clinical trial is looking to enrol 84 individuals, aged 18-75 years old, who are suffering from post traumatic stress disorder or a high score on the CAT-MH PTSD. Eligible participants must have access to both an internet connection and appropriate data capacity device in order to participate online. Furthermore, they need to be able to bill their insurance for psychotherapy at CHA as well as being current patients of either primary care or behavioral health care there. Finally, volunteers should be available and willing attend 16 weeks of scheduled group sessions alongside completing assigned assessment tasks via computerized systems and over the phone interviews."

Answered by AI