What side effects are associated with this type of intervention?

Common treatments for PTSD include trauma-focused cognitive behavioral therapy (CBT), exposure therapy, and medications such as SSRIs (e.g., sertraline). Trauma-focused therapies like CBT and exposure therapy generally have fewer physical side effects but can cause emotional distress as patients confront traumatic memories. SSRIs may cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. While specific side effects for the Internal Family Systems (IFS) model are not detailed, psychotherapeutic approaches generally focus on emotional and psychological processing, which can sometimes lead to temporary increases in anxiety or distress as patients work through trauma-related issues.

What other types of research exist?

Promising novel alternatives to PARTS for PTSD patients include: 1) Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP), which integrates mindfulness with trauma-focused therapy to address PTSD and substance use disorder; 2) Cognitive Behavioral Internet-based Self-Help Program (SHTC), which uses cognitive-behavioral modules to address traumatic event-related symptoms; 3) Cognitive Processing Therapy (CPT), which has shown significant improvements in psychosocial functioning for PTSD patients; and 4) Child-Parent Psychotherapy (CPP), which focuses on the parent-child relationship to heal trauma impacts, particularly effective for young children and their parents.

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Behavioral Intervention

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

Q: What prior FDA approvals exist?

The FDA has approved selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine for the treatment of PTSD. These medications help reduce symptoms by modulating serotonin levels in the brain. In contrast, the Internal Family Systems (IFS) model, as studied in the PARTS trial, focuses on addressing and integrating different parts of the self to improve emotional regulation and reduce trauma-related symptoms. While SSRIs target neurochemical imbalances, the IFS model emphasizes psychological and emotional integration, representing a more holistic and therapeutic approach to PTSD treatment.

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

Must not have

Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group

Insufficient level of severity of PTSD symptoms: CAPS-5 SEV2 Total score less than 26; PTSD score of less than 31 on the PTSD Checklist for DSM-V (PCL-5) at the screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy program called PARTS against a nature-based therapy (NBSR-T) to help trauma survivors with PTSD. PARTS helps people manage their internal emotions, while NBSR-T uses nature to reduce stress. The goal is to see which method better reduces PTSD symptoms.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe personality disorder that could disrupt group activities.

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My PTSD symptoms are not severe, scoring below 26 on CAPS-5 and below 31 on PCL-5.

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I have severe depression.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline CAPS-5 at 16 Weeks

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Internal Family Systems (IFS) model, used in the PARTS trial, focuses on addressing and integrating different parts of the self to improve emotional regulation and reduce trauma-related symptoms. This approach helps patients understand and harmonize conflicting internal states, leading to better emotional balance. Cognitive Processing Therapy (CPT) helps patients reframe negative thoughts about the trauma, reducing the emotional impact and improving coping mechanisms. Eye Movement Desensitization and Reprocessing (EMDR) uses guided eye movements to help patients process and integrate traumatic memories, reducing their distress. These treatments are crucial for PTSD patients as they target the underlying cognitive and emotional disruptions caused by trauma, promoting healing and improving overall functioning.

Associations between functioning and PTSD symptom clusters in a dismantling trial of cognitive processing therapy in female interpersonal violence survivors.