PARTS vs NBSR-T Programs for PTSD

(PARTS2 Trial)

Overseen By Lydia Smith, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Must not be taking: Illicit drugs, Non-prescribed meds

Disqualifiers: Psychosis, Bipolar, Suicidality, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

82 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude individuals with moderate or severe Substance Use Disorder and those using illicit drugs or non-prescribed controlled medications in the past 3 months.

What data supports the effectiveness of the NBSR-T and PARTS treatment programs for PTSD?

Research shows that intensive outpatient programs (IOPs) using trauma-focused treatments like Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) therapy are effective for PTSD, with high completion rates and significant symptom reduction. These programs have been shown to improve mental, physical, and social functioning in veterans, suggesting that similar intensive treatments like NBSR-T and PARTS could also be effective. ^{1 2 3 4 5}

What safety data exists for the PARTS vs NBSR-T Programs for PTSD?

There is limited information on the safety of psychotherapy interventions like the PARTS and NBSR-T Programs, as adverse events are not consistently monitored or reported in behavioral health trials. Serious adverse events, such as suicide attempts, are usually tracked, but other side effects, like temporary increases in anxiety, are often not documented. ^{6 7 8 9 10}

Research Team

Zev D Schuman-Olivier, MD

Principal Investigator

Center for Mindfulness and Compassion

Eligibility Criteria

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.

Inclusion Criteria

My insurance can be billed for psychotherapy at CHA.

I can access the internet and have a device for online questionnaires and video calls.

I can attend online sessions for 16 weeks and do online assessments and phone interviews.

Exclusion Criteria

Individuals who are pregnant with a due date within 26 weeks after study consent

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week intervention with either the PARTS or NBSR-T program, including 8 individual sessions on a biweekly basis

16 weeks

Follow-up

Participants are monitored for changes in PTSD symptoms and other secondary outcomes

4 weeks

Treatment Details

Interventions

• NBSR-T Program
• PARTS Program

Trial Overview 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.

Participant Groups

Group I: PARTS Experimental Treatment 1 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-T Active Control 1 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.

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Foundation for Self Leadership

Collaborator

Foundation for Self Leadership

Collaborator

Trials

4

Recruited

150+

Findings from Research

An intensive outpatient program (IOP) for PTSD, offering Prolonged Exposure and Cognitive Processing Therapy three or more times a week, achieved a high completion rate of 87.3% among veterans, indicating strong acceptability.

The IOP demonstrated significant effectiveness, with a large effect size (d = 1.80) in reducing PTSD symptoms, suggesting it is a promising treatment option to enhance engagement and outcomes in PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. Yamokoski, C., Flores, H., Facemire, V., et al.[2023]

In a study of 2,643 veterans receiving treatment for PTSD, 25.9% experienced substantial improvement in symptoms, while 74.1% showed modest improvement, indicating that significant progress is possible in routine clinical practice.

The only strong predictor of substantial improvement was gender, with men having lower odds of achieving significant symptom reduction compared to women, suggesting that treatment approaches may need to be tailored based on gender differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. Shiner, B., Gui, J., Leonard Westgate, C., et al.[2023]

Women veterans and those who started evidence-based psychotherapy (EBP) within a year of seeking mental health care had higher chances of improving their PTSD symptoms, indicating the importance of timely intervention.

Completing at least 8 sessions of EBP and receiving specific therapies like Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) individually were linked to better outcomes, suggesting that both the timing and type of treatment can significantly influence recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with PTSD symptom improvement among Iraq and Afghanistan veterans receiving evidenced-based psychotherapy. Maguen, S., Holder, N., Li, Y., et al.[2021]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

The study presents a consensus framework for assessing the risk of treatment-related suicidal ideation and behavior (SIB) during drug development, addressing a growing concern among health authorities.

This framework considers various factors, including the chemical and pharmacological properties of drugs, patient populations, and regulatory precedents, to better identify and manage SIB risks in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. Muller, PY., Dambach, D., Gemzik, B., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Trauma Management Therapy and Prolonged Exposure Therapy for PTSD in an active duty sample: Design and methodology of a randomized clinical trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Improving mental, physical, and social functioning through participation in a 3-week cognitive processing therapy-based intensive PTSD treatment. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Factors associated with PTSD symptom improvement among Iraq and Afghanistan veterans receiving evidenced-based psychotherapy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. [2022]