Program for Alleviating and Resolving Trauma and Stress 1

Not Applicable

Completed

• Conditions: Post-traumatic Stress Disorder
• Interventions: Behavioral: PARTS Program

• Registration Number: NCT04713501
• Lead Sponsor: Cambridge Health Alliance

Brief Summary

This single-arm pilot study (Phase 1) will test the preliminary efficacy of a virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, feasibility, acceptability, and effects on self-report PTSD and disturbances of self-organization (DSO) will be secondary outcomes.

Detailed Description

The investigators will conduct a single-arm pilot study to test the preliminary efficacy of a virtually delivered, live-online 16-week group model of Internal Family Systems (IFS) for individuals with PTSD, called the PARTS program, on PTSD symptoms measured by Clinician-Administered PTSD Scale (CAPS-5).

Secondary outcomes include feasibility and acceptability of the PARTS program measured by a Credibility/Expectancy Questionnaire (CEQ) and Treatment Satisfaction Questionnaire. Secondary clinical outcomes include the effects of the PARTS program on self-report PTSD and disturbances of self-organization (DSO). Exploratory aims of the study are to investigate the effects on emotion regulation (DERS), self-trauma fusion (iPRISM-trauma), disassociation (MDI), depression (CAT-DI), self-compassion (SCS-SF), perceived stress (PSS), mindfulness (TMS), and interception (MAIA-2). Additional exploratory outcomes include changes in outcome variables among PTSD subjects with baseline DSO and those without DSO as defined by the International Trauma Questionnaire (ITQ).

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-19
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PARTS	PARTS Program	The PARTS Program is a 16-week group intervention model, with 8 individual clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.

Primary Outcome Measures

Name	Time	Method
Change from Baseline CAPS-5 at 16 Weeks	Week 16	The primary aim of this study is to examine the preliminary efficacy of a live-online version of the PARTS program on PTSD symptoms measured by reduction in CAPS-5 over 24 weeks. The CAPS-5 is a 30-item questionnaire administered by a trained interviewer and is considered the "gold standard" assessment for PTSD diagnosis and symptoms as defined by the DSM-5. This measure also assesses the duration of symptoms, impact of symptoms on aspects of the participant's life, and if the participant meets criteria for the dissociative subtype of PTSD.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks	Week 16	Participants will be sent a link to complete the PTSD Checklist for DSM-5 (PCL-5), which is a self-report measure with 20 items, which is designed to measure PTSD symptom severity over the past month as measured by the DSM-5, in combination with additional diagnostic tools.
Change from Baseline Disturbances of Self Organization -- International Trauma Questionnaire (ITQ-DSO-9) at 16 Weeks	Week 16	The International Trauma Questionnaire (ITQ) is the first instrument designed to capture the ICD-11 PTSD and Complex PTSD (CPTSD) diagnoses. The last 6 items measure DSO symptoms characteristic of ICD-11 CPTSD. Each set of items have 3 severity of impact on functioning questions. The ITQ-DSO-9 includes just the 6 DSO items with 3 severity questions. The ITQ-DSO-9 will be used monthly for self-report of changes in DSO symptoms.
Acceptability as assessed by Satisfaction Survey	Week 16	Participants will complete a satisfaction survey and rate their likeliness to recommend the program to a friend, on a five point Likert-type scale. An average greater than 3 out of 5 represents acceptability.
Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks	Week 16	Participants will be sent a link to complete the CAT-MH (Computer Adaptive Testing for Mental Health) interview on a computer, tablet or phone. This outcome refers to the CAT-PTSD severity score
Retention	Week 16	A secondary aim is to evaluate feasibility by demonstrating at least 50% of participants are retained in the program at 16 weeks..

Trial Locations

Locations (1)

Cambridge Health Alliance; 🇺🇸 Cambridge, Massachusetts, United States