Cambridge Health Alliance
Cambridge, Massachusetts, 02141, United States
NCT Number: NCT04713501
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Cambridge, Massachusetts, 02141, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To qualify for inclusion in this study, a prospective participant must:
Exclusion criteria
Any and all of the following criteria will exclude a prospective participant from the study:
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.
Time frame: 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.
Time frame: Week 16
A secondary aim is to evaluate feasibility by demonstrating at least 50% of participants are retained in the program at 16 weeks..
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Week 16
The DERS is a 36-item self-report scale designed to assess emotional dysregulation. The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses ("When I'm upset, I become embarrassed for feeling that way"), difficulties engaging in goal directed behavior ("When I'm upset, I have difficulty thinking about anything else"), impulse control difficulties ("When I'm upset, I lose control over my behaviors"), lack of emotional awareness ("When I'm upset, I take time to figure out what I'm really feeling (reverse-scored)", limited access to emotion regulation strategies ("When I'm upset, it takes me a long time to feel better"), and lack of emotional clarity ("I have no idea how I am feeling").
Time frame: Week 16
The Pictorial Representation of Illness and Self Measure (PRISM) is a visual method to assess the global burden of illness, measuring the participant's "self-trauma fusion". Using the iPrism Lite ipad app, the user places a disk representing the illness in relation to a disk representing the self.
Time frame: Week 16
The MDI is a 30-item self-report inventory measuring frequency of dissociative symptoms (e.g., depersonalization, derealization, emotional constriction, identity dissociation, etc.)
Time frame: 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 will assess depression severity with the CAT-DI.
Time frame: Week 16
The SCS-SF is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. This scale evaluates 6 different aspects of self-compassion: Self-Kindness (e.g., ''I try to be understanding and patient toward those aspects of my personality I don't like''), Self-Judgment (e.g., ''I'm disapproving and judgmental about my own flaws and inadequacies''), Common Humanity (e.g., ''I try to see my failings as part of the human condition''), Isolation (e.g., ''When I feel inadequate in some way, I try to remind myself that feelings of inadequacy are shared by most people"), Mindfulness (e.g., ''When something painful happens I try to take a balanced view of the situation''), and Over-Identification (e.g., ''When I'm feeling down I tend to obsess and fixate on everything that's wrong.''). The scale is scored on a 5-point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored.
Time frame: Week 16
The PSS-4 uses 4 items to measure the degree to which situations in life are stressful, evaluating how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5-point Likert scale from 0 (Never) to 4 (Very often).
Time frame: Week 16
The TMS is a 13-item scale evaluating mindfulness factors of curiosity and decentering.
Time frame: Week 16
The MAIA-2 is a 37-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness (e.g., body trusting).
Cambridge Health Alliance
Other
Program for Alleviating and Resolving Trauma and Stress Study (Stage 1 Pilot)
Acronym: PARTS1
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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