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Program for Alleviating and Resolving Trauma and Stress 2 (PARTS2)

Primary Purpose

Post-traumatic Stress Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PARTS Program

NBSR-T Program

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, stress, RCT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Be able to bill insurance for individual psychotherapy at CHA;
Be a current patient of CHA primary care, behavioral health care or CHA MINDWell;
Have a current diagnosis of PTSD OR a CAT-MH PTSD score >58;
Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent;
Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online videoconference groups;
Must be available and willing to attend the scheduled online group sessions for 16 weeks; and must be available and willing to complete the online computerized assessments and phone interviews.

Exclusion Criteria:

Inability to complete an informed consent assessment AND/OR inability to complete baseline study assessment procedures (due to cognitive deficit, non-proficiency in English literacy, or any other reason);
Current participation in another experimental research study;
Expected medical hospitalization in six months from the date of enrollment;
Expected incarceration in six months from the date of enrollment;
Individuals who are pregnant with a due date within 26 weeks after study consent;
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)8 at screening visit;
Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria):
Past year history of a psychotic disorder or clinician confirmed active psychosis (Severe level of psychosis on PSY-S-CAT > 30 will trigger the requirement of a clinical assessment prior to participation in the program)
Bipolar I disorder history or severe level of mania on CAT-MH5 (>70)
Acute suicidality or self-injurious behavior
Severe depression, indicated by CAT-DI > 755,65
Acute homicidality with plan and/or intent;
Hospitalization for suicide attempt or self-harm within three months of the enrollment period;
Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or
Moderate or severe Substance Use Disorder. In addition, use of or positive toxicology for illicit drugs (e.g., cocaine, opioids, etc.) or non-prescribed controlled medications (i.e., opioids, stimulants, or benzodiazepines) in the past 3 months.

Sites / Locations

Cambridge Health Alliance Center for Mindfulness and CompassionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PARTS

NBSR-T

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline CAPS-5 at 16 Weeks

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 16 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

Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks

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 Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks

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.

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

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.

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

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").

Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks

The MDI is a 30-item self-report inventory measuring frequency of dissociative symptoms (e.g., depersonalization, derealization, emotional constriction, identity dissociation, etc.)

Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks

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.

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

The EQ-D is an 11-item scale representing the Decentering items of the Experiences Questionnaire.

Full Information

NCT ID

NCT05095428

First Posted

October 5, 2021

Last Updated

December 6, 2022

Sponsor

Cambridge Health Alliance

Collaborators

Foundation for Self Leadership

1. Study Identification

Unique Protocol Identification Number

NCT05095428

Brief Title

Program for Alleviating and Resolving Trauma and Stress 2

Acronym

PARTS2

Official Title

The PARTS Study: A Pilot Randomized Controlled Trial of the PARTS Intensive IFS Program vs. a Nature-based Stress Reduction Program for PTSD in a Community Mental Health Clinic

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 28, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cambridge Health Alliance

Collaborators

Foundation for Self Leadership

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This pilot RCT will test the preliminary efficacy of an intensive group model of Internal Family Systems (IFS) called the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) attention placebo control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). In addition, the effects of the interventions on self-reported PTSD symptoms, disassociation, and disturbances of self-organization (DSO), as well as mechanisms of emotion regulation, decentering and self-compassion will be secondary outcomes.

Detailed Description

The investigators will conduct a pilot RCT to test the preliminary efficacy of the Program for Alleviating and Resolving Trauma and Stress (PARTS) compared with a Nature-Based Stress Reduction for Trauma Survivors (NBSR-T) control group at reducing PTSD symptom severity measured by Clinician-Administered PTSD Scale (CAPS-5). Secondary clinical outcomes include the effects of the intervention on self-reported PTSD symptoms (PCL-5; CAT-PTSD), disassociation (MDI), and disturbances of self-organization (ITQ). Secondary mechanistic outcomes include emotion regulation (DERS), self-compassion (SCS-SF), and decentering (EQ-D) . Exploratory aims of the study are to investigate the effects on depression (CAT-DI), mental health (CAT-MH scales), self-trauma fusion (PRISM-D), perceived stress (PSS), internalized stigma (ISMI), and interoception (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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-traumatic Stress Disorder

Keywords

PTSD, stress, RCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants will be unaware of study hypotheses or arms and will be told the study is for stress reduction among people with trauma/PTSD. The staff member responsible for final determination of study eligibility will be blinded to the randomization sequence. The Data Analyst and methodologist will be blinded to participant identity prior to and during randomization and analysis. The PI will be blinded to participant randomization status for the duration of the study. Medical Review Officer: The MRO will not be blinded and will be responsible for advising on adverse events. Independent Evaluators conducting the CAPS-5 assessments will be blinded to the participants' randomization status. To protect this, independent CAPS-5 evaluators will be located separately from group leaders and therapists. In the event of an unintentional unblinding, a new rater will be assigned to assess the relevant participant(s).

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PARTS

Arm Type

Experimental

Arm Description

Arm Title

NBSR-T

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PARTS Program

Intervention Description

The 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.

Intervention Type

Behavioral

Intervention Name(s)

NBSR-T Program

Intervention Description

The 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.

Primary Outcome Measure Information:

Title

Change from Baseline CAPS-5 at 16 Weeks

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Change from Baseline Self-reported PTSD symptoms (PCL-5) at 16 Weeks

Description

Time Frame

Week 16

Title

Change from Baseline Self-reported PTSD symptoms (CAT-PTSD) at 16 Weeks

Description

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

Title

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

Description

Time Frame

Week 16

Title

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

Description

Time Frame

Week 16

Title

Change from Baseline Multiscale Dissociation Inventory (MDI) at 16 Weeks

Description

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

Title

Change from Baseline Self-Compassion Scale (SCS-SF) at 16 Weeks

Description

Time Frame

Week 16

Title

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

Description

The EQ-D is an 11-item scale representing the Decentering items of the Experiences Questionnaire.

Time Frame

Week 16

Other Pre-specified Outcome Measures:

Title

Change from Baseline Pictorial Representation of Illness and Self Measure Drawaing (PRISM-D) --Trauma at 16 Weeks

Description

drawing version of the PRISM, a virtual visual method to assess the global burden of illness.

Time Frame

Week 16

Title

Change from Baseline Depression (CAT-DI) at 16 Weeks

Description

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

Title

Change from Baseline Perceived Stress Scale (PSS-4) at 16 Weeks

Description

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

Title

Change from Baseline Multidimensional Assessment of Interoceptive Awareness (MAIA-2) at 16 Weeks

Description

The MAIA-2 is a 37-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness (e.g., body trusting).

Time Frame

Week 16

Title

Change from Baseline Internalized Stigma of Mental Illness (ISMI) at 16 weeks

Description

The ISMI is a 29-item measure with five subscales (e.g., alienation, stereotype endorsement, perceived discrimination, etc.)

Time Frame

Week 16

Title

Change from Baseline CAT-Anx at 16 weeks

Description

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 assessed with scales for CAT-Anxiety.

Time Frame

Week 16

Title

Change from Baseline CAT-Mania/Hypomania at 16 weeks

Description

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 assessed with scales for CAT-M/HM.

Time Frame

Week 16

Title

Change from Baseline CAT-SUD at 16 weeks

Description

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 assessed with scales for CAT-SUD.

Time Frame

Week 16

Title

Change from Baseline CAT-Psychosis at 16 weeks

Description

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 assessed with scales for CAT-PSY.

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be able to bill insurance for individual psychotherapy at CHA; Be a current patient of CHA primary care, behavioral health care or CHA MINDWell; Have a current diagnosis of PTSD OR a CAT-MH PTSD score >58; Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent; Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online videoconference groups; Must be available and willing to attend the scheduled online group sessions for 16 weeks; and must be available and willing to complete the online computerized assessments and phone interviews. Exclusion Criteria: Inability to complete an informed consent assessment AND/OR inability to complete baseline study assessment procedures (due to cognitive deficit, non-proficiency in English literacy, or any other reason); Current participation in another experimental research study; Expected medical hospitalization in six months from the date of enrollment; Expected incarceration in six months from the date of enrollment; Individuals who are pregnant with a due date within 26 weeks after study consent; 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)8 at screening visit; Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria): Past year history of a psychotic disorder or clinician confirmed active psychosis (Severe level of psychosis on PSY-S-CAT > 30 will trigger the requirement of a clinical assessment prior to participation in the program) Bipolar I disorder history or severe level of mania on CAT-MH5 (>70) Acute suicidality or self-injurious behavior Severe depression, indicated by CAT-DI > 755,65 Acute homicidality with plan and/or intent; Hospitalization for suicide attempt or self-harm within three months of the enrollment period; Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or Moderate or severe Substance Use Disorder. In addition, use of or positive toxicology for illicit drugs (e.g., cocaine, opioids, etc.) or non-prescribed controlled medications (i.e., opioids, stimulants, or benzodiazepines) in the past 3 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Comeau, M.A.

Phone

617-806-8735

acomeau@challiance.org

First Name & Middle Initial & Last Name or Official Title & Degree

Lydia Smith, B.A.

Phone

7818506592

lysmith@challiance.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zev Schuman-Olivier, M.D.

Organizational Affiliation

Center for Mindfulness and Compassion

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cambridge Health Alliance Center for Mindfulness and Compassion

City

Somerville

State/Province

Massachusetts

ZIP/Postal Code

02143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zev D Schuman-Olivier, MD

Phone

617-591-6132

zschuman@cha.harvard.edu

First Name & Middle Initial & Last Name & Degree

Alexandra Comeau, MA

Phone

617-806-8735

acomeau@challiance.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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30178492

Citation

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