Status:
COMPLETED
Program for Alleviating and Resolving Trauma and Stress 1
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Foundation for Self Leadership
Conditions:
Post-traumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
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 th...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- To qualify for inclusion in this study, a prospective participant must:
- Be 18-70 years of age for the duration of the study;
- Able to bill insurance for group psychotherapy and 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 measure P-CAT\>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
- Any and all of the following criteria will exclude a prospective participant from the study:
- 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 for any other reason);
- Current participation in another experimental research study;
- Expected medical hospitalization in the next six months from enrollment period;
- Expected incarceration in the next six months from enrollment period;
- Individuals who are pregnant with a due date within 26 weeks after study consent;
- Insufficient level of severity of PTSD symptoms: PTSD score of less than 33 on the PTSD Checklist for DSM-V (PCL-5) 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 \> 60 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-M/HM (\>70)
- Acute suicidality or self-injurious behavior
- Severe depression, indicated by CAT-DI PHQ-9 equivalency score \>20
- 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.
Exclusion
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04713501
Start Date
December 22 2020
End Date
July 31 2021
Last Update
October 12 2021
Active Locations (1)
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1
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02141