PTSD(PARTS-SUD)NCT06207409
Program for Alleviating and Reducing Trauma, Stress, and Substance Use
A study testing PARTS-SUD in people with PTSD and Substance Use Disorders, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
This single-arm study will test the preliminary efficacy of a virtually delivered, live-online 12-week group model of Internal Family Systems (IFS) for individuals with posttraumatic stress disorder (PTSD) and substance use disorders (Program for Alleviating and Reducing Trauma, Stress, and Substance Use, PARTS-SUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Substance Use Disorders
- What is being tested?
- PARTS-SUD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
- Currently or willing to become a patient of CHA primary care or behavioral health care (as defined by an active CHA EPIC EHR record);
- Have a current diagnosis of PTSD OR a CAT-MH PTSD>58;
- Have a current diagnosis of a substance use disorder (SUD), positive Alcohol Use Disorders Identification Test AUDIT-C item about 5 or more drinks at once OR positive toxicology for or self-report of illicit drugs in the past year, or current treatment with medications for OUD, including buprenorphine, naltrexone or methadone.
- 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 video conference groups;
- Must be available and willing to attend 10 of 12 scheduled online group sessions for 12 weeks; and
- Must be available and willing to complete the online computerized assessments and phone interviews.
Who cannot join
- 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 four months from enrollment period;
- Expected incarceration in the next four months from enrollment period;
- Individuals who are pregnant with a due date within 16 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 will require clinical review to consider eligibility;
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- Insufficiently stable housing or internet connection to join at least 10 sessions;
- 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 require clinical assessment prior to participation in the program)
- Bipolar I disorder history or current severe level of mania on CAT-M/H (>70) will require of a clinical assessment prior to participation in the program
- Acute suicidality with intent will be excluded from the study (Columbia Suicide Rating Scale items 4-6 positive);
- Self-injurious behavior in past three months will require clinical assessment prior to participation in the program;
- Acute homicidality with plan and/or intent;
- Inpatient hospitalization for mental health, substance use, suicide attempt or self-harm within past three months;
- Severe Borderline Personality Disorder or other severe personality disorder with clinical history that would suggest potential disruptions within the group (would require clinical review);
- Inability to join a group without intoxication; and/or
- History of charges for perpetrating intimate partner violence will require clinical assessment prior to participation in the program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Malden, Massachusetts, 02148
About this study
Official title: Program for Alleviating and Reducing Trauma, Stress, and Substance Use (PARTS-SUD)
This single-arm study will test the preliminary efficacy of a virtually delivered, live-online 12-week group model of Internal Family Systems (IFS) for individuals with posttraumatic stress disorder (PTSD) and substance use disorders (Program for Alleviating and Reducing Trauma, Stress, and Substance Use, PARTS-SUD).
Participants will be in a group for 12 weeks and will be asked to complete survey sessions at baseline and during week 4, 8 and 12.
Read the detailed description
The investigators have conducted a single arm study of a 16 week PARTS group-based program for PTSD symptoms, which demonstrated large effect reductions on PTSD symptoms, disturbances in self-organization (DSO), disassociation, emotion dysregulation, suicide risk, anxiety, depression, and increases in decentering and self-compassion. A randomized control trial (RCT) of PARTS groups vs. a control is currently underway and will complete by September 2023. This will be a single-arm feasibility and acceptability pilot study of PARTS for PTSD among patients with substance use disorders.
While 16 weeks is the typical length for PTSD intervention trials, the average treatment length for PTSD-SUD population studies is only 12 weeks given higher risk of attrition with longer treatments for substance use disorder (SUD). Clinically, the group is anticipated to have the most impact on symptoms between weeks and 12 based on the curriculum and practices during those sessions, so the investigators will pilot a 12 week group in this study. Similar to past PARTS studies, participants will also have every other week 50 minute individual counseling sessions. Since IFS and group psychotherapy are established modalities and the pilot trial for PARTS established its evidence as a program with a clinically meaningful effect, this feasibility and acceptability study will primarily focus on the engagement and acceptability of the intervention among patients with PTSD-SUD. Both group and individual sessions will be billed to insurance as per standard Cambridge Health Alliance (CHA) outpatient clinical protocols. To reduce burden from past studies, the investigators will not conduct Clinician-Administered PTSD Scale (CAPS-5) interviews, but solely use self-report measures (PTSD Checklist For DSM-5, PCL-5 and Computerized Adaptive Testing for PTSD, CAT-PTSD), which have a high level of correlation with CAPS-5.
The investigators aim to have 10-12 participants allocated to start the program aiming for 70% of completion of the study intervention (defined as 75% completion of sessions) and 70% completion of week 12 assessments with adequate intervention acceptability. After participants have completed all baseline screenings, assessments and the informed consent procedure, a study staff member will contact them to begin the virtual program delivered in real time over the secure, HIPAA compliant video conference (e.g. Google Meets, Zoom).
Surveys, Procedures and Duration The duration of the study period is 12 weeks (see Figure 1). Participants will complete screening surveys and a long survey battery at baseline; survey batteries (approximately 62 minutes) at study Week 4, 8 and 12; and weekly substance use and craving self-report assessments.
All study procedures (screening, consent and assessments) can be conducted virtually, by videoconference and online through the secure REDCap survey database. These procedures may also be conducted in-person at a CHA community mental health center, and/or at the Center for Mindfulness and Compassion (CMC, 350 Commerce Place, Malden, MA).
- Conditions
- PTSD, Substance Use Disorders
- Being tested
- PARTS-SUD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARTS-SUDBehavioural
The Program for Alleviating and Reducing Trauma, Stress and Substance Use (PARTS-SUD) is a 12-week, Internal Family Systems-based, group intervention with 6 individual clinical sessions on a biweekly basis.
| Study group | Role | What they receive |
|---|---|---|
| PARTS-SUD Arm | Experimental | The Program for Alleviating and Reducing Trauma, Stress and Substance Use (PARTS-SUD) is a 12-week, Internal Family Systems-based, group intervention with 6 individual clinical sessions on a biweekly basis. Receives: Behavioral: PARTS-SUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate
The primary aim of this study is to examine the feasibility of a live-online version of the PARTS program defined as 70% of participants completing at least 75% (9/12) of groups.
Measured: 12 weeks
Secondary outcomes (3)
Assessment completion
Feasibility as measured by greater than or equal to 70% of participants completing post study assessments
Measured: 12 weeks
Acceptability
Acceptability of the intervention as measured by a Theoretical Framework for Acceptability (TFA) overall acceptability item mean score > 3.5 out of 5.
Measured: 12 weeks
Engagement
Satisfaction questionnaire with at least a mean of 7.5 out of 10 on being willing to recommend the program to a friend.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Sep 2023
- Primary completion10 Jan 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Self Leadership
- Responsible party
- Principal investigator, Zev Schuman Olivier, Cambridge Health Alliance
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207409
- Sponsor's protocol ID
- CHA-IRB-23-24-237
- Acronym
- (PARTS-SUD)
- Status last verified
- Jan 2024
- First submitted
- 7 Sep 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for Alleviating and Reducing Trauma, Stress, and Substance Use (PARTS-SUD)
- ClinicalTrials.gov ID
- NCT06207409
- Acronym / sponsor ID
- (PARTS-SUD) / CHA-IRB-23-24-237
- Conditions
- PTSD, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- Foundation for Self Leadership
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-arm study will test the preliminary efficacy of a virtually delivered, live-online 12-week group model of Internal Family Systems (IFS) for individuals with posttraumatic stress disorder (PTSD) and substance use disorders (Program for Alleviating and Reducing Trauma, Stress, and Substance Use, PARTS-SUD).
Participants will be in a group for 12 weeks and will be asked to complete survey sessions at baseline and during week 4, 8 and 12.
Detailed description
The investigators have conducted a single arm study of a 16 week PARTS group-based program for PTSD symptoms, which demonstrated large effect reductions on PTSD symptoms, disturbances in self-organization (DSO), disassociation, emotion dysregulation, suicide risk, anxiety, depression, and increases in decentering and self-compassion. A randomized control trial (RCT) of PARTS groups vs. a control is currently underway and will complete by September 2023. This will be a single-arm feasibility and acceptability pilot study of PARTS for PTSD among patients with substance use disorders.
While 16 weeks is the typical length for PTSD intervention trials, the average treatment length for PTSD-SUD population studies is only 12 weeks given higher risk of attrition with longer treatments for substance use disorder (SUD). Clinically, the group is anticipated to have the most impact on symptoms between weeks and 12 based on the curriculum and practices during those sessions, so the investigators will pilot a 12 week group in this study. Similar to past PARTS studies, participants will also have every other week 50 minute individual counseling sessions. Since IFS and group psychotherapy are established modalities and the pilot trial for PARTS established its evidence as a program with a clinically meaningful effect, this feasibility and acceptability study will primarily focus on the engagement and acceptability of the intervention among patients with PTSD-SUD. Both group and individual sessions will be billed to insurance as per standard Cambridge Health Alliance (CHA) outpatient clinical protocols. To reduce burden from past studies, the investigators will not conduct Clinician-Administered PTSD Scale (CAPS-5) interviews, but solely use self-report measures (PTSD Checklist For DSM-5, PCL-5 and Computerized Adaptive Testing for PTSD, CAT-PTSD), which have a high level of correlation with CAPS-5.
The investigators aim to have 10-12 participants allocated to start the program aiming for 70% of completion of the study intervention (defined as 75% completion of sessions) and 70% completion of week 12 assessments with adequate intervention acceptability. After participants have completed all baseline screenings, assessments and the informed consent procedure, a study staff member will contact them to begin the virtual program delivered in real time over the secure, HIPAA compliant video conference (e.g. Google Meets, Zoom).
Surveys, Procedures and Duration The duration of the study period is 12 weeks (see Figure 1). Participants will complete screening surveys and a long survey battery at baseline; survey batteries (approximately 62 minutes) at study Week 4, 8 and 12; and weekly substance use and craving self-report assessments.
All study procedures (screening, consent and assessments) can be conducted virtually, by videoconference and online through the secure REDCap survey database. These procedures may also be conducted in-person at a CHA community mental health center, and/or at the Center for Mindfulness and Compassion (CMC, 350 Commerce Place, Malden, MA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PARTS-SUD Arm | Experimental | Behavioral: PARTS-SUDThe Program for Alleviating and Reducing Trauma, Stress and Substance Use (PARTS-SUD) is a 12-week, Internal Family Systems-based, group intervention with 6 individual clinical sessions on a biweekly basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to bill insurance for group psychotherapy and individual psychotherapy at CHA;
- Currently or willing to become a patient of CHA primary care or behavioral health care (as defined by an active CHA EPIC EHR record);
- Have a current diagnosis of PTSD OR a CAT-MH PTSD>58;
- Have a current diagnosis of a substance use disorder (SUD), positive Alcohol Use Disorders Identification Test AUDIT-C item about 5 or more drinks at once OR positive toxicology for or self-report of illicit drugs in the past year, or current treatment with medications for OUD, including buprenorphine, naltrexone or methadone.
- Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent;
Key exclusion criteria (17 listed)
- 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 four months from enrollment period;
- Expected incarceration in the next four months from enrollment period;
- Individuals who are pregnant with a due date within 16 weeks after study consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARTS-SUDThe Program for Alleviating and Reducing Trauma, Stress and Substance Use (PARTS-SUD) is a 12-week, Internal Family Systems-based, group intervention with 6 individual clinical sessions on a biweekly basis. | Behavioural | PARTS-SUD Arm |
Primary outcome
Completion Rate
Time frame: 12 weeks
The primary aim of this study is to examine the feasibility of a live-online version of the PARTS program defined as 70% of participants completing at least 75% (9/12) of groups.
3 secondary outcomes
Assessment completion
Time frame: 12 weeks
Acceptability
Time frame: 12 weeks
Engagement
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARTS-SUD in people with PTSD and Substance Use Disorders, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.