PTSD - Post Traumatic Stress DisorderNCT07397507
Mechanisms of Written Exposure Therapy in Residential SUD Treatment
A study testing Written Exposure Therapy and Neutral Writing in people with PTSD - Post Traumatic Stress Disorder and Substance Use Disorder (SUD), run by Mclean Hospital.
Trial summary
The goal of this clinical trial is to learn how Written Exposure Therapy (WET), a brief treatment for PTSD, works among individuals with substance use disorders (SUD) engaged in residential SUD treatment and how biology may influence treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Substance Use Disorder (SUD)
- What is being tested?
- Written Exposure Therapy and Neutral Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ability to understand and sign informed consent
- ability to write in English;
- age between 18-55 (average age of menopause in the US)
- [women only] naturally cycling (i.e., regular cycles, not on gonadal-related hormones)
- current diagnosis of a moderate or severe DSM-5 SUD
- current diagnosis of DSM-5 PTSD
- sufficient memory of the trauma to write about the event
- at least 5 business days left in their residential treatment episode (to allow for 5 treatment sessions).
Who cannot join
- presence of a psychiatric or medical condition that would interfere with participation (e.g., severe, uncontrolled psychosis)
- prescription of a PRN benzodiazepine
- current PTSD treatment
About this study
The goal of this clinical trial is to learn how Written Exposure Therapy (WET), a brief treatment for PTSD, works among individuals with substance use disorders (SUD) engaged in residential SUD treatment and how biology may influence treatment. The main questions it aims to answer are:
- Does WET improve PTSD and substance use outcomes among individuals with SUD+PTSD?
- Does WET improve physiological responses and craving to trauma cues?
- Do sex hormones influence changes physiological responses and craving during treatment among women?
Read more
Participants will:
- Complete WET or a neutral writing in addition to their residential SUD treatment
- Complete two laboratory sessions before and after treatment
- Complete follow-up surveys and interviews at 1- and 3-months post-treatment
- Being tested
- Written Exposure Therapy, Neutral Writing
- Keywords
- PTSD treatment, Written Exposure Therapy, Substance Use Disorder, treatment mechanisms, fear extinction
- Medical subject headings
- Combat Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
Written Exposure Therapy (WET) is a five-session manualized treatment for PTSD. At the first session, psychoeducation about common reactions to trauma and PTSD are presented followed by a 30-minute written exposure. Following the exposure, a 10-minute check-in is completed, and individuals are instructed not to avoid any thoughts/feelings/ images related to the trauma between sessions. All subsequent sessions follow this structure: check-in on avoidance and feedback on writing, written exposure, and brief check-in post-writing about the writing process.
Neutral WritingBehavioural
Participants will complete five writing prompts that are not intended to provoke emotional responses. Examples of these prompts include writing about the food they ate the day prior or what they did yesterday. Participants will be instructed to not discuss their thoughts and feelings regarding these topics. Neutral writing will provide control for time and clinician contact.
| Study group | Role | What they receive |
|---|---|---|
| WET | Experimental | This arm will receive Written Exposure Therapy in addition to residential SUD treatment. Receives: Behavioral: Written Exposure Therapy |
| Neutral Writing | Other | This arm will receive five sessions of neutral writing in addition to residential SUD treatment. Receives: Behavioral: Neutral Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Severity
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of symptoms of PTSD as defined by the DSM-5. Participants are instructed to keep in mind the identified worst event when responding to the items. Items are summed to create a total score which ranges from 0-80; a total score cut-off of 33 is recommended for identifying probable PTSD.
Measured: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge
Days of Substance Use
The Timeline Follow-Back (TLFB) method will be used to assess past 30-day substance use frequency and quantity. The TLFB will be administered by phone at 1-month and 3-month post-discharge. Days of use at Baseline will ask about the 30 days prior to entering treatment.
Measured: Baseline, 1- and 3-Month Post-Discharge
Heart Rate (HR)
Biopac MP150 for Windows will be used to collect electrocardiogram (ECG) data at a sampling rate of 1000 Hz. ECG is measured using three disposable Ag/AgCl electrodes and data are processed using MindWare software. HR will be derived by spectral analysis of 1-min epochs with a Hamming windowing function and log transformed. HR will be measured continuously during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). Average HR in beats per minute will be calculated during the trauma-cue (primary) and for each 30-minute writing session (secondary).
Measured: Baseline, Intervention Sessions, Immediately after intervention
Skin Conductance Response (SCR)
Biopac MP150 for Windows will be used to collect electrodermal activity (EDA) data at a sampling rate of 1000 Hz. EDA is measured using two finger electrodes and data are processed using MindWare software. EDA will be measured continuously during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). SCR will be calculated as the maximum SC amplitude during the trauma-cue adjusted for the average SC amplitude during the final 30-seconds of the rest phase (primary outcome). SCR during each WET session (secondary outcome) will be calculated as the maximum EDA amplitude during the written exposure, adjusted for baseline amplitude.
Measured: Baseline, Intervention Sessions, Immediately after intervention
High-Frequency Heart Rate Variability (HF-HRV)
Biopac MP150 for Windows will be used to collect electrocardiogram (ECG) data at a sampling rate of 1000 Hz. ECG is measured using three disposable Ag/AgCl electrodes and data are processed using MindWare software. HF-HRV will be derived by spectral analysis of 1-min epochs with a Hamming windowing function and log transformed. HF-HRV will be derived from ECG R-R intervals (inter-beat interval). Standard recommendations for the high frequency band settings (0.12- 0.40 Hz) will be used. HF-HRV will be measured during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). Average HF-HRV will be calculated during the trauma-cue (primary) and for each 30-minute writing session (secondary).
Measured: Baseline, Intervention Sessions, Immediately after intervention
Trauma-Reactive Craving
The Craving Scale is a 3-item validated measure of substance use craving. It uses a scale of 0-9 to assess: (1) the strength of craving in the past 24 hours, (2) the likelihood of use in an environment they have used in before, and (3) strength of cued craving. Craving will be assessed at all time points. Craving before and after the trauma-cue reactivity paradigm will be assessed and trauma-reactive craving will be the change in craving pre/post-trauma-cue (primary outcome). During the WET Intervention Sessions, substance use craving pre- and post- writing will be assessed and trauma-reactive craving will be calculated as post-writing craving adjusted for pre-writing craving (secondary outcome).
Measured: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups
Secondary outcomes (1)
Consequences of Substance Use
The Short Inventory of Problems - Revised (SIP-R) is a 17-item self-report of adverse consequences associated with drug or alcohol use in four domains: physical, social, intrapersonal, interpersonal, and impulse control. Items are rated on a scale of 0 (Never) to 3 (Daily or Almost Daily) representing the frequency of each consequence. A total score is calculated by summing all items, with higher scores reflecting greater consequences.
Measured: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robyn Ellis, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397507
- Sponsor's protocol ID
- 2025P003371
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Written Exposure Therapy in Residential SUD Treatment
- ClinicalTrials.gov ID
- NCT07397507
- Acronym / sponsor ID
- 2025P003371
- Keywords
- PTSD treatment, Written Exposure Therapy, Substance Use Disorder, treatment mechanisms, fear extinction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 9 Feb 2026 (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.
The goal of this clinical trial is to learn how Written Exposure Therapy (WET), a brief treatment for PTSD, works among individuals with substance use disorders (SUD) engaged in residential SUD treatment and how biology may influence treatment. The main questions it aims to answer are:
- Does WET improve PTSD and substance use outcomes among individuals with SUD+PTSD?
- Does WET improve physiological responses and craving to trauma cues?
- Do sex hormones influence changes physiological responses and craving during treatment among women?
Participants will:
- Complete WET or a neutral writing in addition to their residential SUD treatment
- Complete two laboratory sessions before and after treatment
- Complete follow-up surveys and interviews at 1- and 3-months post-treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WET | Experimental | Behavioral: Written Exposure TherapyThis arm will receive Written Exposure Therapy in addition to residential SUD treatment. |
| Neutral Writing | Other | Behavioral: Neutral WritingThis arm will receive five sessions of neutral writing in addition to residential SUD treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- ability to understand and sign informed consent
- ability to write in English;
- age between 18-55 (average age of menopause in the US)
- [women only] naturally cycling (i.e., regular cycles, not on gonadal-related hormones)
- current diagnosis of a moderate or severe DSM-5 SUD
Key exclusion criteria (3 listed)
- presence of a psychiatric or medical condition that would interfere with participation (e.g., severe, uncontrolled psychosis)
- prescription of a PRN benzodiazepine
- current PTSD treatment
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 |
|---|---|---|
| Written Exposure TherapyWritten Exposure Therapy (WET) is a five-session manualized treatment for PTSD. At the first session, psychoeducation about common reactions to trauma and PTSD are presented followed by a 30-minute written exposure. Following the exposure, a 10-minute check-in is completed, and individuals are instructed not to avoid any thoughts/feelings/ images related to the trauma between sessions. All subsequent sessions follow this structure: check-in on avoidance and feedback on writing, written exposure, and brief check-in post-writing about the writing process. | Behavioural | WET |
| Neutral WritingParticipants will complete five writing prompts that are not intended to provoke emotional responses. Examples of these prompts include writing about the food they ate the day prior or what they did yesterday. Participants will be instructed to not discuss their thoughts and feelings regarding these topics. Neutral writing will provide control for time and clinician contact. | Behavioural | Neutral Writing |
Primary outcome
PTSD Symptom Severity
Time frame: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of symptoms of PTSD as defined by the DSM-5. Participants are instructed to keep in mind the identified worst event when responding to the items. Items are summed to create a total score which ranges from 0-80; a total score cut-off of 33 is recommended for identifying probable PTSD.
Days of Substance Use
Time frame: Baseline, 1- and 3-Month Post-Discharge
The Timeline Follow-Back (TLFB) method will be used to assess past 30-day substance use frequency and quantity. The TLFB will be administered by phone at 1-month and 3-month post-discharge. Days of use at Baseline will ask about the 30 days prior to entering treatment.
Heart Rate (HR)
Time frame: Baseline, Intervention Sessions, Immediately after intervention
Biopac MP150 for Windows will be used to collect electrocardiogram (ECG) data at a sampling rate of 1000 Hz. ECG is measured using three disposable Ag/AgCl electrodes and data are processed using MindWare software. HR will be derived by spectral analysis of 1-min epochs with a Hamming windowing function and log transformed. HR will be measured continuously during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). Average HR in beats per minute will be calculated during the trauma-cue (primary) and for each 30-minute writing session (secondary).
Skin Conductance Response (SCR)
Time frame: Baseline, Intervention Sessions, Immediately after intervention
Biopac MP150 for Windows will be used to collect electrodermal activity (EDA) data at a sampling rate of 1000 Hz. EDA is measured using two finger electrodes and data are processed using MindWare software. EDA will be measured continuously during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). SCR will be calculated as the maximum SC amplitude during the trauma-cue adjusted for the average SC amplitude during the final 30-seconds of the rest phase (primary outcome). SCR during each WET session (secondary outcome) will be calculated as the maximum EDA amplitude during the written exposure, adjusted for baseline amplitude.
High-Frequency Heart Rate Variability (HF-HRV)
Time frame: Baseline, Intervention Sessions, Immediately after intervention
Biopac MP150 for Windows will be used to collect electrocardiogram (ECG) data at a sampling rate of 1000 Hz. ECG is measured using three disposable Ag/AgCl electrodes and data are processed using MindWare software. HF-HRV will be derived by spectral analysis of 1-min epochs with a Hamming windowing function and log transformed. HF-HRV will be derived from ECG R-R intervals (inter-beat interval). Standard recommendations for the high frequency band settings (0.12- 0.40 Hz) will be used. HF-HRV will be measured during the trauma-cue reactivity paradigm (primary outcome), and during WET treatment sessions (secondary outcome). Average HF-HRV will be calculated during the trauma-cue (primary) and for each 30-minute writing session (secondary).
Trauma-Reactive Craving
Time frame: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups
The Craving Scale is a 3-item validated measure of substance use craving. It uses a scale of 0-9 to assess: (1) the strength of craving in the past 24 hours, (2) the likelihood of use in an environment they have used in before, and (3) strength of cued craving. Craving will be assessed at all time points. Craving before and after the trauma-cue reactivity paradigm will be assessed and trauma-reactive craving will be the change in craving pre/post-trauma-cue (primary outcome). During the WET Intervention Sessions, substance use craving pre- and post- writing will be assessed and trauma-reactive craving will be calculated as post-writing craving adjusted for pre-writing craving (secondary outcome).
1 secondary outcome
Consequences of Substance Use
Time frame: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy and Neutral Writing in people with PTSD - Post Traumatic Stress Disorder and Substance Use Disorder (SUD), run by Mclean Hospital.
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 3 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
PTSD Symptom Severity (time frame: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge). The study lists 6 primary outcomes in all. 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 9 Feb 2026.