An interventional study of Written Exposure Therapy and Neutral Writing in PTSD - Post Traumatic Stress Disorder and Substance Use Disorder (SUD), sponsored by Mclean Hospital. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Mclean Hospital · Not applicable, Interventional, and Treatment
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:
Participants will:
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 108 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Mclean Hospital is the lead sponsor of 185 studies on the registry; 32 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive Written Exposure Therapy in addition to residential SUD treatment.
Behavioral: Written Exposure Therapy
This arm will receive five sessions of neutral writing in addition to residential SUD treatment.
Behavioral: Neutral Writing
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.
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Intervention Sessions, Immediately after intervention, 1- and 3-Month Post-Discharge Follow-ups
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.
Time frame: Baseline, Immediately after intervention, 1- and 3-Month Post-Discharge
No study locations are listed for this record.
Start is estimated for Jun 2026; primary completion for Dec 2029, 42 months later.
Of 73 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 42 months is above that.
Counting every sponsor, half of 79 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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