Mechanisms of Written Exposure Therapy in Residential SUD Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMclean Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Written Exposure Therapy
BehavioralWritten 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 Writing
BehavioralParticipants 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: WETExperimental treatment 1 intervention
Group B: Neutral WritingOther 1 intervention
Trial outcomes
Primary outcomes
1
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-Discharge2
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-Discharge3
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 intervention4
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 interventionSecondary 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.
Time frame
Baseline, Immediately after intervention, 1- and 3-Month Post-DischargeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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