Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05817344 |
| Other study ID # |
81761 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 9, 2024 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
University of Kentucky |
| Contact |
Jesse McCann, MS |
| Phone |
(859) 562-1571 |
| Email |
jmccann[@]uky.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Posttraumatic stress disorder (PTSD) is associated with increased rates of prescription
opioid misuse, high-risk opioid use, illicit use of substances, and overdose (Meshberg-Cohen
et al., 2021) Some research has demonstrated that among individuals with opioid use disorder
(OUD), 92% report exposure to a traumatic event (Mills et al., 2005). Approximately 41% of
those with OUD have a lifetime history of PTSD and 33.2% of individuals with OUD meet current
diagnostic criteria for PTSD, indicating very high rates of PTSD among people with
co-occurring OUD (Mills et al., 2006, 2007). PTSD also prospectively increases risk for OUD
after exposure to opioids (Hassan et al., 2017).
Medications for opioid use disorder (MOUD) are evidence-based pharmacological interventions
for OUD (methadone, buprenorphine, naltrexone) to manage pain and withdrawal (Leshner &
Mancher, 2019). Though effective, dropout from MOUD programs is high (Mokri et al., 2016;
O'Connor et al., 2020). It is also common in substance use disorder (SUD) treatment settings
not to treat PTSD (Norman & Hien, 2020), though concurrent PTSD and MOUD treatment is
associated with higher continuation in MOUD programs compared to no PTSD treatment
(Meshberg-Cohen et al., 2019; Schacht et al., 2017). Despite this, there is little data
regarding efficacy or effectiveness of specific trauma-focused PTSD treatments among patients
in MOUD programs.
Combined with effective cognitive-behavioral techniques for substance use disorder (SUD),
evaluation of brief, trauma-focused interventions for PTSD has substantial potential to
improve care for individuals with PTSD receiving MOUD. The present study will begin to
address this need by evaluating the feasibility, acceptability, and initial efficacy of
Written Exposure Therapy (WET) for PTSD integrated with harm reduction skills for managing
SUD symptoms among a sample of patients receiving MOUD [Written Exposure Therapy-Integrated
(WET-I)]. WET is a five-session treatment for PTSD requiring limited therapist training and
minimal patient burden (Sloan & Marx, 2019). WET has shown comparable outcomes to
gold-standard interventions for PTSD, with improved retention rates (Sloan et al., 2018). WET
has marked potential within this population, especially given that many clinicians in SUD
programs do not have specialized training in PTSD treatments (Killeen et al., 2015).
Using a multiple baseline single case experimental design (SCED), 6 participants with current
PTSD and current or past OUD will be recruited from MOUD treatment programs to engage in 5
weekly sessions of WET-I. Participants will complete an intake assessment to establish PTSD
and OUD diagnoses and will be randomized to a 3- or 5-week baseline assessment period. Weekly
assessments of symptoms (i.e., PTSD, anxiety, depression), substance craving and use, quality
of life, and compliance with MOUD treatment will be completed during the baseline, treatment,
and one-month follow-up phase. During the treatment phase, participants will also complete
weekly measures of therapeutic alliance and will provide feedback on treatment credibility
and treatment satisfaction.
Aim 1: To examine feasibility and acceptability of WET-I among participants in MOUD treatment
with co-occurring PTSD/OUD. Feasibility of WET-I will be demonstrated via treatment retention
and completion. Acceptability of engaging in WET-I in tandem with MOUD treatment will be
demonstrated via high patient credibility ratings of WET-I and high treatment satisfaction
ratings.
Aim 2: To determine if WET-I can significantly reduce symptoms of PTSD, anxiety, and
depression in participants with comorbid PTSD and OUD and to monitor changes in drug use
behaviors and craving over the treatment period. Participants will report reliable clinical
improvement in symptoms (PTSD, anxiety, depression) and quality of life during the treatment
phase and post-assessment without corresponding increases in substance use behavior or
craving, and these improvements will be maintained at follow-up.
Description:
Individuals interested in participating in this study will complete a phone screening or
online screening based on individual preference to determine if they are likely to be
eligible and can be scheduled for a telehealth or in-person diagnostic intake to take place
at the Stress Trauma and Recovery Research Collaborative (STARRC) within the UK Clinic for
Emotional Health. All participants will be provided with details regarding the screening
questions and will be required to provide verbal consent over the phone or review a cover
letter consent form (similar to the phone screening) online before proceeding with the
screening. Once scheduled for an intake, participants will be sent a link to complete the
intake questionnaires online prior to the start of the intake appointment. A cover letter
consent form is attached for these questionnaires, as they will be administered before the
in-person intake session. During the intake session, the participant will first be given a
written and verbal description of the study and informed consent. The consent form will be
presented to the participant on a tablet through REDCap, or via HIPAA-Compliant Zoom if
telehealth, in which they will be asked to provide a digital signature. If consent is
provided, they will be provided a copy. The PI or designated staff will discuss the informed
consent form with the participant volunteer. The consent process will take place in a quiet
and private room in our office or via HIPAA-Compliant Zoom. Participants may take as much
time as needed to make a decision about their trial participation and may take the document
home if desired. The person obtaining consent will thoroughly explain each element of the
document and outline the risks and benefits, alternative treatment(s), and requirements of
the study. Participants will be informed that they can withdraw from the research at any
time.
Procedures and consent forms will comply with the requirements of the UK-IRB and ORI's Best
Practices for Remote Informed Consent. The experimenter will then complete a consent
post-test with participants. If a participant screens out of the study due to a consent
capacity issue, any data from that participant that may have been previously collected during
the phone screening and/or online surveys will not be used for research purposes and will be
destroyed. Participants will also agree to the study's intoxication policy before signing the
consent form. Participant privacy will be maintained and questions regarding participation
will be answered. No coercion or undue influence will be used in the consent process. No
research-related procedures will be performed prior to obtaining informed consent. All
signatures and dates will be obtained. A copy of the signed consent will be given to the
participant. Signed electronic consents will be maintained and stored through REDCap and will
be separated from participant data.
After completing and signing the consent form at the intake appointment, eligible
participants will be required to sign a release of information from the research team
granting the research team permission to contact their methadone or buprenorphine program to
coordinate care for the participant. Any additional release of information required from
individual methadone or buprenorphine treatment facilities will be obtained for each
participant as needed.
Initial Screening
Upon referral to the study, participants will complete a brief phone or internet screening
based on participant preference to determine eligibility for an intake appointment. Screening
forms for individuals who are deemed ineligible for the study for reasons other than consent
capacity issues will be retained for study records and future research purposes that may be
developed in the lab or by lab collaborators for which data may be useful.
First Baseline and Intake
Likely eligible participants, determined by the initial screen, will be asked to complete a
battery of self-report questionnaires, which will assess for presence of DSM-5 psychological
disorders, symptoms of anxiety/depression, level of functioning (e.g., quality of life),
measures of PTSD, substance use, and substance craving (also to be completed online via
REDCap). This survey platform is designed specifically for collection of research data, and
therefore meets the privacy standards imposed on health care records by the Health Insurance
Portability and Accountability Act (HIPAA). Referral information for resources to manage
symptom difficulty will also be provided in the cover letter for these questionnaires. Likely
eligible participants will be invited to attend the intake in-person or via telehealth in the
PI's research lab at the Clinic for Emotional Health. A study assessor (i.e., doctoral
students in clinical psychology/post-doctoral scholar/PI/Co-Is) will review study procedures
with potential participants and ask them to provide their informed consent. After informed
consent is provided, an interview-based diagnostic assessment will be administered in order
to confirm clinical inclusion/exclusion criteria and urine and breathalyzer substance use
screenings will be completed (for in-person participants only). This assessment visit will be
video and/or audio-recorded. Recording via audio and/or video will be required for
participation. Those who do not meet criteria for PTSD and/or other eligibility criteria will
be told at the end of the assessment that they will not be able to continue in the study and
will be provided referrals in-person or over email or postal mail for other treatment options
depending on participant preference. Participants who do not endorse required eligibility
criteria or who do endorse ineligibility criteria during the intake will not be permitted to
continue in the study.
Baseline Period
Eligible participants will then be randomized to either a three- or five-week baseline where
they will complete weekly measures of PTSD symptoms, symptoms of anxiety/depression, quality
of life, substance use, and substance craving, and questions to determine whether they are in
compliance with requirements of their MOUD program.
Treatment Period
The same questionnaire battery and substance use screenings will be repeated each week during
therapy sessions, along with additional post-session ratings about treatment credibility and
therapeutic alliance as well as interviews of substance use and urine and breathalyzer
substance use screenings (for in-person participants). Urine and breathalyzer tests are
standard operating procedure for studies assessing substance use behaviors in addition to
self-reports of substance use.
Offering biological data to support participant self-reports is consistent with common
research practices and will bolster scientific rigor of data reported in published
manuscripts. If participants are completing treatment remotely, they will not complete
substance use urine/breathalyzer screenings, but will still complete interviews of substance
use via HIPAA-Compliant Zoom. Participants will then begin their first of five WET-I
sessions. In WET, patients are provided with psychoeducation about trauma and PTSD in their
first session and given explicit instruction on writing about the details of their most
distressing trauma throughout treatment for 30 minutes each session followed by 10 minutes of
structured discussion regarding the writing process. At the end of this discussion,
therapists will introduce harm reduction strategies that will include 20 minutes of
discussion in which therapists and participants will work together to establish and track the
participant's goals for maintaining recovery over the next 5 weeks, discuss how engagement in
WET-I can impact or cause barriers to these goals as well as ways in which the therapist can
assist them in reducing barriers and achieving their goals, and discuss skills for safe
substance use as needed (e.g., minimizing mixing substances, testing substances for fentanyl,
using substances with people equipped to administer naloxone). The first session will be
approximately 80 minutes while the remaining four will be approximately 60 minutes in length.
Following completion of the treatment, participants will be asked to provide satisfaction
ratings and written qualitative feedback on their experience with the treatment they received
at the end of their last treatment session.
In order to bolster participation in weekly assessments, participants will be compensated up
to $50 for each of the weekly baseline questionnaire batteries/drug screenings. If all
assessments are not completed, they will receive funds for the amount of baseline assessments
that they did complete. Participants will also receive up to an additional $50 for completion
of each of the weekly questionnaire batteries during the treatment portion of the study.
Participants will complete the same questionnaire/screening battery for three additional
weeks following their post-treatment assessment one week after ending treatment.
It is important to note that the therapeutic strategies involved in WET-I are all common,
evidence-based cognitive-behavioral strategies that have been shown to be safe among
substance using populations. The treatment involves written exposures as instructed by an
established manual (Written Exposure Therapy for PTSD) and brief processing of the exposure
with the therapist. Treatment sessions will be audio- and/or video-recordedÍž this will allow
study staff to rate sessions for fidelity to the protocol and will be used for clinical
supervision. Recording via audio and/or video will be required for participation.
All self-report questionnaires will be completed online via REDCap. Questionnaires will be
completed on-site using a study iPad or participants will be sent a link via email to
complete the survey batteries during their own time. Finally, although investigators
anticipate that most patients will prefer to complete these measures electronically,
investigators can provide paper and pencil versions of the questionnaires if requested.
Data collection will be accomplished via screening questions, diagnostic interview, and
self-report questionnaires attached below.
Through these measures investigators will collect data regarding participants' experiences
with psychological symptoms, life functioning, and treatment satisfaction. Participants
completing the study via telehealth will be sent REDCap links that to access the secure
questionnaires that are specific to them.
The measures will be administered according to the following schedule:
Baseline, Intake, and Follow-Up Assessments:
Participants completing the intake session remotely or in-person will complete all of the
same measures/assessments, with the exception of urine and breathalyzer screenings, which
will only be completed by in-person participants.
Demographics - Intake and First Baseline Assessment, DIAMOND self-report screener - First
Baseline Assessment, DIAMOND interview - Intake, Treatment Services Tracking Form - Intake,
Last Follow-up Assessment, CSSRS/SAFE-T - Intake, AUDIT - First Baseline Assessment, DUDIT -
First Baseline Assessment, Q-LES-Q - Weekly, TLFB - Weekly, Substance Craving - Weekly, PCL-5
- Weekly, ODSIS - Weekly, OASIS - Weekly, MOUD Compliance - Weekly, Urine and Breathalyzer
Screenings - Weekly for in-person clients only
Pre-Session and Post-Treatment Assessment (Weekly):
Q-LES-Q - Weekly, PCL-5 - Weekly, TLFB - Weekly, Substance Craving - Weekly, ODSIS - Weekly,
OASIS - Weekly, MOUD Compliance - Weekly, Treatment Services Tracking Form - First Therapy
Session, Last Therapy Session, Urine and Breathalyzer Screenings - Weekly for in-person
clients only, AUDIT - Post-Treatment Assessment, DUDIT - Post-Treatment Assessment
Post-Session (Weekly):
HAQ - Patient and Therapist - Weekly, CEQ (post-1st treatment session only), Patient
Satisfaction Form (final treatment session only)
Investigators plan to utilize a randomized multiple baseline design across participants
(Barlow et al., 2009; Kazdin, 2011). This is a form of single-case experimental design that
provides a time and cost-effective method of evaluating initial efficacy or effectiveness of
an intervention while controlling for the passage of time and repeated assessment in small
numbers of patients. Patients will be randomized to either a 3- or 5-week baseline assessment
phase where weekly self-report measures will be completed prior to initiating the treatment
phase of the study. Randomizing to varying baseline periods enables assessments of whether
symptoms change (only or more rapidly) when the intervention is applied (i.e., each
participant acts as their own control). This design allows for causal inferences and controls
for many threats to internal validity. Consistent with established guidelines, quantitative
data analysis will primarily be conducted via visual inspection of graphed data within- and
between-subjects to evaluate the magnitude and rate of change across the baseline and
treatment phases (Barlow et al., 2009; Kazdin, 2011). This will be supplemented by examining
within-person mean difference effect sizes for each outcome using a d-statistic developed for
single case designs and calculating the percentage of patients who evidence reliable change
on symptom measures (Jacobson & Truax, 1991; Shadish et al., 2014).
