Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05268367 |
| Other study ID # |
69410 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 31, 2022 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
June 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
Mental contamination-an internal experience of dirtiness evoked in the absence of physical
contact with an external source-has been linked to the development and maintenance of
posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et
al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated
with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD
symptom clusters (particularly those of intrusive re-experiencing, negative cognitions/mood,
and arousal/reactivity; Brake et al., 2019; Fergus & Bardeen, 2016). Additionally,
trauma-related mental contamination has been linked to a number of negative posttraumatic
emotions such as shame, guilt, disgust, and anger (Fairbrother & Rachman, 2004; Radomsky &
Elliott, 2009). Despite clear and consistent links between mental contamination and
problematic posttraumatic outcomes following sexual trauma, there is a dearth of research
investigating how existing or promising new interventions for PTSD impact mental
contamination.
Written Exposure Therapy (WET) is a five-session treatment for PTSD that was designed to be
both brief and easy to administer (Sloan et al., 2012). According to Sloan and colleagues'
(2012) protocol, sessions broadly involve 30-minute exposures in which the patient writes
about the events of their trauma in detail, followed by 10 minutes of discussing the exposure
with the therapist. This treatment protocol has minimal therapist involvement, no homework
assignments, and shorter treatment sessions. Research shows that WET is efficacious among
different samples (e.g., survivors of motor vehicle accidents and combat veterans), has low
dropout rates, treatment satisfaction is high, and the gains seen by participants after
completion are maintained at follow-up (Sloan et al., 2012, 2013, 2018; Thompson-Hollands et
al., 2018, 2019). Given these factors, WET has the potential to be a useful intervention in
reducing symptoms of PTSD among a sample of survivors of sexual trauma. Given its relevance
to this trauma population, a test of this intervention for its impact on reducing
trauma-related mental contamination is also needed.
The current study will use Single Case Experimental Design to isolate and evaluate the
effects of WET in reducing both PTSD symptoms and trauma-related mental contamination among
individuals with PTSD resulting from sexual trauma.
Aims: Explore whether participants demonstrate reductions in mental contamination and PTSD
symptoms in response to 5 sessions of WET. Visual inspection analysis and statistical methods
will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms
and mental contamination.
Description:
Individuals interested in participating in this study will complete a phone screening to
determine if they are likely to be eligible and can be scheduled for an in-person diagnostic
intake to take place at the Stress Trauma and Recovery Research Collaborative (STARRC) within
the UK Clinic for Emotional Health or via HIPAA compliant Zoom. All participants will be
provided with details regarding the phone screen questions and will be required to provide
verbal consent over the phone before proceeding with the phone screen.
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 and informed consent will
be obtained in compliance with the University of Kentucky's Institutional Review Board (UK
IRB) for these questionnaires. 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, or remotely, through REDCap in which they will be
asked to provide a digital signature. If consent is provided, they will be given the option
to be emailed a copy. They may also request a signed paper copy of the consent for their
records or if they have additional questions in the future. 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 or online 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.
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. We do not have reason to expect that participants are
likely to have impaired consent capacity in this study. However, in a previous study our lab
conducted where we did have this expectation we included a consent capacity evaluation
document and found that we liked using it as an extra check that participants were aware of
the study details and what they were agreeing to, and could state back to us in their own
words what they could do if they became uncomfortable or decided they wished to take a break,
skip sections, or discontinue the study. It is now our lab's standard operating procedure to
include this measure in all in-person studies.
Upon referral to the study, participants will complete a brief telephone screening. The
screen will predominantly be conducted by trained undergraduate/post-baccalaureate
research/clinic assistants, however the PI, Co-Is, or a supervised graduate
students/post-doctoral scholars may also conduct the phone screens. Screening forms for
individuals who are deemed ineligible for the study will be retained for study records and
research purposes. Likely eligible participants, determined by the phone screen, will be
asked to complete a battery of self-report questionnaires, which will assess symptoms of
anxiety/depression, shame, level of functioning (e.g., quality of life), and measures of PTSD
and mental contamination (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). Resources to manage symptom difficulty will also be provided.
Participants will also be invited to attend the intake in-person in the PI's research lab at
the Clinic for Emotional Health or via HIPAA-compliant video conferencing service (i.e., Zoom
via the UK HealthCare portal). 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. This assessment visit will be video and/or
audio-recorded. Recording via audio and/or video will be required for participation. Those
who are deemed ineligible after this assessment will be withdrawn and given referrals and/or
other resources as needed.
Eligible participants will then be randomized to either a three- or five-week baseline where
they will complete weekly measures of PTSD symptoms, mental contamination, shame, and
symptoms of anxiety/depression. This battery will be repeated each week during therapy
sessions, along with additional post-session ratings about treatment credibility and
therapeutic alliance. Participants will then be scheduled for their first study session
either in-person or via HIPAA compliant Zoom, in which they will begin their first of five
WET sessions. 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 after their last treatment session. For four weeks after treatment completion,
participants will complete the same battery of questionnaires they have completed weekly
throughout the course of the baseline and treatment phases. Participants will be compensated
up to $20 for each of the follow-up questionnaire batteries (4 assessments at $5 each). A
check with their earnings will be mailed to their reported address or given in-person after
completion of the last set of weekly questionnaires (up to $20).
All therapy sessions will last for approximately 40-60 minutes in duration. It is important
to note that the therapeutic strategies involved in WET are all common, evidence-based
cognitive-behavioral strategies. The treatment involves written exposures as instructed by an
established manual (Written Exposure Therapy for PTSD) and brief discussion of the exposure
with the therapist. Treatment sessions will be audio- and/or video-recorded; 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 or HIPAA
compliant Zoom to complete the survey batteries during their own time. Finally, although we
anticipate that most patients will prefer to complete these measures electronically, we can
provide paper and pencil versions of the questionnaires if requested.
Data collection will be accomplished via phone screening questions, diagnostic interview, and
self-report questionnaires. Through these measures we will collect data regarding
participants' experiences with psychological symptoms, life functioning, and treatment
satisfaction. The measures will be administered according to the following schedule:
Baseline, Intake, and Follow-up Treatment Assessments: Demographics (Intake and First
Baseline Assessment), DIAMOND self-report screener (First Baseline Assessment), DIAMOND
interview (Intake), Fairbrother and Rachman Mental Contamination Interview Items (Intake),
Treatment Services Tracking Form (Intake), CSSRS/SAFE-T (Intake), Q-LES-Q (Intake and
Follow-up), PCL-5 - Weekly, PEMC - Weekly, TRSI-SF - Weekly, ODSIS - Weekly, OASIS - Weekly
Pre-Session (Weekly): PCL-5 - Weekly, PEMC - Weekly, TRSI-SF - Weekly, ODSIS - Weekly, OASIS
- Weekly, CSSRS - Weekly, Treatment Services Tracking Form - Weekly
Post-Session (Weekly): HAQ - Patient and Therapist - Weekly, CEQ (post-1st treatment session
only), Patient Satisfaction Form (final treatment session only)
We 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).
