Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04585685 |
| Other study ID # |
59226 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2020 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
October 2023 |
| Source |
University of Kentucky |
| Contact |
Christal L Badour, PhD |
| Phone |
859-323-3817 |
| Email |
Christal.badour[@]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 reexperiencing, 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.
Cognitive Processing Therapy (CPT) is an efficacious and effective 12-session manualized
cognitive-behavioral intervention for PTSD that is considered a gold-standard
empirically-supported treatment for PTSD that is recommended by the American Psychological
Association (APA, 2017). In addition to PTSD symptom improvement, CPT has also demonstrated
benefit for improving feelings of shame and guilt, which are often seen among individuals
with trauma-related mental contamination (Nishith et al., 2005; Resick et al., 2002, 2008).
Cognitive reappraisal, a primary technique employed in CPT, involves challenging one's view
of an emotionally-eliciting situation to alter its emotional impact (Gross & John, 2003).
However, some investigators have suggested that cognitive reappraisal may be less effective
in targeting moral emotions such as shame, guilt, and self-disgust that are based on an
individual's standards and virtues (Finlay, 2015). Self-compassion (SC; i.e., self-directed
care and kindness; forgiveness; and feelings of common humanity; Neff, 2003) has been
proposed as an alternative method for addressing trauma-related shame and preliminary
evidence suggests a 6-session self-compassion intervention may have benefit for reducing both
PTSD symptoms and trauma-related shame (Au et al., 2017). Given the centrality of shame,
guilt, and self-disgust to the experience of mental contamination, and the fact that mental
contamination often arises in response to experiences involving moral violation or betrayal
(Millar et al., 2016; Rachman, 2010), a SC intervention for PTSD may also offer promise as a
standalone or adjunctive intervention for reducing trauma-related mental contamination. A
test of these interventions for their impact on reducing trauma-related mental contamination
is needed.
The current study will use Single Case Experimental Design to isolate and evaluate the
effects of CPT and SC in reducing both PTSD symptoms and trauma-related mental contamination
among individuals with PTSD resulting from sexual trauma.
Aims: 1) explore whether participants demonstrate reductions in mental contamination and PTSD
symptoms in response to 12-sessions of CPT or 6-sessions of a SC intervention; 2) evaluate
whether presentation of either treatment first yields differences in symptom reduction for
PTSD and/or mental contamination symptoms; 3) evaluate whether the addition of the
alternative module will enhance reductions in PTSD symptoms and mental contamination; 4)
evaluate if such reductions are maintained during follow-up.
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:
In this multiple baseline single case experimental design with phase shift, up to 100
participants will be screened to identify 12 eligible individuals to participate in all study
procedures. After the baseline assessment, participants will be randomized (1:1 ratio) to
either a two or four-week baseline phase (assessment-only). Participants will then be
randomized (1:1 ratio) to either a 12-session CPT intervention or a 6-session self-compassion
intervention. All participants will complete one orientation session at the beginning of the
first treatment phase. Following a second three-week baseline phase, all participants will
then shift into the alternate intervention. Participants will be invited to complete a
post-treatment and one-month follow-up assessment. In total, participants who take part in
this research study will be in this research study for up to 34 weeks and will attend up to
20 in-person study visits.
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 (i.e., the PI's research lab space located on Waller
Avenue in an office park rented by the University of Kentucky) or via HIPAA compliant Zoom.
All participants will be provided with details regarding the phone screen questions and will
be required to provide implied consent over the phone before proceeding with the phone
screen.
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. They may request a paper copy if preferred. If consent is provided, they
will be given the option to be emailed 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 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 follow-up
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 Institutional Review Board and Office of Research Integrity'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.
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.
Any study personnel member who obtains informed consent from a patient will not serve as that
participant's assigned therapist.
Upon referral to the study via the recruitment methods described above, 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 to be ineligible for the study will be
shredded. Likely eligible participants, determined by the phone screen, will 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). As
described above (see "Informed Consent" section), 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 or
audio-recorded provided participants give their consent for this.
Next, participants will be asked to complete a battery of self-report questionnaires, which
will assess symptoms of anxiety/depression, level of functioning (e.g., quality of life),
experiential avoidance, self-compassion, and perceptions of how their history of sexual
trauma have impacted their life. Those who are deemed ineligible after this assessment will
be withdrawn.
Eligible participants will then be randomized to either a two- or four-week baseline where
they will complete weekly measures of PTSD symptoms mental contamination, trauma-related
shame and guilt, 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 randomly assigned to one of
two treatment orders (CPT, SC or SC, CPT) and will be scheduled for their next study session
either in-person or via HIPAA compliant Zoom. All participants will first be scheduled for a
therapy orientation session prior to beginning either CPT or SC. The therapy orientation
session will be used to develop rapport between the therapist and participant, and will
involve an interview to assess for details of the index traumatic event and experiences of
trauma-related mental contamination. Following completion of each treatment (12 or 6
sessions), participants will be asked to provide satisfaction ratings and written qualitative
feedback on their experience with the treatment they received. Participants will then enter a
second three-week return to assessment period where they will continue to complete
questionnaires weekly before beginning the second treatment module. Participants will also
complete a post-treatment questionnaire packet and continue to track their symptoms weekly
for three weeks following the conclusion of treatment via self-report.
All therapy sessions will last for approximately 60-90 minutes in duration. It is important
to note that the therapeutic strategies involved in both treatments are all common,
evidence-based cognitive-behavioral- or mindfulness-based strategies. The treatments involve
reading from an established manual (Cognitive Processing Therapy for PTSD or Compassion-Based
Therapy for Trauma-Related Shame and Posttraumatic Stress) and completing homework
assignments outside of the treatment session. These treatment sessions will be audio- or
video-recorded provided participants give their consent for this; this will allow study staff
to rate sessions for fidelity to the protocol and will be used for clinical supervision.
All self-report questionnaires will 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). 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 we anticipate that most patients will prefer to complete these
measure 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 attached below. 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:
Intake and Final Treatment Sessions:
Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric
Disorders (DIAMOND) interview (Only at Intake) Columbia-Suicide Severity Rating Scale (CSSRS)
with SAFE-T Risk Assessment Demographics (Only at Intake) PTSD Checklist for DSM-5 (PCL-5) -
Weekly Posttraumatic Experience of Mental Contamination (PEMC) - Weekly Trauma-Related
Symptom Inventory (TRSI) - Weekly Trauma-Related Guilt Inventory (TRGI) - Weekly Overall
Depression Severity and Impairment Scale (ODSIS) - Weekly Overall Anxiety Severity and
Impairment Scale (OASIS) - Weekly Centrality of Events Scale (CES) Self-Compassion Scale
(SCS) Obsessive Compulsive Inventory-Revised (OCI-R) Brief Experiential Avoidance
Questionnaire (BEAQ) Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
(Q-LES-Q) Patient Satisfaction Form (final treatment sessions only)
Treatment Orientation Session:
Treatment Services Tracking Form (Intake only) Trauma Interview
Pre-Session (Weekly):
PCL-5 - Weekly PEMC - Weekly TRSI - Weekly TRGI - Weekly CSSRS - Weekly (in-person sessions
only) Treatment Services Tracking Form - Weekly (in-person sessions only)
Post-Session (Weekly):
ODSIS - Weekly OASIS - Weekly Helping Alliance Questionnaire-II (HAQ-II) - Patient and
Therapist CEQ (post-1st treatment sessions only)
The goal of Aim 1 is to collect descriptive information regarding prevalence of trauma
history and PTSD, perceptions of connections between trauma history and substance use, and
interest in trauma-informed treatment. This information will be utilized to a) support the
feasibility of a future grant application and b) identify potential patients for the
treatment portion of the study.
Though the primary focus of Aim 2 is to collect data regarding feasibility, acceptability,
and patient feedback regarding areas of modification to inform a future grant proposal, we
plan to utilize a randomized, nonconcurrent 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 2- (n=3) or 4-week (n =3)
baseline assessment phase where weekly self-report measures will be completed prior to
initiating each treatment. 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). Participants will also be randomly assigned to the
order that they receive the treatment, with a 3-week return to baseline between treatments to
allow us to examine how symptoms change within each intervention period. 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).
