Monitoring-only Control Clinical Trial
Official title:
Fading Safety Behaviors in an Internet-Based Secondary Prevention for Posttraumatic Stress Disorder
Research on decreasing safety behaviors in therapy has been restricted to treatments for
other anxiety disorders and has not included PTSD. In order to address this gap and to
develop a widely accessible, cost-effective prevention, an internet-based, three-arm
randomized secondary PTSD prevention trial is proposed. Self-help psychoeducation on common
reactions to trauma and eliminating safety behaviors will be employed for participants who
have recently experienced a traumatic event. Participants will be randomized to receive (a)
psychoeducation on trauma symptoms only, (b) combined psychoeducation on trauma symptoms and
eliminating safety behaviors, or (c) monitoring only control. All participants will monitor
safety behaviors and trauma symptoms weekly for eight weeks. Psychoeducation materials will
be handouts and videos administered online via REDCap.
It is hypothesized that participants in both psychoeducation conditions will have a lower
incidence of PTSD, threat appraisal, and safety behaviors than participants in the
monitoring-only control. It is also hypothesized that participants who receive combined
psychoeducation on trauma symptoms and fading safety behaviors will have a lower incidence of
PTSD, threat appraisal, and safety behaviors at Weeks 4 and 8 than will participants who
receive psychoeducation on trauma symptoms only or participants in the monitoring-only
control. It is further hypothesized that the effects of combined psychoeducation on
preventing PTSD and threat appraisal will be mediated by decreased use of safety behaviors.
Finally, it is hypothesized that combined psychoeducation on trauma symptoms and fading
safety behaviors will be more effective in preventing PTSD for participants with higher
levels of safety behaviors or threat appraisal at baseline. If effective, this secondary
prevention program could be distributed widely to people who have recently experienced a
trauma to prevent their development of PTSD.
Baseline Assessment Participants will first access the study online through web links posted
to widely accessible websites such as Facebook, Reddit, and Craigslist, and through The
University of Texas at Austin PSY 301 SONA pool. Participants will also be recruited through
Amazon Mechanical Turk. Participants will provide informed consent and will complete
eligibility criteria, which will take approximately 5 minutes. Participants who meet
eligibility criteria will immediately complete a baseline assessment, which will take
approximately 25 minutes, including a basic demographics questionnaire and a thorough
assessment of psychopathology symptoms and safety behaviors.
Randomization Immediately after baseline assessment, each participant will be automatically
randomized into one of three study conditions. Randomization will be stratified based on
number and severity of safety behaviors used and level of Acute Stress Disorder symptoms
reported at baseline. Once randomized, participants in the two psychoeducation conditions
will immediately receive psychoeducation materials, and all participants will receive
rationale for their study condition, as specified below. All three conditions will complete
the same schedule of assessments.
Conditions
Condition 1: Psychoeducation on trauma symptoms (PSYED-T) In Condition 1, participants will
receive view a psychoeducation handout and video on trauma symptoms. Participants in this
condition will also receive a rationale stating that learning about the nature of trauma
reactions as well as monitoring trauma reactions and safety behaviors are important for
preventing development of PTSD.
Condition 2: Combined psychoeducation on trauma symptoms and fading safety behaviors
(PSYED-T+SB) Participants in Condition 2 will receive view a psychoeducation handout and
video on trauma symptoms and on safety behaviors and how to fade them. Participants in this
condition will also receive a rationale stating that learning about the nature of trauma
reactions, learning to eliminate safety behaviors, and monitoring trauma reactions and safety
behaviors are important in the prevention of PTSD.
Because it is expected that the psychoeducational information provided in PSYED-T+SB
condition to be beneficial to participants, all participants will receive this information
upon completion of the study.
Condition 3: Monitoring-only control Condition 3 will be a monitoring-only control and thus
will receive no psychoeducation handouts or videos. Participants in this condition will
receive a rationale that monitoring trauma reactions and safety behaviors is important in the
prevention of PTSD development.
Psychoeducation At baseline, participants will receive a web link to the psychoeducation
materials via email. Participants will then be instructed to carefully read the handout and
watch the video and encouraged to revisit the materials throughout the course of the study.
Immediately following baseline exposure to psychoeducation materials, all participants will
complete a short quiz applicable to the psychoeducation and/or monitoring involved in their
condition in order to ensure comprehension of the materials. Reading the psychoeducation
materials, watching the video(s), and completing the quiz is expected to take participants
approximately 30 minutes.
Participants will have unlimited access to the handouts and videos through a web link for the
entire course of the study. Using REDCap, researchers will monitor the number of times each
participant accesses psychoeducation materials during the study.
Weekly Assessments All participants will complete weekly assessments of trauma symptoms,
threat appraisal, and safety behavior. Compliance with self-monitoring will be controlled for
in all analyses.
Weeks 4 and 8 Assessments At Week 4 and Week 8, participants will complete a comprehensive
assessment of all primary and secondary outcomes. Because the timing of onset of PTSD is
variable among patients (Frueh, Grubaugh, Yeager, & Magruder, 2009), PTSD diagnosis will be
assessed at Week 4 and Week 8. The psychoeducation quiz will also be administered at Weeks 4
and 8 to assess for comprehension and retention of the psychoeducational information.
Phone Interview The PSSI-5 interview will also be conducted over the phone for any
participants who screen positive for PTSD at Week 4 or Week 8 based on the PSSI-5 self-report
scale. The PSSI-5 phone interview will take approximately 20 minutes at each administration
and will be audio recorded in order to assess inter-rater reliability of PTSD diagnosis.
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