Clinical trial NCT03496714: Online Psychoeducation for the Prevention of PTSD
Official title: Fading Safety Behaviors in an Internet-Based Secondary Prevention for Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psychoeducation on Trauma Reactions
Psychoeducation on Safety Behaviors and How to Fade Them
Monitoring-only Control
Keywords: Posttraumatic stress disorder
Safety behaviors
Threat appraisal
Secondary prevention
Internet-based
PTSD
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 above. All three conditions will complete the same schedule of assessments.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Have regular access to the internet and email for eight weeks
* Have experienced a Criterion A trauma within the past 30 days, as assessed by the Life Events Checklist for DSM-5 (LEC-5; Weathers et al., 2013a)

Exclusion Criteria:

* Psychotic symptoms within the past six months, as measured by Psychiatric Diagnostic Screening Questionnaire (PDSQ) psychosis subscale
* Current suicidal intent, as measured by Beck Depression Inventory (BDI-II) suicidality item
* Immediate risk to others
* Have experienced a traumatic brain injury or other serious neurocognitive impairment in the past six months.
* Prior history of PTSD

Primary outcomes:
measure: PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
timeFrame: Week 4
measure: PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
timeFrame: Week 8
measure: PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
timeFrame: Week 4
measure: PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
timeFrame: Week 8
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Weekly change between baseline and Week 8
measure: PTSD Safety Behavior Inventory (PSBI)
timeFrame: Weekly change between baseline and Week 8
measure: Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Weekly change between baseline and Week 8
Secondary outcomes:
measure: Life Events Checklist for DSM-5 (LEC-5)
timeFrame: Week 0
measure: National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).
timeFrame: Week 0
measure: Acute Stress Disorder Scale (ASDS)
timeFrame: Week 0
measure: Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
timeFrame: Week 0
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Week 0
measure: Trauma Coping Self-Efficacy scale (CSE-T)
timeFrame: Weekly change between baseline and Week 8
measure: Anxiety Sensitivity Index (ASI-3)
timeFrame: Week 0, Week 4, Week 8
measure: Beck Depression Inventory (BDI-II)
timeFrame: Week 0, Week 4, Week 8
measure: Alcohol Use Disorders Identification Test - Short Version (AUDIT-C)
timeFrame: Weekly change between baseline and Week 8
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Weekly change between baseline and Week 8
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Weekly change between baseline and Week 8
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas at Austin
name: Michael J Telch, PhD
role: PRINCIPAL_INVESTIGATOR
References: