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Online Psychoeducation for the Prevention of PTSD

Primary Purpose

Psychoeducation on Trauma Reactions, Psychoeducation on Safety Behaviors and How to Fade Them, Monitoring-only Control

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducation on trauma reactions
Psychoeducation on safety behaviors
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychoeducation on Trauma Reactions focused on measuring Posttraumatic stress disorder, Safety behaviors, Threat appraisal, Secondary prevention, Internet-based, PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    No Intervention

    Arm Label

    PSYED-T

    PSYED-T+SB

    Monitoring-only control

    Arm Description

    In PSYED-T (psychoeducation on trauma symptoms), participants will receive a psychoeducation handout and watch a related video on common reactions to trauma. Participants in this condition will also receive a rationale stating that both learning about the nature of trauma reactions and monitoring symptoms are important for preventing development of PTSD.

    Participants in PSYED-T+SB (Combined psychoeducation on trauma reactions and safety behaviors) will receive psychoeducation handouts and videos on the nature of trauma symptoms and the nature of 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 and safety behaviors, learning to fade safety behaviors, and monitoring symptoms are important in the prevention of PTSD.

    The third condition will be a monitoring-only control and thus will receive no psychoeducation information. Participants in the control condition will receive a rationale that monitoring symptoms is important in the prevention of PTSD development.

    Outcomes

    Primary Outcome Measures

    PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
    PTSD diagnosis at Week 4 will be measured by the PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5).
    PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
    PTSD diagnosis at Week 8 will be measured by the PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5).
    PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
    PTSD diagnosis at Week 4 will be measured by the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Only participants who meet criteria for PTSD based on the PSS-SR-5 will be assessed.
    PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
    PTSD diagnosis at Week 8 will be measured by the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Only participants who meet criteria for PTSD based on the PSS-SR-5 will be assessed.
    PTSD Checklist for DSM-5 (PCL-5)
    Level of PTSD symptoms will be measured by the PTSD Checklist for DSM-5 (PCL-5).
    PTSD Safety Behavior Inventory (PSBI)
    The number of safety behaviors used will be measured by the PTSD Safety Behavior Inventory (PSBI).
    Posttraumatic Cognitions Inventory (PTCI)
    Level of threat appraisal will be measured by the Posttraumatic Cognitions Inventory (PTCI).

    Secondary Outcome Measures

    Life Events Checklist for DSM-5 (LEC-5)
    Type and experience of trauma occurring in the past 30 days will be measured by the Life Events Checklist for DSM-5 (LEC-5). Participants must select that one of the listed events has "Happened to me" in order to be eligible for this study.
    National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).
    Symptoms of Acute Stress Disorder as defined by the DSM-5 will be measured using the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).
    Acute Stress Disorder Scale (ASDS)
    Acute Stress Disorder as defined by the DSM-IV will be measured by the Acute Stress Disorder Scale (ASDS).
    Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
    Dissociation during the traumatic event will be measured by the Peritraumatic Dissociative Experiences Questionnaire (PDEQ).
    Credibility and Expectancy Questionnaire (CEQ)
    Credibility and expectancy of the intervention will be measured by selected items of the Credibility and Expectancy Questionnaire (CEQ).
    Trauma Coping Self-Efficacy scale (CSE-T)
    Perceived ability to cope with trauma-related situations will be measured by the Trauma Coping Self-Efficacy scale (CSE-T)
    Anxiety Sensitivity Index (ASI-3)
    Anxiety sensitivity will be measured by the Anxiety Sensitivity Index (ASI-3).
    Beck Depression Inventory (BDI-II)
    Depression will be measured by the Beck Depression Inventory (BDI-II).
    Alcohol Use Disorders Identification Test - Short Version (AUDIT-C)
    Drinking behaviors will be assessed with the AUDIT-C.
    Patient Health Questionnaire-9 (PHQ-9)
    Depressive symptoms will be assessed with the PHQ-9
    Generalized Anxiety Disorder 7-item scale (GAD-7)
    Symptoms of generalized anxiety disorder will be assessed with the GAD-7

    Full Information

    First Posted
    March 22, 2018
    Last Updated
    December 11, 2019
    Sponsor
    University of Texas at Austin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03496714
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Decision made to develop different intervention
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas at Austin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Participant
    Masking Description
    Participants will be told of the specifications only of the condition to which they are assigned.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PSYED-T
    Arm Type
    Active Comparator
    Arm Description
    In PSYED-T (psychoeducation on trauma symptoms), participants will receive a psychoeducation handout and watch a related video on common reactions to trauma. Participants in this condition will also receive a rationale stating that both learning about the nature of trauma reactions and monitoring symptoms are important for preventing development of PTSD.
    Arm Title
    PSYED-T+SB
    Arm Type
    Experimental
    Arm Description
    Participants in PSYED-T+SB (Combined psychoeducation on trauma reactions and safety behaviors) will receive psychoeducation handouts and videos on the nature of trauma symptoms and the nature of 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 and safety behaviors, learning to fade safety behaviors, and monitoring symptoms are important in the prevention of PTSD.
    Arm Title
    Monitoring-only control
    Arm Type
    No Intervention
    Arm Description
    The third condition will be a monitoring-only control and thus will receive no psychoeducation information. Participants in the control condition will receive a rationale that monitoring symptoms is important in the prevention of PTSD development.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation on trauma reactions
    Other Intervention Name(s)
    PSYED-T
    Intervention Description
    The psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation on safety behaviors
    Other Intervention Name(s)
    PSYED-SB
    Intervention Description
    The psychoeducation handout and video on safety behaviors will discuss safety behaviors that are common in PTSD and tips for how to eliminate them.
    Primary Outcome Measure Information:
    Title
    PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
    Description
    PTSD diagnosis at Week 4 will be measured by the PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5).
    Time Frame
    Week 4
    Title
    PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
    Description
    PTSD diagnosis at Week 8 will be measured by the PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5).
    Time Frame
    Week 8
    Title
    PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
    Description
    PTSD diagnosis at Week 4 will be measured by the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Only participants who meet criteria for PTSD based on the PSS-SR-5 will be assessed.
    Time Frame
    Week 4
    Title
    PTSD Symptom Scale Interview for DSM-5 (PSSI-5)
    Description
    PTSD diagnosis at Week 8 will be measured by the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Only participants who meet criteria for PTSD based on the PSS-SR-5 will be assessed.
    Time Frame
    Week 8
    Title
    PTSD Checklist for DSM-5 (PCL-5)
    Description
    Level of PTSD symptoms will be measured by the PTSD Checklist for DSM-5 (PCL-5).
    Time Frame
    Weekly change between baseline and Week 8
    Title
    PTSD Safety Behavior Inventory (PSBI)
    Description
    The number of safety behaviors used will be measured by the PTSD Safety Behavior Inventory (PSBI).
    Time Frame
    Weekly change between baseline and Week 8
    Title
    Posttraumatic Cognitions Inventory (PTCI)
    Description
    Level of threat appraisal will be measured by the Posttraumatic Cognitions Inventory (PTCI).
    Time Frame
    Weekly change between baseline and Week 8
    Secondary Outcome Measure Information:
    Title
    Life Events Checklist for DSM-5 (LEC-5)
    Description
    Type and experience of trauma occurring in the past 30 days will be measured by the Life Events Checklist for DSM-5 (LEC-5). Participants must select that one of the listed events has "Happened to me" in order to be eligible for this study.
    Time Frame
    Week 0
    Title
    National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).
    Description
    Symptoms of Acute Stress Disorder as defined by the DSM-5 will be measured using the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).
    Time Frame
    Week 0
    Title
    Acute Stress Disorder Scale (ASDS)
    Description
    Acute Stress Disorder as defined by the DSM-IV will be measured by the Acute Stress Disorder Scale (ASDS).
    Time Frame
    Week 0
    Title
    Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
    Description
    Dissociation during the traumatic event will be measured by the Peritraumatic Dissociative Experiences Questionnaire (PDEQ).
    Time Frame
    Week 0
    Title
    Credibility and Expectancy Questionnaire (CEQ)
    Description
    Credibility and expectancy of the intervention will be measured by selected items of the Credibility and Expectancy Questionnaire (CEQ).
    Time Frame
    Week 0
    Title
    Trauma Coping Self-Efficacy scale (CSE-T)
    Description
    Perceived ability to cope with trauma-related situations will be measured by the Trauma Coping Self-Efficacy scale (CSE-T)
    Time Frame
    Weekly change between baseline and Week 8
    Title
    Anxiety Sensitivity Index (ASI-3)
    Description
    Anxiety sensitivity will be measured by the Anxiety Sensitivity Index (ASI-3).
    Time Frame
    Week 0, Week 4, Week 8
    Title
    Beck Depression Inventory (BDI-II)
    Description
    Depression will be measured by the Beck Depression Inventory (BDI-II).
    Time Frame
    Week 0, Week 4, Week 8
    Title
    Alcohol Use Disorders Identification Test - Short Version (AUDIT-C)
    Description
    Drinking behaviors will be assessed with the AUDIT-C.
    Time Frame
    Weekly change between baseline and Week 8
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    Depressive symptoms will be assessed with the PHQ-9
    Time Frame
    Weekly change between baseline and Week 8
    Title
    Generalized Anxiety Disorder 7-item scale (GAD-7)
    Description
    Symptoms of generalized anxiety disorder will be assessed with the GAD-7
    Time Frame
    Weekly change between baseline and Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael J Telch, PhD
    Organizational Affiliation
    The University of Texas at Austin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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