Psychoeducation on Trauma ReactionsNCT03496714
Online Psychoeducation for the Prevention of PTSD
A study testing Psychoeducation on trauma reactions and Psychoeducation on safety behaviors in people with Psychoeducation on Trauma Reactions and Psychoeducation on Safety Behaviors and How to Fade Them, run by University of Texas at Austin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychoeducation on Trauma Reactions, Psychoeducation on Safety Behaviors and How to Fade Them, Monitoring-only Control
- What is being tested?
- Psychoeducation on trauma reactions and Psychoeducation on safety behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Psychoeducation on Trauma Reactions, Psychoeducation on Safety Behaviors and How to Fade Them, Monitoring-only Control
- Being tested
- Psychoeducation on trauma reactions, Psychoeducation on safety behaviors
- Keywords
- Posttraumatic stress disorder, Safety behaviors, Threat appraisal, Secondary prevention, Internet-based, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation on trauma reactionsBehavioural
Also called PSYED-T
The psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma.
Psychoeducation on safety behaviorsBehavioural
Also called PSYED-SB
The psychoeducation handout and video on safety behaviors will discuss safety behaviors that are common in PTSD and tips for how to eliminate them.
| Study group | Role | What they receive |
|---|---|---|
| PSYED-T | Active comparator | 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. Receives: Behavioral: Psychoeducation on trauma reactions |
| PSYED-T+SB | Experimental | 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. Receives: Behavioral: Psychoeducation on trauma reactions; Behavioral: Psychoeducation on safety behaviors |
| Monitoring-only control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 4
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).
Measured: Week 8
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.
Measured: Week 4
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.
Measured: Week 8
PTSD Checklist for DSM-5 (PCL-5)
Level of PTSD symptoms will be measured by the PTSD Checklist for DSM-5 (PCL-5).
Measured: Weekly change between baseline and Week 8
PTSD Safety Behavior Inventory (PSBI)
The number of safety behaviors used will be measured by the PTSD Safety Behavior Inventory (PSBI).
Measured: Weekly change between baseline and Week 8
Posttraumatic Cognitions Inventory (PTCI)
Level of threat appraisal will be measured by the Posttraumatic Cognitions Inventory (PTCI).
Measured: Weekly change between baseline and Week 8
Secondary outcomes (11)
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.
Measured: Week 0
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).
Measured: Week 0
Acute Stress Disorder Scale (ASDS)
Acute Stress Disorder as defined by the DSM-IV will be measured by the Acute Stress Disorder Scale (ASDS).
Measured: Week 0
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
Dissociation during the traumatic event will be measured by the Peritraumatic Dissociative Experiences Questionnaire (PDEQ).
Measured: Week 0
Credibility and Expectancy Questionnaire (CEQ)
Credibility and expectancy of the intervention will be measured by selected items of the Credibility and Expectancy Questionnaire (CEQ).
Measured: Week 0
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)
Measured: Weekly change between baseline and Week 8
Anxiety Sensitivity Index (ASI-3)
Anxiety sensitivity will be measured by the Anxiety Sensitivity Index (ASI-3).
Measured: Week 0, Week 4, Week 8
Beck Depression Inventory (BDI-II)
Depression will be measured by the Beck Depression Inventory (BDI-II).
Measured: Week 0, Week 4, Week 8
Alcohol Use Disorders Identification Test - Short Version (AUDIT-C)
Drinking behaviors will be assessed with the AUDIT-C.
Measured: Weekly change between baseline and Week 8
Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed with the PHQ-9
Measured: Weekly change between baseline and Week 8
Generalized Anxiety Disorder 7-item scale (GAD-7)
Symptoms of generalized anxiety disorder will be assessed with the GAD-7
Measured: Weekly change between baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Why it stopped: Decision made to develop different intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychoeducation on Trauma ReactionsStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496714
- Sponsor's protocol ID
- 2017-11-0001
- Status last verified
- Dec 2019
- First submitted
- 22 Mar 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fading Safety Behaviors in an Internet-Based Secondary Prevention for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03496714
- Acronym / sponsor ID
- 2017-11-0001
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision made to develop different intervention
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| PSYED-T | Active comparator | Behavioral: Psychoeducation on trauma reactionsIn 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. |
| PSYED-T+SB | Experimental | Behavioral: Psychoeducation on trauma reactions, Behavioral: Psychoeducation on safety behaviorsParticipants 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. |
| Monitoring-only control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation on trauma reactionsAlso: PSYED-TThe psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma. | Behavioural | PSYED-T, PSYED-T+SB |
| Psychoeducation on safety behaviorsAlso: PSYED-SBThe psychoeducation handout and video on safety behaviors will discuss safety behaviors that are common in PTSD and tips for how to eliminate them. | Behavioural | PSYED-T+SB |
Primary outcome
PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5)
Time frame: Week 4
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)
Time frame: Week 8
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)
Time frame: Week 4
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)
Time frame: Week 8
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)
Time frame: Weekly change between baseline and Week 8
Level of PTSD symptoms will be measured by the PTSD Checklist for DSM-5 (PCL-5).
PTSD Safety Behavior Inventory (PSBI)
Time frame: Weekly change between baseline and Week 8
The number of safety behaviors used will be measured by the PTSD Safety Behavior Inventory (PSBI).
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Weekly change between baseline and Week 8
Level of threat appraisal will be measured by the Posttraumatic Cognitions Inventory (PTCI).
11 secondary outcomes
Life Events Checklist for DSM-5 (LEC-5)
Time frame: Week 0
National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS-ASD).
Time frame: Week 0
Acute Stress Disorder Scale (ASDS)
Time frame: Week 0
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
Time frame: Week 0
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Week 0
Trauma Coping Self-Efficacy scale (CSE-T)
Time frame: Weekly change between baseline and Week 8
Anxiety Sensitivity Index (ASI-3)
Time frame: Week 0, Week 4, Week 8
Beck Depression Inventory (BDI-II)
Time frame: Week 0, Week 4, Week 8
Alcohol Use Disorders Identification Test - Short Version (AUDIT-C)
Time frame: Weekly change between baseline and Week 8
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Weekly change between baseline and Week 8
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Weekly change between baseline and Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Telch, PhD principal investigator
The University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation on trauma reactions and Psychoeducation on safety behaviors in people with Psychoeducation on Trauma Reactions and Psychoeducation on Safety Behaviors and How to Fade Them, run by University of Texas at Austin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Scale Self-Report for DSM-5 (PSS-SR-5) (time frame: Week 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.