Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Florida State University
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Guilt
Study Overview
Brief Summary
A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event.
Detailed Description
A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event. The investigators expect that this intervention will lead to improvement in posttraumatic guilt, shame, and PTSD symptoms as compared to an active control condition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The participant will be randomly assigned to the active or control condition. The participant will not be informed of which condition they are receiving until after completion of the study, at which point individuals in the control condition will be given access to the active intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Endorsed prior TI experience (TIQ items A & B)
- •Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)
Exclusion Criteria
- •Inability to consent or complete the intervention including:
- •Cognitive impairment
- •Uncorrected visual or auditory impairment
- •Unmedicated severe mental illness
- •Imminent risk of harm to self or others
Outcomes
Primary Outcomes
Guilt
Time Frame: post-intervention, on Day 1
Feelings of guilt as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes.
Shame
Time Frame: post-intervention, on Day 1
Feelings of shame as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes.
Posttraumatic Stress Disorder Symptoms
Time Frame: up to 1 month
PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item scale with values ranging from 0 to 4 for each item. Items are totaled for a total score ranging 0 to 80, with lower values indicating better outcomes.
Secondary Outcomes
No secondary outcomes reported
Investigators
Norman Schmidt
Distinguished Research Professor
Florida State University