Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Tonic Immobility Response

• Registration Number: NCT05113277
• Lead Sponsor: Florida State University

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 Timeline

• Study Start: 2021-09-27
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-09
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-31
• Results First Submitted: 2022-12-05
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Results First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Posttraumatic Stress Disorder Symptoms	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.
Guilt	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	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.

Trial Locations

Locations (1)

Anxiety and Behavioral Health Clinic; 🇺🇸 Tallahassee, Florida, United States