Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Tonic Immobility Response
• Interventions: Behavioral: Tonic Immobility Psychoeducation (TIP); Behavioral: Health Education Training (HET)

• 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

Arm && Interventions

Group	Intervention	Description
Tonic Immobility Psychoeducation (TIP)	Tonic Immobility Psychoeducation (TIP)	Participants in the experimental condition will receive the TIP intervention.
Health Education Training (HET)	Health Education Training (HET)	Participants in the control condition will receive the HET intervention.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

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