NCT05113277: TIP

Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

Completed NA Results posted Last updated 23 August 2024

What this trial tests

NA trial testing Tonic Immobility Psychoeducation (TIP) in Posttraumatic Stress Disorder in 51 participants. Completed in 31 May 2022.

Timeline

27 September 2021

Primary endpoint
31 March 2022

31 May 2022

Quick facts

Lead sponsor	Florida State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	51
Start date	27 September 2021
Primary completion	31 March 2022
Estimated completion	31 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Tonic Immobility Psychoeducation (TIP)
• Health Education Training (HET)

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
• Tonic Immobility Response — all drugs for Tonic Immobility Response →

Sponsor

Florida State University

Who can join

18 and older, any sex, with Posttraumatic Stress Disorder or Tonic Immobility Response. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Posttraumatic Stress Disorder Symptoms Primary · 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.

Group	Value	95% CI
Tonic Immobility Psychoeducation (TIP)	30.41	± 18.23
Health Education Training (HET)	31.93	± 18.33

Guilt Primary · 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.

Group	Value	95% CI
Tonic Immobility Psychoeducation (TIP)	6.6	± 2.94
Health Education Training (HET)	6.85	± 3.86

Shame Primary · 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.

Group	Value	95% CI
Tonic Immobility Psychoeducation (TIP)	6.80	± 2.80
Health Education Training (HET)	6.7	± 3.76

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of a brief web-based tonic immobility psychoeducation intervention among trauma-exposed adults: A randomized clinical trial.
   Morabito DM, Schmidt NB. · · 2023 · cited 2× · PMID 37467150 · DOI 10.1002/jts.22955