Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

Posttraumatic Stress Disorder Clinical Trial

— TIP  

Official title:

Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113277
• Other study ID #: Morabito01
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Tonic Immobility Psychoeducation (TIP)
TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments.
• Health Education Training (HET)
The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms).

Locations

Country	Name	City	State
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posttraumatic Stress Disorder Symptoms	PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5); Value range = 0 to 80 with lower values indicating better outcomes.	up to 1 month
Primary	Guilt	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.	up to 1 month
Primary	Shame	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.	up to 1 month