Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention (TIP)

• ClinicalTrials.gov Identifier: NCT05113277
• Recruitment Status: Completed
• First Posted: November 9, 2021
• Last Update Posted: June 16, 2022
• Sponsor: Florida State University
• Information provided by (Responsible Party): Norman Schmidt, Florida State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder; Tonic Immobility Response	Behavioral: Tonic Immobility Psychoeducation (TIP); Behavioral: Health Education Training (HET)	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
• 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.
• Primary Purpose: Treatment
• Official Title: Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
• Actual Study Start Date: September 27, 2021
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tonic Immobility Psychoeducation (TIP); Participants in the experimental condition will receive the TIP 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.
Placebo Comparator: Health Education Training (HET); Participants in the control condition will receive the HET intervention.	Behavioral: 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).

Outcome Measures

Primary Outcome Measures :

1. Posttraumatic Stress Disorder Symptoms [ Time Frame: up to 1 month ]
   PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5); Value range = 0 to 80 with lower values indicating better outcomes.
2. Guilt [ Time Frame: up to 1 month ]
   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.
3. Shame [ Time Frame: up to 1 month ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States, 32306

Sponsors and Collaborators

Florida State University

Investigators

• Principal Investigator: Norman B Schmidt, PhD; Florida State University

More Information

• Responsible Party: Norman Schmidt, Distinguished Research Professor, Florida State University
• ClinicalTrials.gov Identifier: NCT05113277
• Other Study ID Numbers: Morabito01
• First Posted: November 9, 2021
• Last Update Posted: June 16, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norman Schmidt, Florida State University:

Psychoeducation; Online Intervention

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders