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Completed

NCT Number: NCT05113277

Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

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.

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Key information

Conditions

Posttraumatic Stress Disorder Behavior Behavior, Animal Immobility Response, Tonic Mental Disorders Motor Activity Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Tonic Immobility Response Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonic Immobility Psychoeducation (TIP)

Behavioral

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)

Behavioral

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).

Primary outcomes

  1. Posttraumatic Stress Disorder Symptoms

    Time frame: 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.

  2. Guilt

    Time frame: 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.

  3. Shame

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Acronym: TIP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2021
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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