Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

NCT ID: NCT05113277

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2022-05-31

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.

Conditions

Posttraumatic Stress Disorder; Tonic Immobility Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tonic Immobility Psychoeducation (TIP)

Participants in the experimental condition will receive the TIP intervention.

Group Type: EXPERIMENTAL

Tonic Immobility Psychoeducation (TIP)

Intervention Type: 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)

Participants in the control condition will receive the HET intervention.

Group Type: PLACEBO_COMPARATOR

Health Education Training (HET)

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Norman Schmidt

Distinguished Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman B Schmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Morabito01

Identifier Type: -

Identifier Source: org_study_id