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

Primary Purpose

Posttraumatic Stress Disorder, Tonic Immobility Response

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tonic Immobility Psychoeducation (TIP)
Health Education Training (HET)
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Psychoeducation, Online Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anxiety and Behavioral Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tonic Immobility Psychoeducation (TIP)

Health Education Training (HET)

Arm Description

Participants in the experimental condition will receive the TIP intervention.

Participants in the control condition will receive the HET intervention.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
June 15, 2022
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT05113277
Brief Title
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
Acronym
TIP
Official Title
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Tonic Immobility Response
Keywords
Psychoeducation, Online Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
Masking
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.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tonic Immobility Psychoeducation (TIP)
Arm Type
Experimental
Arm Description
Participants in the experimental condition will receive the TIP intervention.
Arm Title
Health Education Training (HET)
Arm Type
Placebo Comparator
Arm Description
Participants in the control condition will receive the HET intervention.
Intervention Type
Behavioral
Intervention Name(s)
Tonic Immobility Psychoeducation (TIP)
Intervention Description
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
Intervention Name(s)
Health Education Training (HET)
Intervention Description
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 Outcome Measure Information:
Title
Posttraumatic Stress Disorder Symptoms
Description
PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5); Value range = 0 to 80 with lower values indicating better outcomes.
Time Frame
up to 1 month
Title
Guilt
Description
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.
Time Frame
up to 1 month
Title
Shame
Description
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.
Time Frame
up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman B Schmidt, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety and Behavioral Health Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

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