Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention (TIP)
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|ClinicalTrials.gov Identifier: NCT05113277|
Recruitment Status : Completed
First Posted : November 9, 2021
Last Update Posted : June 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder Tonic Immobility Response||Behavioral: Tonic Immobility Psychoeducation (TIP) Behavioral: Health Education Training (HET)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned to complete 1 of 2 interventions - active or control.|
|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.|
|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|
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).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05113277
|United States, Florida|
|Anxiety and Behavioral Health Clinic|
|Tallahassee, Florida, United States, 32306|
|Principal Investigator:||Norman B Schmidt, PhD||Florida State University|