Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05113277
Other study ID # Morabito01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2021
Est. completion date May 31, 2022

Study information

Verified date June 2022
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date May 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


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.
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).

Locations

Country Name City State
United States Anxiety and Behavioral Health Clinic Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 1 month
Primary 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. up to 1 month
Primary 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. up to 1 month
See also
  Status Clinical Trial Phase
Completed NCT03384706 - A Comparison of CPT Versus ART Versus WL N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Completed NCT00644423 - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT02989987 - NET for SGBV Survivors in Eastern DR Congo N/A
Completed NCT02320799 - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya N/A
Recruiting NCT02293291 - Thermal Clinic Treatment in Gulf War Illness Phase 1/Phase 2
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A
Completed NCT02720497 - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01693978 - Contingency Outcomes in Prolonged Exposure N/A
Completed NCT01469754 - Longitudinal Survey Analysis in Lymphoma Survivors N/A
Terminated NCT01239173 - Emotional Memory Reactivation in Posttraumatic Stress Disorder Phase 3
Completed NCT02362477 - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD Phase 3
Completed NCT01518972 - Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder Phase 2