Posttraumatic Stress DisorderTIPNCT05113277
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
A study testing Tonic Immobility Psychoeducation (TIP) and Health Education Training (HET) in people with Posttraumatic Stress Disorder and Tonic Immobility Response, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Tonic Immobility Response
- What is being tested?
- Tonic Immobility Psychoeducation (TIP) and Health Education Training (HET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Endorsed prior TI experience (TIQ items A \& B)
- Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32306
About this study
Official title: Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
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.
Read the 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.
- Being tested
- Tonic Immobility Psychoeducation (TIP), Health Education Training (HET)
- Keywords
- Psychoeducation, Online Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Immobility Response, Tonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonic Immobility Psychoeducation (TIP)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Experimental | Participants in the experimental condition will receive the TIP intervention. Receives: Behavioral: Tonic Immobility Psychoeducation (TIP) |
| Health Education Training (HET) | Placebo comparator | Participants in the control condition will receive the HET intervention. Receives: Behavioral: Health Education Training (HET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Symptoms
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.
Measured: up to 1 month
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.
Measured: post-intervention, on Day 1
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.
Measured: post-intervention, on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start27 Sep 2021
- Primary completion31 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
- Investigators
- Norman B Schmidt, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113277
- Sponsor's protocol ID
- Morabito01
- Acronym
- TIP
- Status last verified
- Apr 2024
- First submitted
- 27 Sep 2021
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT05113277
- Acronym / sponsor ID
- TIP / Morabito01
- Keywords
- Psychoeducation, Online Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
| Arm | Type | Receives |
|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Experimental | Behavioral: Tonic Immobility Psychoeducation (TIP)Participants in the experimental condition will receive the TIP intervention. |
| Health Education Training (HET) | Placebo comparator | Behavioral: Health Education Training (HET)Participants in the control condition will receive the HET intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Endorsed prior TI experience (TIQ items A \& B)
- Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)
Key exclusion criteria (5 listed)
- Cognitive impairment
- Uncorrected visual or auditory impairment
- Unmedicated severe mental illness
- Imminent risk of harm to self or others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Tonic Immobility Psychoeducation (TIP) |
| 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). | Behavioural | Health Education Training (HET) |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman B Schmidt, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonic Immobility Psychoeducation (TIP) and Health Education Training (HET) in people with Posttraumatic Stress Disorder and Tonic Immobility Response, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Symptoms (time frame: up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.