Complex Post-Traumatic Stress DisorderNCT06007612
Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
A study testing Context Sensitivity in Emotion Regulation in people with Complex Post-Traumatic Stress Disorder, run by Gal Sheppes at 1 site in Israel.
Trial summary
This study will examine context sensitivity, composed of two sequential elements: (a) accurate classification of changing affective contextual demands, followed by (b) flexible selection of regulatory strategies that matches changing contextual demands, among complex PTSD vs. Healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- Context Sensitivity in Emotion Regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Apr 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Native Hebrew speakers
- age between 18 - 65
- normal or corrected to normal vision
- computer and internet access
- Group 1: Diagnosis of PTSD according to the DSM-5
- Group 2: GAD and PHQ scores (score<10), no diagnosis of PTSD according to the DSM-5
Who cannot join
- Psychosis
- substance dependence or abuse other than nicotine
- Neurological condition
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, 6997801
Gal Sheppes, PhD, 972-3-6408977, gsheppes@gmail.com
Naomi B Fine, PhD, 0528681031, naomifine@mail.tau.ac.il
About this study
This study will examine context sensitivity, composed of two sequential elements: (a) accurate classification of changing affective contextual demands, followed by (b) flexible selection of regulatory strategies that matches changing contextual demands, among complex PTSD vs. Healthy controls.
Read the detailed description
The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.
A compatibility check, filtering, verification of exclusion criteria and informed consent will occur via online self-report questionnaires.
Clinical questioners include:
Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder Questioner (GAD-7) - Anxiety Symptoms
Participants who pass the initial filtering, will be called and provided with an explanation about the study following which they received the online experiment.
Modified regulatory selection flexibility paradigm- included 3 blocks:
(A) Stimuli Classification- 80 emotional words (equally distributed between high or low intensities) are presented and participants are asked classify each emotional word to high or low intensity.
(B) Regulatory Selection- 40 emotional words (out of the 80 presented in block A) are presented and participants are instructed to behaviorally choose between distraction and reappraisal.
(B) Regulatory Selection- 40 emotional words (the 40 remaining from block A) are presented, prior to regulatory selection, participants received accurate normed intensity classification of the word and then participants are instructed to behaviorally choose between distraction and reappraisal.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- Context Sensitivity in Emotion Regulation
- Keywords
- EMOTION REGULATION
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Context Sensitivity in Emotion RegulationBehavioural
Context Sensitivity of affective intensities and its association to Emotion Regulation Flexibility Selection
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Context Sensitivity in Emotion Regulation | Experimental | Not described Receives: Behavioral: Context Sensitivity in Emotion Regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in accurate intensity classification measured during Block A of the experiment
comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.
Measured: During the experimental task (1 hour)
regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm
group comparison of the association between accuracy in intensity classification (as measured in Block A) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block B.
Measured: During the experimental task (1 hour)
regulatory selection flexibility (measured by distraction choice in high intensity minus distraction choice in low intensity) following provided intensity as assessed by regulatory selection paradigm
group comparison of the association between provided intensity classification (i.e., whether stimuli is of high or low intensity) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block C
Measured: During the experimental task (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start13 Apr 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 2 groups enrolled in a one-time behavioral paradigm
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gal Sheppes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gal Sheppes, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007612
- Sponsor's protocol ID
- Sheppes02
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06007612
- Acronym / sponsor ID
- Sheppes02
- Conditions
- Complex Post-Traumatic Stress Disorder
- Keywords
- EMOTION REGULATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Gal SheppesUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine context sensitivity, composed of two sequential elements: (a) accurate classification of changing affective contextual demands, followed by (b) flexible selection of regulatory strategies that matches changing contextual demands, among complex PTSD vs. Healthy controls.
Detailed description
The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.
A compatibility check, filtering, verification of exclusion criteria and informed consent will occur via online self-report questionnaires.
Clinical questioners include:
Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder Questioner (GAD-7) - Anxiety Symptoms
Participants who pass the initial filtering, will be called and provided with an explanation about the study following which they received the online experiment.
Modified regulatory selection flexibility paradigm- included 3 blocks:
(A) Stimuli Classification- 80 emotional words (equally distributed between high or low intensities) are presented and participants are asked classify each emotional word to high or low intensity.
(B) Regulatory Selection- 40 emotional words (out of the 80 presented in block A) are presented and participants are instructed to behaviorally choose between distraction and reappraisal.
(B) Regulatory Selection- 40 emotional words (the 40 remaining from block A) are presented, prior to regulatory selection, participants received accurate normed intensity classification of the word and then participants are instructed to behaviorally choose between distraction and reappraisal.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 groups enrolled in a one-time behavioral paradigm
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Context Sensitivity in Emotion Regulation | Experimental | Behavioral: Context Sensitivity in Emotion Regulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Native Hebrew speakers
- age between 18 - 65
- normal or corrected to normal vision
- computer and internet access
- Group 1: Diagnosis of PTSD according to the DSM-5
Key exclusion criteria (3 listed)
- Psychosis
- substance dependence or abuse other than nicotine
- Neurological condition
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 |
|---|---|---|
| Context Sensitivity in Emotion RegulationContext Sensitivity of affective intensities and its association to Emotion Regulation Flexibility Selection | Behavioural | Behavioral: Context Sensitivity in Emotion Regulation |
Primary outcome
Difference in accurate intensity classification measured during Block A of the experiment
Time frame: During the experimental task (1 hour)
comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.
regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm
Time frame: During the experimental task (1 hour)
group comparison of the association between accuracy in intensity classification (as measured in Block A) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block B.
regulatory selection flexibility (measured by distraction choice in high intensity minus distraction choice in low intensity) following provided intensity as assessed by regulatory selection paradigm
Time frame: During the experimental task (1 hour)
group comparison of the association between provided intensity classification (i.e., whether stimuli is of high or low intensity) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block C
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Context Sensitivity in Emotion Regulation in people with Complex Post-Traumatic Stress Disorder, run by Gal Sheppes at 1 site in Israel.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in accurate intensity classification measured during Block A of the experiment (time frame: During the experimental task (1 hour)). 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 28 Aug 2023.