Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT06943560
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2025-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotion Regulation Selection Flexibility Training for PTSD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-03-02', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline of the total score of the Sheehan Disabilities Scale (SDS)', 'timeFrame': 'Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment', 'description': 'A composite of three self-rated items measuring the extent to which three domains in participants lives are impaired. Each scale ranges between 0 ("not at all") to 10 ("very much"). The three items are averaged into a single dimensional measure of global functional impairment with scores ranging 0-10.'}, {'measure': 'Change from baseline of the total score of the Beck Depression Inventory (BDI)', 'timeFrame': 'Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment', 'description': 'A composite score of the 20 items (omitted suicidally item) thus ranging from 0-60'}, {'measure': 'Change from baseline of the total score of the Perceived Ability to Cope With Trauma (PACT) Scale', 'timeFrame': 'Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment', 'description': "a 20-item self-report measure of one's beliefs about their capabilities in managing post-trauma sequelae. Two scale scores have been derived: trauma focus (perceived ability to process the trauma), and forward focus (perceived ability to move beyond the trauma). A flexibility score may also be derived, which represents an individual's ability to adaptively use both types of focus."}], 'primaryOutcomes': [{'measure': 'Pre to Post improvement of emotion regulatory selection flexibility', 'timeFrame': 'Measurements at Baseline and immidiately post treatment', 'description': 'regulatory selection flexibility is calculated by subtracting adaptive choice from the maladaptive choice specifically by subtracting the proportion of distraction selection in the low intensity stimuli (maladaptive choice) from the proportion of distraction selection in the high intensity stimuli (adaptive choice).'}, {'measure': 'Change from baseline of the total score of the PTSD Checklist (PCL-5)', 'timeFrame': 'Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment', 'description': 'The PCL-5, is a 20-item PTSD Checklist for DSM-5. Scores can range from 0 to 80, with higher scores reflecting more PTSD symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EMOTION REGULATION'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'This clinical study will examine the efficacy of a novel intervention aimed at improving Regulatory Selection Flexibility and PTSD symptoms among adult individuals with PTSD symptoms, compared to a tight active control group.', 'detailedDescription': 'Regulatory Selection Flexibility is defined as the ability to select regulatory strategies according to differing situational demands (i.e., regulatory selection flexibility rule; distraction for high intensity vs reappraisal in low intensity). The main questions it aims to answer are: \\[1\\] Can PTSD individuals improve Regulatory Selection Flexibility \\[2\\] Does improved Regulatory Selection Flexibility associate to reduction in PTSD symptoms? Participants will be randomly assigned to either a Flexibility Training or a closely matched Active regulatory selection Control Training group. Participants in both groups will receive a novel online bi weekly seven session intervention which is matched on all aspects of the intervention except for the flexibility rule as follows, the intervention consists of three modules: (a) Psychoeducation; both groups receive information on regulatory strategies (distraction and reappraisal). The test group includes explicit psychoeducation on appropriate strategy selection according to the regulatory selection flexibility rule. (b) Computerized Regulatory Selection Task; both groups are exposed to high and low negative intensity emotional words and are asked to select a regulatory strategy. Only the test group receives the flexibility rule and its application via feedback. (c) Two homework task for between sessions. Both groups are instructed to choose two daily events and report which regulatory strategy they chose and implemented. The test group is instructed to choose a high and low intensity event and implement flexible selection. Each session begins with a brief overview on their home task, followed by corrective feedback in test group when necessary.\n\nPrimary outcome measures were acquired via the computerized assessment of Regulatory Selection Flexibility Paradigm and clinical questioners for PTSD symptoms pre, immediately post and at 3-month post intervention follow up.\n\nTo examine the efficacy of the regulatory selection intervention and its clinical effects, according to a-priori power analysis and expected drop out of 20%, 80 participants that meet me PTSD cutoff will be enrolled and randomly assigned to one of two conditions: Experimental group (Regulatory Selection Flexibility Training) or active control (Regulatory Selection without Flexibility Training).\n\nFollowing intervention, the investigators expect that (a) Both groups will show PTSD symptom reduction. (b) That relative to the active control group, the experimental group will show improvement in regulatory selection flexibility pre-to-post intervention, and (c) That relative to the active control group, the experimental group will show greater reduction in PTSD symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* native Hebrew speakers\n* age between 18 - 65\n* normal or corrected to normal vision\n* computer and internet access\n* fulfill screening criteria of DSM-V for PTSD\n\nExclusion Criteria:\n\n* Complex PTSD\n* Psychotic disorders\n* substance dependence or abuse other than nicotine\n* Neurological condition\n* suicidal ideation or attempt\n* change in psychotherapy or pharmacological treatment in the past 3 months.\n* Diagnosed/suspected personality Disorder\n* Cognitive impairments'}, 'identificationModule': {'nctId': 'NCT06943560', 'briefTitle': 'Emotion Regulation Selection Flexibility Training for PTSD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Emotion Regulation Selection Flexibility Training for PTSD Patients', 'orgStudyIdInfo': {'id': 'Sheppes01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regulatory selection Flexibility Training', 'interventionNames': ['Behavioral: Emotion Regulation Selection Flexibility Training']}, {'type': 'EXPERIMENTAL', 'label': 'Tight Active control Training', 'interventionNames': ['Behavioral: Emotion Regulation Active control Training']}], 'interventions': [{'name': 'Emotion Regulation Selection Flexibility Training', 'type': 'BEHAVIORAL', 'description': '7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on days without sessions. Psychoeducation includes information on selection of appropriate strategy according to the regulatory selection flexibility rule (i.e., distraction for high intensity vs reappraisal in low intensity). In the computerized task participants are exposed to emotional words and are asked to select a regulatory strategy in a flexible matter according to the regulatory selection flexibility rule, and receive feedback on whether they chose flexibly or not. Following , they are instructed to implement the chosen strategy. Homework includes choosing two daily events one of high intensity and a second one of low intensity, and describe which strategy they selected and how they implemented their chosen strategy according to the flexibility rule.', 'armGroupLabels': ['Regulatory selection Flexibility Training']}, {'name': 'Emotion Regulation Active control Training', 'type': 'BEHAVIORAL', 'description': 'All the interventional sections are similar to the experimental group except that in the control group we omit the regulatory selection rule that defines which strategy is compatible with which emotional situation.\n\n7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on the days without sessions. Psychoeducation explicitly included information on regulatory strategies (without the regulatory selection flexibility rule). In the computerized task participants are exposed to the same emotional words and are asked to choose freely a regulatory strategy (without the regulatory selection flexibility rule or feedback), and implement it. Homework includes choosing two daily events and selecting and implementing a regulatory strategy (without the regulatory selection flexibility rule).', 'armGroupLabels': ['Tight Active control Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6997801', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gal Sheppes, PhD', 'role': 'CONTACT', 'email': 'gsheppes@gmail.com'}, {'name': 'Naomi Fine, PhD', 'role': 'CONTACT', 'email': 'naomifine@mail.tau.ac.il', 'phone': '0528681031'}], 'facility': 'Tel Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Gal Sheppes, PhD', 'role': 'CONTACT', 'email': 'gsheppes@gmail.com', 'phone': '0528681031'}, {'name': 'Naomi Fine, PhD', 'role': 'CONTACT', 'email': 'naomifine@mail.tau.ac.il', 'phone': '0528681031'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator of Emotion Regulation Lab', 'investigatorFullName': 'Gal Sheppes', 'investigatorAffiliation': 'Tel Aviv University'}}}}