Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-24 @ 4:00 AM
Study NCT ID:
NCT06680193
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effects of the Processing of Positive Memories Technique on Posttrauma Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily negative and positive affect levels', 'timeFrame': 'Each day for 21 days prior to and after the intervention and each survey references the past 24 hours', 'description': 'Daily Positive and Negative Affect are assessed by rating the extent of four positive (excited, cheerful, satisfied, relaxed) and six negative (stressed, irritated, anxious, sad, hopeless, insecure) emotions. This is adapted from the 20-item Positive and Negative Affect Scale. The total positive affect subscale score can range from 1 to 20, with higher scores reflecting more positive affect levels. The total negative affect subscale score can range from 1 to 30, with higher scores reflecting more negative affect.'}, {'measure': 'Daily positive events', 'timeFrame': 'Each day for 21 days prior to and after the intervention and each survey references the past 24 hours', 'description': 'Daily positive events is measured by 1 item which asked participants to think about the most positive event of the day and rate how pleasant it was. The score can range from 1 to 4, with higher scores reflecting that the event was more pleasant.'}, {'measure': 'Daily posttrauma cognitions', 'timeFrame': 'Each day for 21 days prior to and after the intervention and each survey references the past 24 hours', 'description': "A 9-item brief version of the Posttraumatic Cognitions Inventory (PTCI-9) will measure trauma-related thoughts/beliefs with the time frame modified to 'in the last 24 hours.' The total raw score can range from 1 to 63, with higher scores reflecting endorsement of more negative posttrauma cognitions."}, {'measure': 'Daily PTSD symptoms', 'timeFrame': 'Each day for 21 days prior to and after the intervention and each survey references the past 24 hours', 'description': "Daily-life version of the Primary Care-PTSD-5 screen (PC-PTSD-5) will assess daily PTSD symptoms with the time frame modified to 'in the last 24 hours.' The total score can range from 0 to 5, with higher scores reflecting endorsement of more PTSD symptoms."}, {'measure': 'Number of retrieved positive memories', 'timeFrame': 'Baseline survey approximately 4 weeks prior to the intervention', 'description': 'AMT assesses the number of retrieved positive memories by using five cue words followed by a prompt to recall a personally meaningful and specific memory of an event that took place within any 24-hour period. The total score could range from 0 to 5, with higher scores indicating more number of retrieved positive memories.'}, {'measure': 'Number of retrieved positive memories', 'timeFrame': '1 week after intervention sessions', 'description': 'AMT assesses the number of retrieved positive memories by using five cue words followed by a prompt to recall a personally meaningful and specific memory of an event that took place within any 24-hour period. The total score could range from 0 to 5, with higher scores indicating more number of retrieved positive memories.'}], 'secondaryOutcomes': [{'measure': 'Positive Emotion Dysregulation', 'timeFrame': 'Baseline survey approximately 4 weeks prior to the intervention', 'description': 'The Difficulties in Emotional Regulation Scale-Positive Emotions is a 13-item self-report measure that examines dysregulation of positive emotions. The total score could range from 1 to 65, with higher scores indicating more positive emotion dysregulation.'}, {'measure': 'Positive Emotion Dysregulation', 'timeFrame': '1 week after intervention sessions', 'description': 'The Difficulties in Emotional Regulation Scale-Positive Emotions is a 13-item self-report measure that examines dysregulation of positive emotions. The total score could range from 1 to 65, with higher scores indicating more positive emotion dysregulation.'}, {'measure': 'Positive Emotion Dysregulation', 'timeFrame': 'At each of the 4 weekly intervention sessions and each survey references the past week', 'description': 'The Difficulties in Emotional Regulation Scale-Positive Emotions is a 13-item self-report measure that examines dysregulation of positive emotions. The total score could range from 1 to 65, with higher scores indicating more positive emotion dysregulation.'}, {'measure': 'PTSD symptom severity', 'timeFrame': 'Baseline survey approximately 4 weeks prior to the intervention', 'description': 'The PTSD Checklist for DSM-5 is a 20-item self-report measure that will be used to evaluate PTSD symptom severity in relation to the worst trauma. The total score could range from 0 to 80, with higher scores reflecting more PTSD symptom severity.'}, {'measure': 'PTSD symptom severity', 'timeFrame': '1 week after intervention sessions', 'description': 'The PTSD Checklist for DSM-5 is a 20-item self-report measure that will be used to evaluate PTSD symptom severity in relation to the worst trauma. The total score could range from 0 to 80, with higher scores reflecting more PTSD symptom severity.'}, {'measure': 'PTSD symptom severity', 'timeFrame': 'At each of the 4 weekly intervention sessions and each survey references the past week', 'description': 'The PTSD Checklist for DSM-5 is a 20-item self-report measure that will be used to evaluate PTSD symptom severity in relation to the worst trauma. The total score could range from 0 to 80, with higher scores reflecting more PTSD symptom severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posttrauma Health', 'Positive Autobiographical Memories', 'Trauma'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '38214953', 'type': 'BACKGROUND', 'citation': 'Greene T, Contractor AA, Dicker-Oren SD, Fentem A, Sznitman SR. The Effects of the Processing of Positive Memories Technique on Posttrauma Affect and Cognitions Among Survivors of Trauma: Protocol for a Daily Diary Study. JMIR Res Protoc. 2024 Jan 12;13:e51838. doi: 10.2196/51838.'}, {'pmid': '41065062', 'type': 'DERIVED', 'citation': 'Rodenbaugh MM, Thompson LM, Sznitman SR, Jin L, Contractor AA. Refining processing of positive memories technique: client perspectives on components, format, and feasibility. Eur J Psychotraumatol. 2025 Dec;16(1):2563197. doi: 10.1080/20008066.2025.2563197. Epub 2025 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'The current study will examine daily-level impacts of a technique addressing positive memory retrieval on thoughts, feelings, and health among individuals with trauma experiences.', 'detailedDescription': "Post-traumatic stress disorder (PTSD) is primarily a memory encoding- and retrieval-based disorder. If untreated, there are significant physical, psychological, social, and economic impacts for an individual, their families, and the society broadly. Research demonstrates that positive memory processes contribute to the etiology and maintenance of PTSD symptoms. Indeed, difficulties in retrieving and discussing positive memories are amplified among individuals with PTSD. Further, interventions capitalizing on (positive) memory retrieval have been linked to enhanced psychological well-being.\n\nConsidering this literature, the Processing of Positive Memories Technique (PPMT) was developed as a promising new treatment approach for posttraumatic stress disorder (PTSD), which involves detailed narration and processing of specific positive autobiographical memories. This study uses an innovative research protocol that combines case-series design and daily diary approaches to the effects of PPMT on daily affect, daily cognitions, and daily PTSD symptoms. It is hypothesized that at the daily level, in comparison to their an individual's pre-PPMT levels, following the PPMT intervention, participants will report (1) a lower count of endorsed daily PTSD symptoms, (2) increases in daily positive affect and decreases in daily negative affect, (3) increases in positive affect reactivity to daily positive events, and (4) decreases in daily posttrauma cognitions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being aged between 18 and 65 years\n* endorsing a trauma with posttrauma symptoms\n* access to an electronic device with internet capabilities\n* working knowledge of English\n* being a current resident of the Dallas Fort Worth metroplex\n* willingness and availability to participate in approximately 10 weeks of this study (including 4 therapy sessions)\n* willingness to be video-recorded during sessions for quality control purposes\n\nExclusion Criteria:\n\n* active suicidal plan, suicidal attempt, homicidal plan, or homicidal attempt (past 3 months including current)\n* currently in therapy with a mental health provider'}, 'identificationModule': {'nctId': 'NCT06680193', 'acronym': 'PPMT', 'briefTitle': 'Therapeutic Effects of the Processing of Positive Memories Technique on Posttrauma Health', 'organization': {'class': 'OTHER', 'fullName': 'University of North Texas, Denton, TX'}, 'officialTitle': 'Daily Affect and Cognition Impacts of Processing of Positive Memories Technique (PPMT) in a Trauma-Exposed Community Sample', 'orgStudyIdInfo': {'id': 'IRB-21-420'}, 'secondaryIdInfos': [{'id': '2020017', 'type': 'OTHER_GRANT', 'domain': 'United States-Israel Binational Science Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Processing of Positive Memories Technique', 'description': 'PPMT was administered as a 4-session protocol in this arm.', 'interventionNames': ['Behavioral: Processing of Positive Memories Technique']}], 'interventions': [{'name': 'Processing of Positive Memories Technique', 'type': 'BEHAVIORAL', 'description': 'PPMT was administered weekly as a 4-session protocol. In session 1, participants receive psychoeducation on PTSD symptoms, an overview of PPMT, and are assessed for psychological symptoms. Sessions 1-4 involve the detailed processing of a salient positive autobiographical memory to elicit "values, affect, strengths, and thoughts" related to that positive memory. Homework assignments include listening to an audio recording of that memory, completing a "values, affect, strengths, and thoughts" log, and engaging in a behavioral activity. In session 4, the therapist also reviews psychological symptoms and addresses termination.', 'armGroupLabels': ['Processing of Positive Memories Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76201', 'city': 'Denton', 'state': 'Texas', 'country': 'United States', 'facility': 'University of North Texas', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'De-identified IPD will be shared in 2029 until 2034.', 'ipdSharing': 'YES', 'description': 'All de-identified IPD will be shared.', 'accessCriteria': 'De-identified IPD will be stored with limited access in a data repository. Any interested researchers will email the PIs and complete a data sharing contract. If the contract is approved by the PIs, data will be shared in a secure manner.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Texas, Denton, TX', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Haifa, Israel', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}