Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 3:34 AM
Study NCT ID:
NCT05678361
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2018-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep's Influence on the Treatment of Intrusive Emotional
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Psychotherapists and outcome assessors are blind to participants' group membership (i.e., sleep versus wake after exposure therapy)"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician- assessed Posttraumatic stress symptom severity at 1 week', 'timeFrame': 'One week post- treatment', 'description': 'Clinician- assessed PTSD symptom severity (CAPS- 5)'}, {'measure': 'Self-reported Posttraumatic stress symptom severity at 1 week', 'timeFrame': 'One week post- treatment', 'description': 'Self - reported PTSD symptom severity (PCL-5)'}, {'measure': 'Clinician- assessed Posttraumatic stress symptom severity at 1 month', 'timeFrame': 'One month post- treatment', 'description': 'Clinician- assessed PTSD symptom severity (CAPS- 5)'}, {'measure': 'Self-reported Posttraumatic stress symptom severity at 1 month', 'timeFrame': 'One month post- treatment', 'description': 'Self - reported PTSD symptom severity (PCL-5)'}], 'secondaryOutcomes': [{'measure': 'Total sleep time', 'timeFrame': 'Immediately after written exposure therapy', 'description': 'Total sleep time according to EEG'}, {'measure': 'Time spent in N1 sleep', 'timeFrame': 'Immediately after written exposure therapy', 'description': 'N1 time according to EEG'}, {'measure': 'Time spent in N2 sleep', 'timeFrame': 'Immediately after written exposure therapy', 'description': 'N2 time according to EEG'}, {'measure': 'Time spent in N3 sleep', 'timeFrame': 'Immediately after written exposure therapy', 'description': 'N3 time according to EEG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'memory', 'consolidation'], 'conditions': ['Intrusive Memories', 'PTSD']}, 'descriptionModule': {'briefSummary': 'Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. The current study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.', 'detailedDescription': 'Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. However, not all patients benefit equally and only about 50% show sustained response. There is thus room for improvement in terms of (i) better understanding who benefits from this type of therapy and (ii) possible ways of augmenting existing trauma-focused therapies. The current study aims to contribute to these endevours. Specifically, the study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM V criteria of PTSD (at least moderate symptoms in two categories)\n* Currently receiving Written Exposure Therapy at one of the psychotherapy centers at the Psychiatric University Clinic (PUC).\n* Not more than moderate alcohol consumption (not more than 5 alcoholic drinks/week).\n* Ability to understand the study instructions\n\nExclusion Criteria:\n\n* Travel over \\> 3 time zones in \\< 3 months\n* head injury\n* shift work\n* current substance abuse\n* neurological disease\n* drug addiction\n* Current suicidality\n\nSpecific exclusion criteria for the fMRI:\n\n* Acute psychotic symptoms\n* Pregnancy\n* Claustrophobia\n* Magnetic resonance imaging incompatibility:\n* Cardiac pacemaker or other metallic implants (e.g. metallic cardiac valve, insulin pump)\n* Metallic foreign particles (e.g. after bullet wound, shell splinter, clips, metal prostheses)'}, 'identificationModule': {'nctId': 'NCT05678361', 'acronym': 'SLEPT', 'briefTitle': "Sleep's Influence on the Treatment of Intrusive Emotional", 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': "Sleep's Influence on the Treatment of Intrusive Emotional Memories With Trauma-focused CBT", 'orgStudyIdInfo': {'id': '2016-01357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep after exposure', 'description': 'Participants take a nap during 90 min following three exposure (WET) sessions.', 'interventionNames': ['Behavioral: Sleep/Nap']}, {'type': 'NO_INTERVENTION', 'label': 'Wake after exposure', 'description': 'Participants watch a 90 min documentary following three exposure (WET) sessions.'}], 'interventions': [{'name': 'Sleep/Nap', 'type': 'BEHAVIORAL', 'description': 'Participants sleep after a maximum of three sessions of exposure therapy.', 'armGroupLabels': ['Sleep after exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Psychiatric University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Birgit Kleim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Psychiatric University Hospital, Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}