Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-27 @ 8:32 AM
Study NCT ID:
NCT03903159
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2019-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Piloting "Positive Peer Journaling" a Journaling Practice to Support Recovery From Addiction
Sponsor:
Organization:
Raw JSON
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PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Positive Peer Journaling (PPJ)\n\nPositive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. 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On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Percentage of participants who were retained in treatment at the host facility until the end of the study or who left the residential treatment facility on good terms during the course of the study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Substance Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Positive Peer Journaling (PPJ)\n\nPositive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. 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On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Total count of the number of PPJ journal entries made over the course of the study', 'unitOfMeasure': 'number of journal entries', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'Positive Peer Journaling (PPJ)\n\nPositive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Discharged with Staff Approval', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Discharged at Staff Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Discharged Against Staff Advice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'Positive Peer Journaling (PPJ)\n\nPositive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. 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On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-20', 'size': 3188489, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-02T11:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2019-01-18', 'resultsFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-02', 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Retention', 'timeFrame': '8 weeks', 'description': 'Percentage of participants who were retained in treatment at the host facility until the end of the study or who left the residential treatment facility on good terms during the course of the study.'}, {'measure': 'Substance Use', 'timeFrame': '8 weeks', 'description': 'Evidence that the individual used drugs or alcohol during the intervention period. This will be assessed via positive drug screen (urine test or breathalizer) or participant self-report of substance use. Reported as the number of participants who use illicit substances during the study.'}, {'measure': 'Percentage of Group Sessions Attended', 'timeFrame': '8 weeks', 'description': 'Percentage of group sessions will be calculated by taking the number of group sessions attended divided by total number of group sessions offered. Outcome is reported as the overall percentage of group attendance for all 15 participants combined.'}, {'measure': 'Number of PPJ Journal Entries Made', 'timeFrame': '8 weeks', 'description': 'Total count of the number of PPJ journal entries made over the course of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Addiction']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery. A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes. The primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use. The investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The host setting is a residential substance use disorder treatment facility the serves only women.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* minimum 18 years of age,\n* meet DSM-V criteria for past-year SUD as primary or secondary diagnosis,\n* English literacy sufficient to make short written lists needed to complete PPJ and homework assessments,\n* minimum 2 weeks sustained abstinence,\n* completed first 2 weeks of treatment at Wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site,\n* priority will go to participants who are from or moving back to a rural area or small town defined as a population less than 10,500,\n* agree to be audio recorded in group meetings and in individual meetings with research staff,\n* currently are clients in the Wayside residential program,\n* participants must be English speaking and literacy must be strong enough to write short lists and to understand the questions asked in the questionnaires.\n* Priority will go to women who will be residing at Wayside for the duration of the study activities (and not moving out after one week, for example).\n\nExclusion Criteria:\n\n* presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study;\n* severe psychiatric illness (current schizophrenia, major depression with suicidal ideation);\n* personality disorders that would interfere with satisfactory participation in or completion of the study protocol,\n* inability to give informed, voluntary consent to participate,\n* lack of sufficient English literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items,\n* any impairment, activity, or situation that in the judgement of the research staff would prevent satisfactory participation in or completion of the study protocol.'}, 'identificationModule': {'nctId': 'NCT03903159', 'acronym': 'PPJ', 'briefTitle': 'Piloting "Positive Peer Journaling" a Journaling Practice to Support Recovery From Addiction', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Addiction Recovery in a Rural Minnesota Community: Piloting "Positive Peer Journaling" Part II', 'orgStudyIdInfo': {'id': 'STUDY00004619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Group', 'description': 'Positive Peer Journaling (PPJ)', 'interventionNames': ['Behavioral: Positive Peer Journaling (PPJ)']}], 'interventions': [{'name': 'Positive Peer Journaling (PPJ)', 'type': 'BEHAVIORAL', 'description': 'PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': "Wayside Women's Treatment Center", 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}], 'overallOfficials': [{'name': 'Amy Krentzman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}