Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06119503
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peer-Delivered Episodic Future Thinking for Returning Citizens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-21', 'releaseDate': '2025-08-05'}], 'estimatedResultsFirstSubmitDate': '2025-08-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-22', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Delay Discounting 5 Trial Adjusted Measure', 'timeFrame': 'Baseline and up to 3 months post-intervention', 'description': 'The computer based adjusting amount discounting task uses an adjusting algorithm to determine the amount of immediately available money that is equivalent to a large sum that is delayed by seven discrete durations of time presented in a randomized order (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). At each delay, a choice is first presented between the delayed larger sum and a smaller sum available immediately. For each trial, the position of the delayed and immediate amounts are randomly assigned and the participant chooses the preferred option by pressing the corresponding response button.'}, {'measure': 'Change in Consideration of Future Consequences Scale', 'timeFrame': 'Baseline and up to 3 months post-intervention', 'description': "The Consideration of Future Consequences Scale1 (CFCS-14) is a 14-item self-report questionnaire that assesses active consideration of longer-term implications of an individual's actions. Lower scores on the CFCS-14 are associated with a greater focus on immediate needs and have been found to be associated with less engagement in health behaviors1819 and greater substance use. The measure has been used extensively among adult samples and demonstrates strong reliability and validity. Research suggests modest but significant correlations with the MCQ."}], 'secondaryOutcomes': [{'measure': 'Change in Short Michigan Alcohol Screening Test (SMAST)', 'timeFrame': 'Baseline and up to 3 months post-intervention', 'description': 'The SMAST is a brief questionnaire consisting of 13 items. It can be completed in just a few minutes and is designed for individuals with a reading level equivalent to that of a 7th grader. This assessment tool was derived from the Michigan Alcoholism Screening Test and has been found to be a reliable diagnostic tool to detect at-risk alcohol use, alcohol abuse, or alcoholism. The evaluation data suggests its effectiveness, with no notable occurrence of false positives.'}, {'measure': 'Change in Drug Abuse Screen Test (DAST)', 'timeFrame': 'Baseline and up to 3 months post-intervention', 'description': 'The DAST offer a concise self-report tool for screening populations, identifying clinical cases, and researching treatment effectiveness related to drug abuse. It is applicable for use with both adults and older adolescents. The DAST-10 provides a numerical gauge of the extent of drug abuse-related consequences. Administering the assessment takes around 5 minutes Condensed from its longer counterpart of 28 items, the DAST-10 comprises 10 self-report items.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['delay discounting', 'episodic future thinking', 'returning citizen', 'substance use recovery'], 'conditions': ['Behavior, Health']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zeng S, Minton TD. Jail Inmates in 2019. Bureau of Justice Statistics. Accessed July 15, 2022. https://bjs.ojp.gov/library/publications/jail-inmates-2019'}, {'type': 'BACKGROUND', 'citation': 'Loeffler CE, Nagin DS. The Impact of Incarceration on Recidivism. Annu Rev Criminol. 2022;5(1):133-152. doi:10.1146/annurev-criminol-030920-112506'}, {'type': 'BACKGROUND', 'citation': 'NIDA. Criminal Justice DrugFacts. National Institute on Drug Abuse. Published June 1, 2020. 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Subst Abuse Rehabil. 2018 Dec 27;10:1-12. doi: 10.2147/SAR.S183252. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD).\n\nThe main questions it aims to answer are:\n\n1. Determine preliminary implementation potential of the EFT intervention, including acceptability and feasibility of conducting the intervention.\n2. Examine the preliminary effectiveness of this approach, with a specific focus on patient outcomes, including changes in delay discounting, treatment retention, treatment motivation, and substance use.\n\nParticipants will be asked to participant in pre and post assessment questionnaires, participate in a single-episode brief intervention followed by tailored phone call follow-ups.', 'detailedDescription': "Returning citizens with substance use disorders (SUD) are at the greatest risk for overdose in the first two weeks following the transition from incarceration. Thus, the reentry period is of specific importance for ensuring individuals are engaged and retained in specialized intervention services. Individuals also face numerous, and highly impactful, decisions during this period. They are required to navigate complex tasks (finding employment, securing housing), often with limited financial and social supports. Of particular concern, recent research suggests that the reentry period, often characterized by instability and limited resources, may reinforce a decision-making approach that favors meeting immediate needs relative to engaging in long-term planning. This focus on attaining smaller but immediately available rewards relative to larger, delayed, rewards (known as delay discounting), in turn, has been associated with a number of negative health outcomes, including substance use and poor treatment outcomes (higher dropout and lower motivation). In other words, the reentry context may create an environment which reinforces individuals' tendencies to engage in short-term, reward-seeking behaviors (e.g. substance use, skipping treatment appointments) at a time when their decisions have highly significant consequences (relapse, recidivism). This study will examine the efficacy of implementing a low-cost, brief intervention (Episodic Future Thinking) targeting the reduction of delay discounting with the reentry population to inform broader public health efforts aimed at reducing substance misuse and improvements in treatment outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 18 years of age\n2. Experience in an incarceration setting within 12 months\n3. Identify as an individual in substance use recovery\n4. Willing to participate in the study\n5. Able to participate in written assessments and an intervention conducted in English\n6. Willing to receive brief bi-weekly check-in calls for one month, email, and other phone messages related to study participation including SMS/text messages as needed\n\nExclusion Criteria:\n\n1. Individuals' ineligible or unwilling to participate in study activities and assessments\n2. Self-reporting of active and untreated psychosis"}, 'identificationModule': {'nctId': 'NCT06119503', 'briefTitle': 'Peer-Delivered Episodic Future Thinking for Returning Citizens', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Peer Delivered Episodic Future Thinking to Improve MOUD Treatment Engagement Among Returning Citizens - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'JRCT: 16686-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elongating Time HOrizons for Reentry (ETHoR)', 'description': "Episodic Future Thinking (EFT) utilizes participant-generated descriptions of future events to elongate an individual's temporal horizon. In EFT paradigms, the participant is asked to create and envision vivid descriptions of specific, positively valanced, events that could happen in the future. Recent research suggests that directing EFTs to focus on specific goals (i.e. evoking images of oneself engaging in activities consistent with a desired future outcome) are associated with stronger decreases in undesirable health behaviors. Thus, as part of the ETHoR condition, participants will be asked to verbally describe and imagine four specific events reflecting positive activities in which the participant engages in substance and incarceration-free activities, corresponding to predetermined future timepoints. The PRC will encourage participants to include as many contextual and emotional details as possible.", 'interventionNames': ['Behavioral: Elongating Time HOrizons for Reentry (ETHoR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized Recent Thinking (ERT)', 'description': 'Individuals in the control group utilizes SET; an approach that controls for activation of episodic thinking but does not engage prospection (the hypothesized mechanism of episodic future thinking, future outcome) are associated with stronger decreases in undesirable health behaviors. Thus, as part of the SET condition, participants will be asked to verbally describe and imagine four current events reflecting positive activities in which the participant engages in substance and incarceration-free activities, corresponding to current experiences. The PRC will encourage participants to include as many contextual and emotional details as possible.', 'interventionNames': ['Behavioral: Standardized Episodic Thinking (SET)']}], 'interventions': [{'name': 'Elongating Time HOrizons for Reentry (ETHoR)', 'type': 'BEHAVIORAL', 'otherNames': ['Episodic Future Thinking (EFT)'], 'description': 'The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in an incarceration free future.', 'armGroupLabels': ['Elongating Time HOrizons for Reentry (ETHoR)']}, {'name': 'Standardized Episodic Thinking (SET)', 'type': 'BEHAVIORAL', 'description': 'In the standardized episodic thinking (SET) condition, the participant will instead describe in vivid details events that have occurred in the recent past.', 'armGroupLabels': ['Standardized Recent Thinking (ERT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48208', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Recovery Project', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Detroit Recovery Project INC', 'class': 'UNKNOWN'}, {'name': 'Michigan State University', 'class': 'OTHER'}, {'name': 'University of Kansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Julia Felton', 'investigatorAffiliation': 'Henry Ford Health System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-05', 'type': 'RELEASE'}, {'date': '2025-08-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Julia Felton, Principal Investigator, Henry Ford Health System'}}}}