Nctid:
NCT06223191
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019966", "term"=>"Substance-Related Disorders"}], "ancestors"=>[{"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M21837", "name"=>"Substance-Related Disorders", "asFound"=>"Substance Use Disorders", "relevance"=>"HIGH"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M11140", "name"=>"Lorazepam", "relevance"=>"LOW"}, {"id"=>"M7167", "name"=>"Diazepam", "relevance"=>"LOW"}, {"id"=>"M16595", "name"=>"Thiamine", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"T464", "name"=>"Thiamin", "relevance"=>"LOW"}, {"id"=>"T465", "name"=>"Thiamine", "relevance"=>"LOW"}, {"id"=>"T469", "name"=>"Vitamin B1", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Anticonvulsants", "abbrev"=>"AntiConv"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Adjuvants, Anesthesia", "abbrev"=>"AdjAn"}, {"name"=>"Muscle Relaxants, Central", "abbrev"=>"MuRelCen"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>150}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2024-09-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-23", "studyFirstSubmitDate"=>"2023-12-21", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-22", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Hospital Readmission Rate", "timeFrame"=>"3 months", "description"=>"Measurement of the readmissions rate at 3 months from the study's initiation. This could be a key indicator to assess the impact of interventions on relapse prevention."}, {"measure"=>"Risk Rate of Readmission", "timeFrame"=>"3 months", "description"=>"Measurement of the risk rate through the ratio of the readmission rate treatment group and the control group rate"}], "secondaryOutcomes"=>[{"measure"=>"HADS Score", "timeFrame"=>"3 months", "description"=>"Assessment of the presence of depressive and anxious symptoms in patients with substance use. Through HADS ScaleThis primary outcome would directly address the participants' mental health as a result of the interventions."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Substance Use Disorders", "Substance Withdrawal"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this clinical trial is to assess the effectiveness of Brief Negotiated Interview (BNI) in comparison to Narrative Therapy and Standard Care in reducing readmissions among male patients aged 18 and above with a history of substance use disorder The main questions it aims to answer is: Does the Brief Negotiated Interview reduces rehospitalization rates at least to 50%? Participants will be submitted to a Structured interview with motivational interviewing techniques. Researchers will compare 2 control groups one with standards of care and the other one with a narrative interview to see if they reduce readmission.", "detailedDescription"=>"The research investigates the effectiveness of the Brief Negotiated Interview (BNI) compared to Narrative Interview and Standards of Care in reducing readmissions among patients with Substance Use Disorder (SUD) in the Alcoholic Detoxification Unit of Santa Rosita Psychiatric Specialties Hospital in 2024. Employing a randomized clinical trial design, the study aims to address a critical gap in understanding the optimal intervention for this vulnerable population.\n\nStudy Design: This trial adopts a prospective, randomized, three-arm design, with participants randomly assigned to one of three groups: BNI, Narrative Interview, or Standard Care. The randomization process utilizes a computer-generated list, ensuring an allocation ratio of 1:1:1. The trial encompasses a recruitment period of three months, followed by a three-month follow-up period.\n\nParticipants: The target population comprises 150 male patients aged 18 or older admitted to the Alcoholic Detoxification Unit during January 2024.\n\nInterventions:\n\nBrief Negotiated Interview (BNI): Modeled after motivational interviewing techniques, BNI aims to empower patients to explore reasons for change. Administered as a single 30-minute session, BNI encourages patient autonomy in decision-making regarding behavioral changes related to substance use.\n\nNarrative Interview: A 20-minute session applying narrative therapy techniques, encouraging patients to explore and reframe their stories concerning substance use. The session emphasizes externalizing issues and examining social and political factors contributing to the problem.\n\nStandard Care: Following the Alcohol Detoxification Management Protocol, standard care includes pharmacological interventions (benzodiazepines, thiamine, etc.), psychological evaluation on the third day, psychoeducational sessions, and psychiatric assessment for dual diagnoses.\n\nOutcomes: Primary outcomes involve measuring rehospitalization rates at three months, time to relapse, reduction in substance consumption, and changes in depressive and anxious symptoms.\n\nStatistical Analysis:Descriptive statistics will characterize nominal and categorical variables. For continuous variables, means and standard deviations will be calculated. Chi-square tests will assess the relationship between rehospitalization and intervention groups. Risk ratios and incidence rates will be computed to determine the relative risk of readmission.\n\nEthical Considerations: The study adheres to CONSORT guidelines, receiving approval from the Institutional Review Board. Informed consent is obtained from all participants, ensuring comprehension of the study's purpose, risks, and benefits. Confidentiality is maintained, and participants are informed of their right to withdraw without interference in their clinical care.\n\nConclusion: This comprehensive research design integrates rigorous methodology, ethical considerations, and a tailored intervention approach to address the multifaceted challenges faced by patients with SUD. The outcomes are expected to contribute valuable insights to the field, guiding evidence-based practices for enhanced patient outcomes and reduced readmission rates"}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male patients aged 18 or older who are hospitalized in the Alcohol Detoxification Unit during the period of January to March of 2024\n* Patients with a score on the AUDIT scale greater than 15.\n* Patients with a score equal to or greater than 4 for any substance on the World Health Organization-ASSIST.\n* Patients from the Alcohol Detoxification Unit who provide their consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with a score on the AUDIT scale less than 15.\n* Patients with a score on the WHO-ASSIST scale for substances less than 4.\n* Patients from the Alcohol Detoxification Unit who do not provide their consent to participate in the study.\n* Patients from the Alcohol Detoxification Unit diagnosed with Delirium Tremens, Acute Intoxication of any substance, or conditions that alter consciousness.\n* Patients from the Alcohol Detoxification Unit diagnosed with intellectual disability documented in the medical records.\n* Female patients."}, "identificationModule"=>{"nctId"=>"NCT06223191", "briefTitle"=>"Reducing Readmissions: BNI Trial in Substance Use Disorder", "organization"=>{"class"=>"OTHER", "fullName"=>"Universidad Nacional Autonoma de Honduras"}, "officialTitle"=>"Comparing Brief Negotiated Interview, Narrative Interview, and Standard Care to Reduce Readmission: A 2024 Clinical Trial in Substance Use Disorder Patients at Santa Rosita Psychiatric Specialties Hospital", "orgStudyIdInfo"=>{"id"=>"BNIReadmissions"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Brief Negotiated Interview", "description"=>"The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. Instead of telling the patient what changes he/she should make, the BNI is intentionally designed to elicit reasons for change and action steps from the patient. It gives the patient voice and choice, making any potential behavior changes all the more empowering to the patient.", "interventionNames"=>["Other: Brief Negotiated Interview"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Narrative Interview", "description"=>"The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions.", "interventionNames"=>["Other: Narrative Interview"]}, {"type"=>"NO_INTERVENTION", "label"=>"Standards of Care", "description"=>"This arm includes the use of benzodiazepines (Diazepam or Lorazepam) when CIWA-Ar scale is ≥9. Other medications may include Thiamine, Potassium Chloride, oral rehydration salts, parenteral fluids, antiemetics, and gastric protectants if medically necessary. Patients undergo a psychological evaluation on the third day of admission. All patients receive at least one psychoeducational session on alcohol and substance use during their hospitalization. Psychiatric evaluation is available for those with dual diagnoses such as mood disorders, anxiety disorders, psychotic disorders, or multiple substance use. The total hospitalization time in the ward is 8 days."}], "interventions"=>[{"name"=>"Brief Negotiated Interview", "type"=>"OTHER", "description"=>"The BNI is a specialized \"brief intervention\" for the medical setting, has foundations in motivational interviewing techniques. The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. The BNI is in the form of an algorithm, or \"script\", that guides providers through the health intervention with carefully phrased key questions and responses, all at the providers' fingertips", "armGroupLabels"=>["Brief Negotiated Interview"]}, {"name"=>"Narrative Interview", "type"=>"OTHER", "description"=>"The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions.", "armGroupLabels"=>["Narrative Interview"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Tegucigalpa", "state"=>"Francisco Morazan", "country"=>"Honduras", "facility"=>"Facultad de Ciencias Medicas", "geoPoint"=>{"lat"=>14.0818, "lon"=>-87.20681}}], "overallOfficials"=>[{"name"=>"Carlos M. Rosales, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Universidad Nacional Autonoma de Honduras"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Universidad Nacional Autonoma de Honduras", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Carlos Manuel Rosales Gomez", "investigatorAffiliation"=>"Universidad Nacional Autonoma de Honduras"}}}}
