Nctid:
NCT06614842
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000013313", "term"=>"Stress Disorders, Post-Traumatic"}], "ancestors"=>[{"id"=>"D000040921", "term"=>"Stress Disorders, Traumatic"}, {"id"=>"D000068099", "term"=>"Trauma and Stressor Related Disorders"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "relevance"=>"LOW"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "relevance"=>"LOW"}, {"id"=>"M7060", "name"=>"Depressive Disorder, Major", "relevance"=>"LOW"}, {"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "asFound"=>"Mental Disorders", "relevance"=>"HIGH"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M16103", "name"=>"Stress Disorders, Post-Traumatic", "asFound"=>"Stress Disorders, Post-Traumatic", "relevance"=>"HIGH"}, {"id"=>"M24916", "name"=>"Stress Disorders, Traumatic", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M222", "name"=>"Trauma and Stressor Related Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Therapeutic Alliance Scale", "timeFrame"=>"At conclusion of therapy after 6 weeks.", "description"=>"Measure of patient-therapist alliance during therapy"}], "primaryOutcomes"=>[{"measure"=>"Generalized Anxiety Disorder-7 Screener", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of anxiety symptoms"}, {"measure"=>"Patient Health Questionnaire-9 Screener", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of depressive symptoms"}, {"measure"=>"PTSD Checklist-5", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of post-traumatic stress symptoms"}, {"measure"=>"Yale-Brown Obsessive Compulsive Scale", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of obsessive compulsive disorder symptoms"}, {"measure"=>"Alcohol Use Disorders Identification Test", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of concerning alcohol use"}, {"measure"=>"National Institute of Drug Abuse Modified Alcohol, Smoking, and Substance Involvement Screening Test", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of substance use"}], "secondaryOutcomes"=>[{"measure"=>"Life Quality Scale", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of life quality"}, {"measure"=>"Experiential Avoidance Rating Scale", "timeFrame"=>"At enrollment and at the end of treatment at 6 weeks", "description"=>"Measure of experiential avoidance"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["common factors psychotherapy"], "conditions"=>["Major Depression", "Generalized Anxiety", "Stress Disorder, Post Traumatic", "Stress", "Mental Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The current research will investigate the impact of general psychotherapy using common factors (i.e., techniques and communication skills that are common to all major forms of psychotherapy) to investigate whether mental health professionals can treat a variety of mental health concerns utilizing this general form of psychotherapy as opposed to specific forms of psychotherapy that may require specific trainings or education.", "detailedDescription"=>"The current research will investigate the impact of general psychotherapy using common factors (i.e., techniques and communication skills that are common to all major forms of psychotherapy) to investigate whether mental health professionals can treat a variety of mental health concerns utilizing this general form of psychotherapy as opposed to specific forms of psychotherapy that may require specific trainings or education."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* At least 18 years old\n* Experiencing self-reported psychological distress\n\nExclusion Criteria:\n\n* has engaged in self-harm within the last three months\n* has attempted suicide within the last year\n* has had an active plan to attempt suicide within the last 30 days\n* currently diagnosed with any eating disorder\n* has experienced hallucinations or delusions within the last 30 days\n* has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)"}, "identificationModule"=>{"nctId"=>"NCT06614842", "briefTitle"=>"Common Factors Group Psychotherapy for General Mental Health Concerns", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Alabama at Birmingham"}, "officialTitle"=>"Common Factors Group Psychotherapy for General Mental Health Concerns", "orgStudyIdInfo"=>{"id"=>"IRB-300013539"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Common Factors Group Therapy", "description"=>"We will use a general common factors psychotherapy utilizing only psychotherapeutic techniques common to most forms of psychotherapy (e.g., listening and communication skills)", "interventionNames"=>["Behavioral: Common Factors Group Psychotherapy"]}], "interventions"=>[{"name"=>"Common Factors Group Psychotherapy", "type"=>"BEHAVIORAL", "description"=>"This intervention will not contain active ingredients from established specific forms of psychotherapy (e.g., cognitive-behavioral therapy, dialectical behavioral therapy)", "armGroupLabels"=>["Common Factors Group Therapy"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Nicholas Borgogna, PhD", "role"=>"CONTACT", "email"=>"borgogna@uab.edu", "phone"=>"(205) 934-3850"}, {"name"=>"Drew Whittington, MS, MA", "role"=>"CONTACT", "email"=>"whitdrew@uab.edu"}], "overallOfficials"=>[{"name"=>"Nicholas Borgogna, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Alabama at Birmingham"}, {"name"=>"Drew Whittington, MS, MA", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Alabama at Birmingham"}]}, "ipdSharingStatementModule"=>{"timeFrame"=>"When results are published", "ipdSharing"=>"YES", "description"=>"All de-identified data collected will be available2", "accessCriteria"=>"Requesting researchers"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Alabama at Birmingham", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Nicholas C. Borgogna", "investigatorAffiliation"=>"University of Alabama at Birmingham"}}}}
