Nctid:
NCT06229132
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000059020", "term"=>"Suicidal Ideation"}], "ancestors"=>[{"id"=>"D000001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D000013405", "term"=>"Suicide"}, {"id"=>"D000016728", "term"=>"Self-Injurious Behavior"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "relevance"=>"LOW"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "relevance"=>"LOW"}, {"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M29364", "name"=>"Suicidal Ideation", "asFound"=>"Suicidality", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M16191", "name"=>"Suicide", "relevance"=>"LOW"}, {"id"=>"M19089", "name"=>"Self-Injurious Behavior", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>25}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-03-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-06-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)", "timeFrame"=>"5-month follow-up", "description"=>"Participants will complete the Overall Depression Severity \\& Impairment Scale (ODSIS) to assess past-week frequency, severity, and impairment related to depression symptoms. The ODSIS is comprised of five items (e.g., \"In the past week, how often have you felt depressed?\") measured on a five-point scale ranging from 0 (no depression in the past week) to 4 (constant depression: felt depressed all of the time). Scores range from 0 (min) to 20 (max), and scores will be calculated as a mean of the sum of item responses, with higher means indicating higher depressive symptoms (worse outcome)."}], "secondaryOutcomes"=>[{"measure"=>"Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)", "timeFrame"=>"5-month follow-up", "description"=>"Participants will complete the Overall Anxiety Severity \\& Impairment Scale (OASIS), which is comprised of five items (e.g., \"In the past week, how often have you felt anxious?\") measured on a five-point scale ranging from 0 (no anxiety in the past week) to 4 (constant anxiety: felt anxious all of the time and never really relaxed). Scores range from 0 (min) to 20 (max), and scores will be calculated as a mean of the sum of item responses, with higher means indicating higher anxiety symptoms (worse outcome)."}, {"measure"=>"Psychological distress: Score on the Brief Symptom Inventory", "timeFrame"=>"5-month follow-up", "description"=>"Psychological distress will be assessed using the 18-item Brief Symptom Inventory consisting of three six-item subscales ranging from 0 (not at all) to 4 (extremely) of severity of depression symptoms (e.g., \"feeling hopeless about the future\"), anxiety symptoms (e.g., \"feeling tense or keyed up\"), and somatization symptoms (e.g., \"feeling weak in parts of your body\"). Scores range from 0 (min) to 48 (max) and scores will be calculated as a mean of the sum of item responses, with higher means indicating higher psychological distress (worse outcome)."}, {"measure"=>"Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale", "timeFrame"=>"5-month follow-up", "description"=>"The Suicidal Ideation Attributes Scale will assess participants' past-month suicidal thoughts and severity on a ten-point scale ranging from 0 (never or not at all) to 10 (always or extremely). Participants who report no ideation in response to the first item (\"In the past month, how often have you had thoughts about suicide\") are not presented with subsequent four items regarding the severity of these thoughts and responses will be recoded to 0. Scores are calculated as the sum of the five items, with controllability reverse scored (10=0, 9=1, ..., 0=10). Total scores range from 0 (min) to 50 (max), with higher scores indicating higher suicidal ideation (worse outcome)."}, {"measure"=>"Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)", "timeFrame"=>"5-month follow-up", "description"=>"The three-item Alcohol Use Disorders Identification Test (AUDIT-C) will capture frequency of drinking over the past year (e.g., \"How often, during the past year did you have a drink containing alcohol?\"), with response options between 0 (never) and 4 (four or more times per week). Sums are scored, with a final score ranging from 0 (min) to12 (max), where scores of 0 reflect no alcohol use. The higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety."}, {"measure"=>"Anticipated Stigma: Score on the Negative Expectations for Future Events subscale of the Gender Minority Stress and Resilience Measure (GMSR)", "timeFrame"=>"5-month follow-up", "description"=>"The 9-item Negative Expectations for Future Events subscale of the Gender Minority Stress and Resilience Measure (GMSR) is measured on a five-point scale from 0 (strongly disagree) to 4 (strongly agree). An example item includes: \"If I express my gender history, employers would not hire me.\" The items will be summed and the total scores range from 0 (min) to 36 (max), with higher scores indicate fear of future rejection based on gender identity (worse outcome)."}, {"measure"=>"Internalized Stigma: Score on the Internalized Transphobia subscale of the GMSR", "timeFrame"=>"5-month follow-up", "description"=>"The eight-item Internalized Transphobia subscale of the GMSR is measured on a five-point scale from 0 (strongly disagree) to 4 (strongly agree). An example item includes: \"I resent my gender identity or expression.\" Items will be summed to produce a total score ranging from 0 (min) to 32 (max), in which higher scores indicated greater internalized transphobia (worse outcome)."}, {"measure"=>"Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale", "timeFrame"=>"5-month follow-up", "description"=>"The 15-item Gender Identity Reflection and Rumination Scale assesses the ways respondents think about their gender identity on a four-point scale from 1 (almost never) to 4 (almost always). An example item is: \"Analyze how my experience of my gender identity shapes who I am.\" Responses can range between 24 and 120. Items are summed and higher scores indicated more rumination (worse outcome)."}, {"measure"=>"Pride: Score on the Pride subscale of the GMSR", "timeFrame"=>"5-month follow-up", "description"=>"The eight-item Pride subscale of the GMSR is measured on a five-point scale from 1 (strongly disagree) to 5 (strongly agree). An example item is: \"My gender identity or expression makes me feel special and unique.\" The items will be summed to produce a score ranging from 1 (min) to 25 (max), in which higher scores indicate greater pride in participant's gender identity (better outcome)."}, {"measure"=>"Community Connectedness: Score on the Community Connectedness subscale of the GMSR", "timeFrame"=>"5-month follow-up", "description"=>"The five-item Community Connectedness subscale of the GMSR is measured on a five-point scale from 1 (strongly disagree) to 5 (strongly agree). An example item is: \"I feel part of a community of people who share my gender identity.\" Items will be summed to produce a final score ranging from 1 (min) to 25 (max), in which higher scores indicate greater connectedness with people who share their gender identity (better outcome)."}, {"measure"=>"Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)", "timeFrame"=>"5-month follow-up", "description"=>"The 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) assessed frequency of emotion dysregulation on a five-point scale from 1 (almost never) to 5 (almost always). An example item is: \"When I'm upset, I acknowledge my emotions.\" The items will be summed to produce a final score ranging from 37 (min) to 144 (max), in which and higher scores indicate greater difficulties regulating emotions (worse outcome)."}, {"measure"=>"Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS)", "timeFrame"=>"5-month follow-up", "description"=>"The 12-item Multidimensional Scale of Perceived Social Support (MSPSS) assesses perceived support from family, friends, and significant others, on an eight-point scale from 0 (very strongly disagree) to 7 (very strongly agree). An example item is: \"There is a special person who is around when I am need.\" A mean score will be calculated, ranging from 1 (min) to 7 (max), in which higher scores indicate higher social support (better outcome)."}, {"measure"=>"Unassertiveness: Score on the Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF)", "timeFrame"=>"5-month follow-up", "description"=>"The 19-item Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF) assesses respondents' assertive and unassertive behavior on a six-point scale from 1 (very uncharacteristic of me) to 6 (very characteristic of me). An example item is: \"I strive to get ahead as well as most people in my position.\" Items will be summed for a total score ranging from 47 (min) to 89 (max), where higher scores indicate higher unassertive behavior (worse outcome)."}, {"measure"=>"Rumination: Score on the Brooding subscale from the Ruminative Responses Scale (RRS)", "timeFrame"=>"5-month follow-up", "description"=>"The five-item Brooding subscale from the Ruminative Responses Scale (RRS) assesses the frequency with which participants experience brooding thoughts in response to depressed mood on a four-point scale from 1 (almost never) to 4 (almost always). An example item is: \"People think and do many different things when they feel depressed. Please indicate what you generally do. 'Think what am I doing to deserve this?'\" The items will be summed to produce a final score ranging from 22 (min) to 88 (max), in which higher scores indicating higher degrees of ruminative thoughts (worse outcome)."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Transgender", "Gender diverse", "Mental health"], "conditions"=>["Transgender", "Depression", "Anxiety", "Suicidality", "HIV"]}, "descriptionModule"=>{"briefSummary"=>"This study will evaluate an intervention's feasibility, acceptability and efficacy potential in a one-arm trial with Romanian transgender and gender diverse (e.g., gender non-binary) (TGD) individuals who report depression or anxiety. The intervention will consist of 16 1-hour sessions delivered by our trained therapists on Zoom. These sessions are based on 6 principles of LGBTQ-affirming CBT, as follows: (1) normalizing mood and anxiety as a common response to LGBTQ related stress; (2) challenging persistent, inflexible LGBQ-related stress-induced cognitions; (3) encouraging assertive behavior and open self-expression to effectively cope with the consequences of LGBTQ-related stress; (4) validating lesbian, gay, bisexual, and transgender (LGBTQ) clients' unique strengths; (5) building authentic relationships as an essential resource for LGBTQ people's mental health; and (6) recognizing intersectional identities as a source of stress and resilience.", "detailedDescription"=>"Transgender and gender diverse (e.g., gender non-binary) (TGD) individuals remain a hidden group in the Central Eastern European (CEE) country of Romania, with few protections, few equal rights, and many unmet needs. Emerging research with TGD persons in the region indicates that TGD Romanians report particularly high rates of HIV, depression, and hazardous alcohol use, primarily driven by the country's high structural stigma. Romania's healthcare system has little expertise for addressing these syndemic health threats. No targeted needs assessments or interventions exist to date in order to remedy these adversities and promote the wellbeing of TGD in Romania, or anywhere in CEE - the region with the fastest-growing HIV epidemic in the world. In response, the investigators propose to create and pilot-test the first intervention in CEE to address the sexual, mental, and behavioral health of TGD people. In Aim 1, the investigators will identify unique needs of TGD Romanians via interviews. Findings will be used in Aim 2 to modify an intervention manual to address gender minority stress and other TGD-specific determinants of mental health, hazardous alcohol use, and HIV risk. The intervention will be based on a Romanian-adapted EQuIP (Empowering Queer Identities in Psychotherapy) intervention d developed and successfully tested by our team in several global regions (e.g., the U.S., China). In Aim 3, the investigators will evaluate the adapted intervention's feasibility, acceptability, and efficacy potential in a one-arm trial with 25 TGD Romanians. By extending the intervention research to at-risk TGD populations, the investigators will ensure more equitable access to the interventions and embed them within a national infrastructure increasingly eager for and capable of reaching the full diversity of the Romanian LGBTQ population to address its currently unmet needs."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "genderDescription"=>"Individuals who report an identity as transgender or gender expansive (e.g., gender non-binary) and a gender that is different from their assigned sex at birth will be included.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. report an identity as transgender or gender expansive (e.g., gender non-binary) and a gender that is different from their assigned sex at birth;\n2. be ≥18 years old;\n3. report a score of ≥2.5 on either the two items measuring depression symptoms or the two items measuring anxiety symptoms using the Brief Symptom Inventory (BSI-4); and\n4. reside in Romania for the duration of the study (approximately 6 months).\n\nExclusion Criteria:\n\n1. active suicidality, mania, or psychosis and\n2. having received CBT in the prior 12 months."}, "identificationModule"=>{"nctId"=>"NCT06229132", "briefTitle"=>"Mental Health Support for Transgender and Gender-expansive Individuals", "organization"=>{"class"=>"OTHER", "fullName"=>"Columbia University"}, "officialTitle"=>"Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings", "orgStudyIdInfo"=>{"id"=>"AAAU2518-TGD"}, "secondaryIdInfos"=>[{"id"=>"R01MH116829", "link"=>"https://reporter.nih.gov/quickSearch/R01MH116829", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"LGBTQ-affirmative CBT treatment", "description"=>"LGBTQ-affirmative CBT includes client case conceptualizations to personalize treatment delivery and functional relevance. Modules raise awareness of the impact of sexual minority stress on mental, behavioral, and sexual health; instill cognitive flexibility toward minority stress cognitions; and reduce maladaptive avoidance tendencies rooted in minority stress. The treatment is guided by six principles: (1) normalizing mood and anxiety as a common response to LGBTQ-related stress; (2) challenging persistent, inflexible LGBTQ-related stress-induced cognitions; (3) encouraging assertive behavior and open self-expression in safe situations to effectively cope with the consequences of LGBTQ-related stress; (4) validating LGBTQ clients' unique strengths; (5) building authentic relationships as an essential resource for LGBTQ people's mental health; and (6) recognizing intersectional identities as a source of stress and resilience. The intervention consists of 16 sessions delivered on Zoom.", "interventionNames"=>["Behavioral: LGBTQ-affirmative CBT for transgender individuals"]}], "interventions"=>[{"name"=>"LGBTQ-affirmative CBT for transgender individuals", "type"=>"BEHAVIORAL", "description"=>"The intervention addresses unique stressors encountered by transgender individuals due to discrimination and lack of adequate and affirming healthcare resources.", "armGroupLabels"=>["LGBTQ-affirmative CBT treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia University School of Nursing", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Corina Lelutiu-Weinberger, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Columbia University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Columbia University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Yale University", "class"=>"OTHER"}, {"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor of Health Sciences Research", "investigatorFullName"=>"Corina Lelutiu-Weinberger", "investigatorAffiliation"=>"Columbia University"}}}}
