18 and older, any sex, with Transgender or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)Primary· Measured at baseline and 5 months post-baseline
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?") each 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). Item scores will be summed to obtain a total score ranging from 0 (min) to 20 (max), with a higher total score indicating greater depressive symptoms (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
9.68
± 4.96
5 months post-baseline
Group
Value
95% CI
TGE Individuals
4.82
± 5.04
Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)Secondary· Measured at baseline and 5 months post-baseline
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). Item scores will be summed to obtain a total score ranging from 0 (min) to 20 (max), with a higher total score indicating greater anxiety symptoms (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
10.1
± 3.72
5 months post-baseline
Group
Value
95% CI
TGE Individuals
5.05
± 4.69
Psychological Distress: Score on the Brief Symptom Inventory (BSI)Secondary· Measured at baseline and 5 months post-baseline
Psychological distress will be assessed using the Brief Symptom Inventory (BSI) consisting of 18 items scored from 0 (not at all) to 4 (extremely) regarding the extent to which 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") have distressed the respondent over the past week. Item scores will be averaged to obtain a total score ranging from 0 (min) to 4 (max), with a higher total score indicating greater psychological distress (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
1.46
± 0.729
5 months post-baseline
Group
Value
95% CI
TGE Individuals
1.11
± 0.745
Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS)Secondary· Measured at baseline and 5 months post-baseline
The Suicidal Ideation Attributes Scale (SIDAS) 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 (score of 0) 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 their total score will be recoded as 0. Total scores are calculated as the sum of the five items, with the controllability item reverse scored (i.e., original s
Baseline
Group
Value
95% CI
TGE Individuals
8.00
± 10.70
5 months post-baseline
Group
Value
95% CI
TGE Individuals
4.50
± 7.97
Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)Secondary· Measured at baseline and 5 months post-baseline
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). Item scores are summed to obtain a total score ranging from 0 (min) to 12 (max), where scores of 0 reflect no alcohol use. The higher the total score, the more likely it is that the respondent's drinking is affecting his/her health and safety (a worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
2.92
± 2.25
5 months post-baseline
Group
Value
95% CI
TGE Individuals
2.18
± 1.97
Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR)Secondary· Measured at baseline and 5 months post-baseline
Responses to each item on the 9-item Negative Expectations for Future Events subscale of the Gender Minority Stress and Resilience Measure (GMSR) are scored 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 to obtain a total score ranging from 0 (min) to 36 (max), with a higher total score indicating greater fear of future rejection based on gender identity (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
25.7
± 5.73
5 months post-baseline
Group
Value
95% CI
TGE Individuals
19.9
± 8.80
Internalized Stigma: Score on the Internalized Transphobia Subscale of the Gender Minority Stress and Resilience Measure (GMSR)Secondary· Measured at baseline and 5 months post-baseline
The eight items of the Internalized Transphobia subscale of the Gender Minority Stress and Resilience Measure (GMSR) are each scored on a five-point scale from 0 (strongly disagree) to 4 (strongly agree). An example item includes: "I resent my gender identity or expression." Item scores will be summed to produce a total score ranging from 0 (min) to 32 (max), where a higher total score indicates greater internalized transphobia (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
14.0
± 9.40
5 months post-baseline
Group
Value
95% CI
TGE Individuals
12.3
± 9.25
Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale (GRRS)Secondary· Measured at baseline and 5 months post-baseline
The 15-item Gender Identity Reflection and Rumination Scale (GRRS) assesses the extent to which respondents think about their gender identity in various ways. Responses to items are scored 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." Item scores are summed to obtain an overall score ranging from 15 to 60, where a higher total score indicates more rumination (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
38.1
± 10.1
5 months post-baseline
Group
Value
95% CI
TGE Individuals
34.5
± 7.59
Pride: Score on the Pride Subscale of the Gender Minority Stress and Resilience Measure (GMSR)Secondary· Measured at baseline and 5 months post-baseline
Responses to the eight items that make up the Pride subscale of the Gender Minority Stress and Resilience Measure (GMSR) are scored on a five-point scale from 0 (strongly disagree) to 4 (strongly agree). An example item is: "My gender identity or expression makes me feel special and unique." Item scores will be summed to produce an overall score ranging from 0 (min) to 32 (max), where a higher overall score indicate greater pride in one's gender identity (better outcome).
Baseline
Group
Value
95% CI
TGE Individuals
14.7
± 6.69
5 months post-baseline
Group
Value
95% CI
TGE Individuals
14.6
± 8.16
Community Connectedness: Score on the Community Connectedness Subscale of the Gender Minority Stress and Resilience Measure (GMSR)Secondary· Measured at baseline and 5 months post-baseline
Responses to items on the five-item Community Connectedness subscale of the Gender Minority Stress and Resilience Measure (GMSR) are scored on a five-point scale from 0 (strongly disagree) to 4 (strongly agree). An example item is: "I feel part of a community of people who share my gender identity." Item scores will be summed to produce a an overall score ranging from 0 (min) to 20 (max), where a higher overall score indicates greater connectedness with people who share one's gender identity (better outcome).
Baseline
Group
Value
95% CI
TGE Individuals
12.2
± 4.78
5 months post-baseline
Group
Value
95% CI
TGE Individuals
12.7
± 4.41
Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)Secondary· Measured at baseline and 5 months post-baseline
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." Item scores are averaged to produce an overall score ranging from 1 (min) to 5 (max), where a higher overall score indicates greater difficulties regulating emotions (worse outcome).
Baseline
Group
Value
95% CI
TGE Individuals
2.90
± 0.60
5 months post-baseline
Group
Value
95% CI
TGE Individuals
2.61
± 0.73
Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS)Secondary· Measured at baseline and 5 months post-baseline
The 12-item Multidimensional Scale of Perceived Social Support (MSPSS) assesses perceived support from family, friends, and significant others on an seven-point scale from 1 (very strongly disagree) to 7 (very strongly agree). An example item is: "There is a special person who is around when I am need." Item scores are averaged to obtain an overall score ranging from 1 (min) to 7 (max), where a higher overall score indicate greater social support (better outcome).
Baseline
Group
Value
95% CI
TGE Individuals
4.40
± 1.03
5 months post-baseline
Group
Value
95% CI
TGE Individuals
4.82
± 1.23
Adverse events — posted to ClinicalTrials.gov
Time frame: During an assessment or counseling session, from baseline survey to 5-months post-baseline.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06229132.