Trial Outcomes & Findings for Mental Health Support for Transgender and Gender-expansive Individuals (NCT NCT06229132)

NCT ID: NCT06229132

Last Updated: 2025-09-16

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Measured at baseline and 5 months post-baseline

Results posted on

2025-09-16

Participant Flow

Participant milestones

Participant milestones
Measure
TGE Individuals
Transgender and gender expansive (TGE) individuals living in Romania
Overall Study
STARTED
25
Overall Study
COMPLETED
22
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mental Health Support for Transgender and Gender-expansive Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Age, Continuous
25.16 years
STANDARD_DEVIATION 6.39 • n=99 Participants
Sex/Gender, Customized
Female
13 Participants
n=99 Participants
Sex/Gender, Customized
Male
10 Participants
n=99 Participants
Sex/Gender, Customized
Intersex
2 Participants
n=99 Participants
Race/Ethnicity, Customized
Romanian
21 Participants
n=99 Participants
Race/Ethnicity, Customized
Roma
1 Participants
n=99 Participants
Race/Ethnicity, Customized
Other
3 Participants
n=99 Participants
Region of Enrollment
Romania
25 participants
n=99 Participants
Gender identity
Transgender woman
11 Participants
n=99 Participants
Gender identity
Transgender man
10 Participants
n=99 Participants
Gender identity
Nonbinary (e.g., genderqueer, agender, gender fluid)
4 Participants
n=99 Participants
Sexual orientation
Bisexual
5 Participants
n=99 Participants
Sexual orientation
Demisexual
1 Participants
n=99 Participants
Sexual orientation
Gay
1 Participants
n=99 Participants
Sexual orientation
Heterosexual
8 Participants
n=99 Participants
Sexual orientation
Pansexual
4 Participants
n=99 Participants
Sexual orientation
Queer
6 Participants
n=99 Participants
Educational attainment
High school or less
12 Participants
n=99 Participants
Educational attainment
Some college
4 Participants
n=99 Participants
Educational attainment
College degree
7 Participants
n=99 Participants
Educational attainment
Graduate degree
2 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)
Baseline
9.68 score on a scale
Standard Deviation 4.96
Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)
5 months post-baseline
4.82 score on a scale
Standard Deviation 5.04

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)
Baseline
10.1 score on a scale
Standard Deviation 3.72
Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)
5 months post-baseline
5.05 score on a scale
Standard Deviation 4.69

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Psychological Distress: Score on the Brief Symptom Inventory (BSI)
Baseline
1.46 score on a scale
Standard Deviation 0.729
Psychological Distress: Score on the Brief Symptom Inventory (BSI)
5 months post-baseline
1.11 score on a scale
Standard Deviation 0.745

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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 score of 10 reverse scored as 0, original score of 9 reverse scored as 1, …, original score of 0 reverse scored as 10). Total scores range from 0 (min) to 50 (max), with a higher total score indicating greater suicidal ideation (worse outcome).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS)
Baseline
8.00 score on a scale
Standard Deviation 10.70
Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS)
5 months post-baseline
4.50 score on a scale
Standard Deviation 7.97

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)
Baseline
2.92 score on a scale
Standard Deviation 2.25
Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)
5 months post-baseline
2.18 score on a scale
Standard Deviation 1.97

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
Baseline
25.7 score on a scale
Standard Deviation 5.73
Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
5 months post-baseline
19.9 score on a scale
Standard Deviation 8.80

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Internalized Stigma: Score on the Internalized Transphobia Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
Baseline
14.0 score on a scale
Standard Deviation 9.40
Internalized Stigma: Score on the Internalized Transphobia Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
5 months post-baseline
12.3 score on a scale
Standard Deviation 9.25

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale (GRRS)
Baseline
38.1 score on a scale
Standard Deviation 10.1
Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale (GRRS)
5 months post-baseline
34.5 score on a scale
Standard Deviation 7.59

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Pride: Score on the Pride Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
Baseline
14.7 score on a scale
Standard Deviation 6.69
Pride: Score on the Pride Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
5 months post-baseline
14.6 score on a scale
Standard Deviation 8.16

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Community Connectedness: Score on the Community Connectedness Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
Baseline
12.2 score on a scale
Standard Deviation 4.78
Community Connectedness: Score on the Community Connectedness Subscale of the Gender Minority Stress and Resilience Measure (GMSR)
5 months post-baseline
12.7 score on a scale
Standard Deviation 4.41

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
Baseline
2.90 score on a scale
Standard Deviation 0.60
Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
5 months post-baseline
2.61 score on a scale
Standard Deviation 0.73

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS)
Baseline
4.40 score on a scale
Standard Deviation 1.03
Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS)
5 months post-baseline
4.82 score on a scale
Standard Deviation 1.23

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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) with certain items reverse scored. An example item is: "I strive to get ahead as much as other people in my position." Item scores will be summed to obtain a total score from 19 (min) to 114 (max), where a higher total score indicates greater unassertive behavior (worse outcome).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Unassertiveness: Score on the Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF)
5 months post-baseline
67.3 score on a scale
Standard Deviation 9.45
Unassertiveness: Score on the Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF)
Baseline
72.0 score on a scale
Standard Deviation 11.1

SECONDARY outcome

Timeframe: Measured at baseline and 5 months post-baseline

Population: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.

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?'" Item scores will be summed to produce an overall score ranging from 5 (min) to 20 (max), where a higher overall score indicates a higher degree of ruminative thoughts (worse outcome).

Outcome measures

Outcome measures
Measure
TGE Individuals
n=25 Participants
Transgender and gender expansive (TGE) individuals living in Romania
Rumination: Score on the Brooding Subscale From the Ruminative Responses Scale (RRS)
Baseline
13.9 score on a scale
Standard Deviation 3.60
Rumination: Score on the Brooding Subscale From the Ruminative Responses Scale (RRS)
5 months post-baseline
12.4 score on a scale
Standard Deviation 3.24

Adverse Events

TGE Individuals

Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
TGE Individuals
n=25 participants at risk
Transgender and gender expansive (TGE) individuals living in Romania
Psychiatric disorders
Suicidal ideation
20.0%
5/25 • Number of events 7 • During an assessment or counseling session, from baseline survey to 5-months post-baseline

Other adverse events

Adverse event data not reported

Additional Information

Corina Lelutiu-Weinberger, PhD

Columbia University

Phone: (212) 342-1502

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place