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).
COMPLETED
NA
25 participants
Measured at baseline and 5 months post-baseline
2025-09-16
Participant Flow
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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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-baselinePopulation: 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
| 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 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place