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TransgenderNCT06229132

Mental Health Support for Transgender and Gender-expansive Individuals

A study testing LGBTQ-affirmative CBT for transgender individuals in people with Transgender and Depression, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transgender, Depression, Anxiety
What is being tested?
LGBTQ-affirmative CBT for transgender individuals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
15 Mar 2022to 30 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • be ≥18 years old;
  • 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
  • reside in Romania for the duration of the study (approximately 6 months).

Who cannot join

  • active suicidality, mania, or psychosis and
  • having received CBT in the prior 12 months.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University School of Nursing

    New York, New York, 10032

Other trials in United States

About this study

Official title: Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings

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.

Read the detailed description

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.

Being tested
LGBTQ-affirmative CBT for transgender individuals
Keywords
Transgender, Gender diverse, Mental health
Medical subject headings
Depression, Anxiety Disorders, Suicidal Ideation, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LGBTQ-affirmative CBT for transgender individualsBehavioural

    The intervention addresses unique stressors encountered by transgender individuals due to discrimination and lack of adequate and affirming healthcare resources.

Study groups in NCT06229132
Study groupRoleWhat they receive
LGBTQ-affirmative CBT treatmentOtherLGBTQ-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.
Receives: Behavioral: LGBTQ-affirmative CBT for transgender individuals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS)

    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).

    Measured: Measured at baseline and 5 months post-baseline

Secondary outcomes (13)
  1. Anxiety: Score on the Overall Anxiety Severity & Impairment Scale (OASIS)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  2. Psychological Distress: Score on the Brief Symptom Inventory (BSI)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  3. Suicidal Ideation: Score on the Suicidal Ideation Attributes Scale (SIDAS)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  4. Hazardous Drinking: Score on the Alcohol Use Disorders Identification Test (AUDIT-C)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  5. Anticipated Stigma: Score on the Negative Expectations for Future Events Subscale of the Gender Minority Stress and Resilience Measure (GMSR)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  6. Internalized Stigma: Score on the Internalized Transphobia Subscale of the Gender Minority Stress and Resilience Measure (GMSR)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  7. Gender Identity Rumination: Score on the Gender Identity Reflection and Rumination Scale (GRRS)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  8. Pride: Score on the Pride Subscale of the Gender Minority Stress and Resilience Measure (GMSR)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  9. Community Connectedness: Score on the Community Connectedness Subscale of the Gender Minority Stress and Resilience Measure (GMSR)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  10. Emotion Dysregulation: Score on the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  11. Social Support: Score on the Multidimensional Scale of Perceived Social Support (MSPSS)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  12. Unassertiveness: Score on the Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF)

    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).

    Measured: Measured at baseline and 5 months post-baseline

  13. Rumination: Score on the Brooding Subscale From the Ruminative Responses Scale (RRS)

    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).

    Measured: Measured at baseline and 5 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start15 Mar 2022
  3. Primary completion31 Dec 2022
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06229132
Sponsor's protocol ID
AAAU2518-TGD
Other IDs
R01MH116829
Status last verified
Aug 2025
First submitted
19 Jan 2024
Last updated
16 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing LGBTQ-affirmative CBT for transgender individuals in people with Transgender and Depression, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS) (time frame: Measured at baseline and 5 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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