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Mental HealthNCT05140174

Psychotherapy Interventions to Support Transgender, Two-Spirit, and Nonbinary People of Color

A study testing Radical Healing and Internalized Stigma (RHIS) Training in people with Mental Health, run by University of Wisconsin, Madison 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

The proposed research will use a community-based participatory research (CBPR) approach to engage with community organizations to design and implement a project that trains therapists to provide effective, supportive, and engaged therapy to two-spirit, transgender, and nonbinary (2STNB) clients most impacted by… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
Radical Healing and Internalized Stigma (RHIS) Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
14 Jan 2022to 10 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • fluent in written and spoken English and/or Spanish
  • willingness to participate in pre/ post/ session-by session assessments and 15 individual psychotherapy treatment sessions
  • individual identifies as transgender, Two-Spirit, or nonbinary (or somewhere along the gender minority spectrum)
  • individual identifies as Black, Indigenous/Native, or otherwise as a person of color
  • not currently in individual therapy with another therapist

Who cannot join

  • reports current, unmanaged serious/persistent mental health symptoms requiring inpatient treatment (e.g., hallucinations, delusions)
  • individual does not identify as transgender, Two-Spirit, or nonbinary (or somewhere along the gender minority spectrum)
  • currently in therapy with an individual therapist

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Incorporating Radical Healing and Addressing Internalized Transnegativity in Psychotherapy for Transgender, Two-Spirit, and Nonbinary People of Color: An Open Clinical Trial

The proposed research will use a community-based participatory research (CBPR) approach to engage with community organizations to design and implement a project that trains therapists to provide effective, supportive, and engaged therapy to two-spirit, transgender, and nonbinary (2STNB) clients most impacted by barriers in accessing mental health care. 10 2STNB licensed mental health therapists will be identified and 50 2STNB of their clients will be enrolled and can expect to be on study for 10-20 months.

Read the detailed description

The long-term aim of this research is to ensure that therapists have access to training and engage in effective psychotherapy that ultimately reaches Two-spirit, transgender, and nonbinary (2STNB) clients who are the most impacted by unequal systems that create mental health concerns. To make real improvement in reaching TNB populations who lack the most access to mental health care, therapists must be properly trained and data from clients about their mental health experiences must be obtained. The proposed research will use a community-based participatory research (CBPR) approach to engage with community organizations to design and implement a project that trains therapists to provide effective, supportive, and engaged therapy to TNB clients most impacted by barriers in accessing mental health care.

Intervention:

  • Therapist Training: The Radical Healing and Internalized Stigma (RHIS) training provides education to therapists on radical healing and internalized stress. The ten therapists employed by the study will engage in an 8 hour intensive training by consultants hired to be on this study.
  • Participants:
  • T0 - baseline surveys
  • T1a to T1p - psychotherapy sessions (session complete within 11 months)
  • T2 - end intervention surveys
  • T3 - post intervention follow up (up to 6 months post intervention)

Aim 1: Determine best methods for recruiting 2STNB clients (e.g., increasing access to care), with attention to specific populations and barriers (BIPOC, lack of trust, finances, identity match, etc.)

Aim 2: Examine the feasibility/acceptability of a specialized training for therapists that focuses on healing and internalized stigma

Aim 3: Longitudinally investigate the impact of access to mental health care (e-therapy) on 2STNB people's well-being/mental health.

Endpoints:

The primary endpoint of the study is to determine if the study actually improved access to mental health care for study participants--this will be determined through qualitative interviewing. An additional endpoint is determining feasibility/acceptability of the study, which will also be assessed via qualitative methods.

A secondary endpoint for this study will be to determine if clients experienced psychological improvement in their mental health over the course of the study.

Conditions
Mental Health
Being tested
Radical Healing and Internalized Stigma (RHIS) Training
Keywords
mental health care, training, transgender, nonbinary, two spirit, access
Medical subject headings
Psychological Well-Being

What participants receive

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

  • Radical Healing and Internalized Stigma (RHIS) TrainingOther

    8-hour RHIS training includes, readings that discuss radical healing and internalized stigma, access to didactic information regarding radical healing and internalized stigma. Therapists will role play certain scenarios that may involve minority stress experiences and discuss with the trainers different types of responses that could be therapeutic. The training will focus on the most up to date research regarding transgender mental health, minority stress, radical healing, and role-plays that focus on these processes.

Study groups in NCT05140174
Study groupRoleWhat they receive
RHIS Informed PsychotherapyExperimentalTherapists will be trained in Radical Healing and Internalized Stigma (RHIS) and meet with their clients as part of their usual care for 15 tele-psychotherapy sessions
Receives: Other: Radical Healing and Internalized Stigma (RHIS) Training

What is being measured

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

  1. Number of Participants who Find the Intervention Acceptable

    Acceptability of the Intervention will be assessed qualitatively via semi-structured interviews post intervention.

    Measured: up to 20 months

  2. Number of Participants Who Find Intervention Feasible

    Feasibility of the Intervention will be assessed qualitatively via semi-structured interviews post intervention.

    Measured: up to 20 months

  3. Number of Participants Who Indicate Barriers to Therapy Were Decreased

    Participant Satisfaction with RHIS Intervention will be assessed qualitatively by semi-structured interview with researcher where access to mental health will be queried.

    Measured: up to 20 months

Secondary outcomes (7)

  1. Change in Percent "Yes" on Yes/No subscales on Gender Minority Stress and Resilience Measure (GMSR)

    Designed for use with transgender, nonbinary, and gender nonconforming people, the GMSR measure is one of the few that assesses gender identity-related constructs. It was designed to take into account unique gender minority stressors, such as internalized transphobia, and concealment of identity, and resilience factors including community connectedness and pride. The first 3 sub-scales for gender-related discrimination, gender-related rejection, and gender-related victimization are yes/no responses, where 'yes' responses indicated gender-related discrimination, rejection, and victimization.

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

  2. Change in Gender Minority Stress and Resilience Measure (GMSR) Scores

    Designed for use with transgender, nonbinary, and gender nonconforming people, the GMSR measure is one of the few that assesses gender identity-related constructs. It was designed to take into account unique gender minority stressors, such as internalized transphobia, and concealment of identity, and resilience factors including community connectedness and pride. The last sub-scales are given on a 5-point Likert response scale (Strongly Disagree = 0 to Strongly Agree = 4) and responses are summed. Higher scores are indicative of greater phenomena. Sub-scales are as follows:

    • Non-Affirmation: 6-items (0-24)
    • Internalized Transphobia: 8-items (0-32)
    • Pride: 8-items (0-32)
    • Negative Expectations for Future Events: 9-items (0-36)
    • Non-Disclosure: 5-items (0-20)
    • Community Connectedness: 5-items (0-20)

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

  3. Change in Outcome Questionnaire-45 (OQ-45) Score

    The OQ-45 is a measure of how a person has felt in the past week. Total possible range of scores from 0-180, where the higher the score, the more disturbed the participant.

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

  4. Change in Depression, Anxiety, and Stress Scale (DASS) Scores

    The DASS is a measure of how perceived depression, anxiety, and stress in the past week. Total possible range of scores for each domain is 0-21, where higher scores indicate more severe depression, anxiety, and stress.

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

  5. Change in Coping with Discrimination Scale (CDS) Score

    CDS is a 25-item scale measuring five specific strategies (i.e., education/advocacy, internalization, drug and alcohol use, resistance, and detachment) that minority individuals may use when coping with experiences of prejudice and discrimination. Items are responded to on a 6-point Likert-type scale ranging from 1 = never like me to 6 = always like me, for a range of 25 - 150. The investigators will analyze a longitudinal change through time, where better coping is evidenced by higher scores.

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

  6. Change in Schwartz Outcome Scale Score

    This is a 10-item measure of how someone feels over the previous 7 days. Total possible range of scores is 0-100 where higher scores indicate improved outcome.

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

  7. Change in Client Task Specific Change Measure

    This is a 16-item measure of how someone feels they've changed. Total possible range of scores is 16-112, where higher scores indicate improved outcome.

    Measured: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)

Timeline

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

  1. First posted1 Dec 2021
  2. Study start14 Jan 2022
  3. Primary completion10 Aug 2023
  4. Study completion10 Aug 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
Model description
Uncontrolled psychotherapy trial (longitudinal study with no control group)
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140174
Sponsor's protocol ID
2021-1133
Other IDs
A171600, Protocol Version 12/1/2021
Status last verified
Aug 2023
First submitted
17 Nov 2021
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Budge SL, Ben L, Lynn S, Tebbe EA. A Thematic Analysis of Teletherapy Benefits and Challenges for Two Spirit, Transgender, and Nonbinary People of Color: Qualitative Results from the HOPE Trial. Telemed J E Health. 2026 Mar;32(3):289-296. doi: 10.1177/15305627251399268. Epub 2026 Feb 3.

    PubMed 41313600

Questions about this trial

What is this clinical trial studying?

A study testing Radical Healing and Internalized Stigma (RHIS) Training in people with Mental Health, run by University of Wisconsin, Madison 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 5 inclusion and 3 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 31 Aug 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants who Find the Intervention Acceptable (time frame: up to 20 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140174, which also lists 1 linked publication.

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 31 Aug 2023.

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