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

NCT05140174 | Completed

• 3 other identifiers: 2021-1133A171600Protocol Version 12/1/2021
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mental Health

Keywords

mental health care; training; transgender; nonbinary; two spirit; access

Outcome Measures

Primary Outcomes (3)

• Number of Participants who Find the Intervention Acceptable

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

  up to 20 months

• Number of Participants Who Find Intervention Feasible

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

  up to 20 months

• 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.

  up to 20 months

Secondary Outcomes (7)

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

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

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

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

• Change in Outcome Questionnaire-45 (OQ-45) Score

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

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

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

• Change in Coping with Discrimination Scale (CDS) Score

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

Study Arms (1)

RHIS Informed Psychotherapy

EXPERIMENTAL

Therapists 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

Other: Radical Healing and Internalized Stigma (RHIS) Training

Interventions

Radical Healing and Internalized Stigma (RHIS) Training OTHER

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.

RHIS Informed Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants identify as transgender, Two-Spirit, or nonbinary (or somewhere along the gender minority spectrum) and identifies as Black, Indigenous/Native, or otherwise as a person of color.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• 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. 2025 Nov 21. doi: 10.1177/15305627251399268. Online ahead of print.

  PMID: 41313600 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Stephanie Budge

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uncontrolled psychotherapy trial (longitudinal study with no control group)

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: January 14, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)