Clinical trial NCT05140174: Psychotherapy Interventions to Support Transgender, Two-Spirit, and Nonbinary People of Color
Official title: Incorporating Radical Healing and Addressing Internalized Transnegativity in Psychotherapy for Transgender, Two-Spirit, and Nonbinary People of Color: An Open Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: mental health care
training
transgender
nonbinary
two spirit
access
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled psychotherapy trial (longitudinal study with no control group)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants who Find the Intervention Acceptable
timeFrame: up to 20 months
measure: Number of Participants Who Find Intervention Feasible
timeFrame: up to 20 months
measure: Number of Participants Who Indicate Barriers to Therapy Were Decreased
timeFrame: up to 20 months
Secondary outcomes:
measure: Change in Percent "Yes" on Yes/No subscales on Gender Minority Stress and Resilience Measure (GMSR)
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
measure: Change in Gender Minority Stress and Resilience Measure (GMSR) Scores
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
measure: Change in Outcome Questionnaire-45 (OQ-45) Score
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
measure: Change in Depression, Anxiety, and Stress Scale (DASS) Scores
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
measure: Change in Coping with Discrimination Scale (CDS) Score
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
measure: Change in Schwartz Outcome Scale Score
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
measure: Change in Client Task Specific Change Measure
timeFrame: baseline, post-intervention (up to 14 months), follow-up (up to 20 months)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephanie Budge
role: PRINCIPAL_INVESTIGATOR
References: