Psychotherapy Trial With Transgender Clients

NCT03369054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-24

No results posted yet for this study

Summary

Transgender and gender diverse (TGD) individuals are at an increased risk for mental health concerns, including anxiety, trauma-based distress, depression, self-harm, and suicidality. Quantitative and qualitative studies have shown that support appears to mediate mental health concerns, but to date, there have been zero psychotherapy studies focusing on transgender and gender diverse patients. The NIH has noted that TGD patients are considered to be a "health disparities population," indicating that there is considerable research to support prevention and reduction in mental health disparities for this population.

There are two aims to the current study-Aim 1: investigate the feasibility of conducting a psychotherapy randomized controlled trial for transgender and gender diverse populations, and Aim 2: longitudinally investigate the impact of minority stress interventions on well-being for transgender and gender diverse patients.

First, it is hypothesized that this study will demonstrate feasibility regarding recruitment of transgender and gender diverse patients and that patients from both groups will report treatment acceptability. We also hypothesize that patients will report more acceptability for treatments that are focused on minority stress interventions. It is hypothesized that individuals in both the Minority Stress Treatment (MST) group and Treatment as Usual (TAU) group will both show improvements in well-being, but that the MST group will demonstrate larger effects in outcomes.

No known published studies have focused on minority stress psychotherapy interventions for transgender and gender diverse populations. The findings from the proposed study will provide a multitude of information regarding longitudinal psychotherapy interventions focusing on minority stress that will inform future treatment manuals and larger, multi-site studies.

Conditions

  • Transgender Persons, M01.777.500

Interventions

BEHAVIORAL

Minority Stress Treatment

The (MST) condition will include a psychoeducation session on minority stress for all participants during the initial assessment session prior to their first psychotherapy session. Prior to attending each of the 12 psychotherapy sessions during their electronic assessment (filling out the OQ-45 on Qualtrics on a computer provided by the study team), patients will be prompted to report up to three minority stress experiences over the previous week in the survey tool (which the therapists will not see). They will be prompted by their therapist to discuss these experiences within their psychotherapy sessions (for example, "Would you like to discuss any of the minority stress experiences you've had over the week?").

BEHAVIORAL

Treatment As usual

Treatment-as-usual (TAU) will occur as any usual 12-week treatment. The therapists will be encouraged to discuss any of the presenting concerns reported by patients and supervision will include usual care.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Stephanie Budge, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-01-10
Completion
2019-01-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369054 on ClinicalTrials.gov