Clinical trial NCT03369054: Psychotherapy Trial With Transgender Clients
Official title: Determining the Feasibility and Effectiveness of Psychotherapy for Transgender Clients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transgender Persons, M01.777.500
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age of 18 or older
* Fluent in written and spoken English
* Willingness to participate in pre/post/session-by-session assessments and 12 ----Individual psychotherapy treatment sessions
* Individual identifies as transgender, trans, or non-binary (or somewhere along the gender minority spectrum).

Exclusion Criteria:

* Under 18 years old
* Reports current, unmanaged psychotic symptoms or symptoms requiring immediate inpatient treatment (e.g., hallucinations, delusions, threatening immediate suicidal behaviors)
* Currently engaging in psychotherapy
* Cannot attend therapy on Tuesdays from 2-7pm
* Individuals who lack the capacity to provide consent will be excluded.

Primary outcomes:
measure: Measuring Weekly Change in the Outcome Questionnaire 45; Lambert et al., 2013
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, 3 months, 9 months (within 6 months of study completion)
measure: Measuring 3 month and 9 month Change in the Outcome Questionnaire 45; Lambert et al., 2013
timeFrame: Prior to Week 1 (within 2 weeks of Week 1), 3 months, 9 months (within 6 months of study completion)
Secondary outcomes:
measure: Measuring 3 month and 9 month Change in the World Health Organization WHOQOL-BREF Quality of Life Assessment (WHOQOL-BREF); Power, 1998
timeFrame: Prior to Week 1 (within 2 weeks of Week 1), 3 months after starting Week 1, and 9 months after Week 1
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephanie Budge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Budge SL, Guo E, Mauk E, Tebbe EA. The development of an observational coding scheme to assess transgender and nonbinary clients' reported minority stress experiences. Psychotherapy (Chic). 2021 Jun;58(2):288-300. doi: 10.1037/pst0000368.
citation: Budge SL, Sinnard MT, Hoyt WT. Longitudinal effects of psychotherapy with transgender and nonbinary clients: A randomized controlled pilot trial. Psychotherapy (Chic). 2021 Mar;58(1):1-11. doi: 10.1037/pst0000310. Epub 2020 Jun 22.