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NCT03369054 · ClinicalTrials.gov registry record · NA
Psychotherapy Trial With Transgender Clients
A NA study of Transgender Persons, M01.777.500, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03369054: Completed NA study of Transgender Persons, M01.777.500, sponsored by University of Wisconsin, Madison.
NCT03369054 is a NA study of Transgender Persons, M01.777.500 that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03369054, a NA study of Transgender Persons, M01.777.500, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Measures overall mental health (symptom distress, interpersonal relations, social role). This is a 45-item likert scale. The total score ranges from 0 - 180 and includes a cutoff score of 63 or more (indicating symptoms of clinical distress). Higher scores suggest more symptoms of distress and difficulties in relationships. For symptom distress, scores range from 0-100 and the clinical cutoff score is 36 or more. For interpersonal relations, scores range from 0-44 and has a cutoff score of 15 or
Conditions Studied
Interventions
- BEHAVIORAL Minority Stress Treatment
- BEHAVIORAL Treatment As usual
Study Locations (1)
Wisconsin
- University of Wisconsin Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2019-01-10 |
| Phase | NA |
What the finished NCT03369054 record still lists
NCT03369054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Transgender Persons, M01.777.500 appearing as the primary indexed condition, and to 2 interventions - of which Minority Stress Treatment is the first listed.
NCT03369054 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03369054 about?
NCT03369054 is a clinical study titled "Psychotherapy Trial With Transgender Clients". 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,...
What is the current status of trial NCT03369054?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-12-01. Estimated completion is 2019-01-10.
What conditions does trial NCT03369054 study?
This clinical trial studies the following conditions: Transgender Persons, M01.777.500.
What interventions are being tested in trial NCT03369054?
The interventions under investigation include: Minority Stress Treatment (BEHAVIORAL), Treatment As usual (BEHAVIORAL).
Who is sponsoring clinical trial NCT03369054?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03369054 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03369054's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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