Psychotherapy Trial With Transgender Clients

• ClinicalTrials.gov Identifier: NCT03369054
• Recruitment Status: Completed
• First Posted: December 11, 2017
• Last Update Posted: December 24, 2019
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Transgender Persons, M01.777.500	Behavioral: Minority Stress Treatment; Behavioral: Treatment As usual	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Determining the Feasibility and Effectiveness of Psychotherapy for Transgender Clients: A Randomized Controlled Trial
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: January 10, 2019
• Actual Study Completion Date: January 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Minority Stress; 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: 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?").
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Measuring Weekly Change in the Outcome Questionnaire 45; Lambert et al., 2013 [ Time Frame: 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) ]
   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 more. For social role, the range is 0-36 and includes a cutoff score of 12 or more. For all scales, higher scores indicate more distress. All scales are summed.
2. Measuring 3 month and 9 month Change in the Outcome Questionnaire 45; Lambert et al., 2013 [ Time Frame: Prior to Week 1 (within 2 weeks of Week 1), 3 months, 9 months (within 6 months of study completion) ]
   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 more. For social role, the range is 0-36 and includes a cutoff score of 12 or more. For all scales, higher scores indicate more distress. All scales are summed.

Secondary Outcome Measures :

1. Measuring 3 month and 9 month Change in the World Health Organization WHOQOL-BREF Quality of Life Assessment (WHOQOL-BREF); Power, 1998 [ Time Frame: Prior to Week 1 (within 2 weeks of Week 1), 3 months after starting Week 1, and 9 months after Week 1 ]
   This scale measures quality of life based on functioning (physical, psychological, social, and environment). The scale includes 26 questions on a likert scale. Scores range from 26-130 and are summed. Higher scores indicate higher quality of life.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: All participants must identify as transgender or gender non conforming
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin Madison

Madison, Wisconsin, United States, 53706

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Stephanie Budge, PhD; University of Wisconsin, Madison

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03369054
• Other Study ID Numbers: 2017-0816; A171600 ( Other Identifier: UW Madison ); EDUC\COUNSELING PSYCH ( Other Identifier: UW Madison )
• First Posted: December 11, 2017
• Last Update Posted: December 24, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No