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Trial record 2 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Transgendered Persons"

Psychotherapy Trial With Transgender Clients

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ClinicalTrials.gov Identifier: NCT03369054
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):

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
Transgender Persons, M01.777.500 Behavioral: Minority Stress Treatment Behavioral: Treatment As usual

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369054


Contacts
Contact: Stephanie Budge, PhD 608-263-3753 budge@wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53706
Contact: Stephanie Budge, PhD    608-263-3753      
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Stephanie Budge, PhD University of Wisconsin, Madison
More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03369054     History of Changes
Other Study ID Numbers: 2017-0816
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
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