Transgender Therapeutic Support Groups

June 29, 2022 updated by: Rachel Narr, Denver Health and Hospital Authority

Mental and Physical Health Benefits of Pre- and Post-Surgical Transgender Therapeutic Support Groups

This study seeks to explore the effects for transgender people undergoing surgical interventions of participating in pre/post-surgical therapeutic support groups in order to assess the value of adding these programs to hospital systems that are offering gender-affirming surgeries. Participation in either therapeutic support group is expected to increase subjective well-being, increase perceived social support, and decrease clinically significant mental health symptoms compared to participants' baseline scores. It is expected that perceived social support will mediate the relation between group participation and improved subject well-being and mental health scores. In addition, participation in the post-surgical therapeutic support group is expected to reduce the average number of emergency department visits for participants in the group compared with transgender patients, post-gender-affirming surgery, in the hospital as a whole.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

At present, in the scientific literature, there are no known studies of the effectiveness of therapeutic support groups for supporting mental and physical health in transgender or gender nonconforming (TGNC)-identified individuals who are undergoing gender-affirming surgical interventions. Gender affirmation surgeries have been shown to decrease anxiety and depression, and increase well-being for TGNC individuals compared to the well-being of TGNC individuals who do not access surgery. In spite of this, surgery is inherently stressful for people undergoing it, and there are a plethora of medical and psychological complications that may be faced by people undergoing these surgeries.

Denver Health has greatly expanded gender-affirming interventions in the past three years due to the creation of the Center of Excellence; however, mental health services are still catching up. While support from other TGNC individuals has proven to be effective in general for reducing anxiety and depression, and community support groups have begun to be offered more regularly to support TGNC individuals, surgical support groups appear to largely not be offered. However, a high proportion of TGNC individuals express a desire for post-surgical support around surgery results (84.6% in a sample of 415 people), and over 90% of people are in favor of peer support around medical interventions more broadly. In other areas, specifically bariatric surgery, peer therapeutic support groups have been found to help with continued post-operative weight loss and mental health, likely due to the additional opportunities for support and connection with others undergoing similar things, group provision of ideas, and additional therapeutic support. While individual therapy is, and should continue to be, offered for this population, the addition of a group attended by individuals going through similar situations is likely to be helpful above and beyond individual therapy due to the provision of peer support, as well as the opportunity for participants to offer support to their peers. Seeing oneself as a help provider, rather than simply a help recipient (helper-therapy principle) has been demonstrated to have a powerful impact on the helper's own well-being across a host of medical and psychological situations.

Currently, therapeutic support groups are being developed to be offered to TGNC patients at Denver Health who are undergoing gender-affirming surgeries. Investigators will systematically collect data on well-being and mental health, as well as the mediating effect of feelings of cohesion on well-being, as well as the number of emergency department visits for participants in the groups as compared to the average number of emergency department visits across all TGNC patients in the Denver Health system for patients involved in these groups. Given the deficit of groups of this nature, as well as information on the helpfulness of therapeutic support groups for people undergoing gender-affirming surgeries, the investigators expect that this may be the first study on this topic. The study hypothesis is that participants in pre- and post-surgical support groups will experience increased well-being and mental health over a six month period, and that these increases will be mediated by group cohesion. Investigators also expect that attendance at these groups will lead to lower utilization of emergency services due to decreased anxiety and distress.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Transgender and gender non-conforming adults who take part in therapeutic support groups aimed at patients prior to and after gender-affirming surgical interventions.

Exclusion Criteria:

  • Age < 18
  • Substance abuse as primary presenting problem and unable to maintain sobriety for group
  • Severe mental illness with acute psychosis or paranoia
  • Patients with a very high need for crisis management
  • Patients with diagnosis of Antisocial Personality Disorder
  • Patients with severe cognitive impairments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pre- and Post-Surgical Transgender Therapeutic Support Groups
Behavioral: Pre- and Post-Surgical Transgender Therapeutic Support Group
Participants will be patients drawn from already-existing therapeutic support groups for transgender patients who are hoping to undergo or have undergone gender-affirming surgeries. Participants will be assured that there will be no changes to their care or decisions about their surgeries if they elect not to participate in the research portion of the groups, but would still like to attend groups as a non-research participant. Prior to their first group session, participants will be arrive early to go over consent again and allow participants to sign the consent form and fill out baseline measures of the outcomes of interest. Following this, research participants will participate in the groups as usual, and after each of their first 8 attended sessions, will be asked to fill out outcomes of interest again. Length of time for them to attend 8 sessions will be capped at 6 months, and participants will be asked to fill out measures again at six months following their enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well-Being
Time Frame: Up to 6 months
Subjective well-being will be assessed with the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). This is a 7-item scale assessing different aspects of mental well-being over the previous two weeks. It is scored on a 5-point Likert scale ranging from "None of the time" to "All of the time." The SWEMWBS has excellent internal consistency (Cronbach's α = .90), has shown both strong convergent and divergent validity, and has been validated in multiple populations and languages. In addition, this scale has been demonstrated to be sensitive to change over time in clinical populations receiving therapeutic intervention.
Up to 6 months
Broad mental health symptoms
Time Frame: Up to 6 months
Broad mental health symptoms will be measured with the Mental Health Inventory - 5, which is a 5-item measure of general mental health symptoms over the past month. Symptoms assessed include symptoms characteristic of depression and anxiety in particular. Cronbach's α for this scale = .84, and it demonstrates good construct and convergent validity. In addition, this measure has been demonstrated to be sensitive to levels of social support.
Up to 6 months
Perceived social support
Time Frame: Up to 6 months
Perceived social support will be evaluated using the 8-item Perceived Support subscale from the Berlin Social Support Scales. This subscale covers both emotional and instrumental support, focusing on how much support the respondents perceive themselves to be likely to receive, which has been shown to more strongly correlate with mood, adjustment, and wellness than objectively-measured received support. Each individual scale has been assessed in addition to the full measure, and the Perceived Support subscale has been found to have good internal consistency (Cronbach's α = .83. In addition, this measure has been shown to be sensitive to change in clinical populations.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency department visits
Time Frame: 6 months
Emergency department visits following surgery over a six-month period will be assessed using patient medical charts. Average number of visits by study participants will be compared to average number of visits by all transgender patients in our hospital system undergoing gender-affirming surgeries. Comparison emergency department visits will not be linked with and individuals or protected health information (PHI), and will be an average across all patients in this demographic group.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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