Clinical trial NCT04217707: Transgender Therapeutic Support Groups
Official title: Mental and Physical Health Benefits of Pre- and Post-Surgical Transgender Therapeutic Support Groups
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gender Dysphoria in Adolescents and Adults
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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. Research participants will participate in the groups as usual, and after each of their first eight attended sessions, will be asked to fill out outcomes of interest again. Due to the possibility that participants may not attend eight group sessions, length of time for them to attend eight sessions will be capped at 6 months, and participants will be asked to fill out measures again at six months following their enrollment
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Well-Being
timeFrame: Up to 6 months
measure: Broad mental health symptoms
timeFrame: Up to 6 months
measure: Perceived social support
timeFrame: Up to 6 months
Secondary outcomes:
measure: Emergency department visits
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
References:
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