Transgender Therapeutic Support Groups

NCT04217707 | Withdrawn

• 1 other identifier: 20-0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Dysphoria in Adolescents and Adults

Outcome Measures

Primary Outcomes (3)

• Well-Being

  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

  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

  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 Outcomes (1)

• Emergency department visits

  6 months

Study Arms (1)

Pre- and Post-Surgical Transgender Therapeutic Support Groups

OTHER

Behavioral: Pre- and Post-Surgical Transgender Therapeutic Support Group

Interventions

Pre- and Post-Surgical Transgender Therapeutic Support Group BEHAVIORAL

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.

Pre- and Post-Surgical Transgender Therapeutic Support Groups

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender-identified individuals
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Related Publications (18)

• Branstrom R, Pachankis JE. Reduction in Mental Health Treatment Utilization Among Transgender Individuals After Gender-Affirming Surgeries: A Total Population Study. Am J Psychiatry. 2020 Aug 1;177(8):727-734. doi: 10.1176/appi.ajp.2019.19010080. Epub 2019 Oct 4.

  PMID: 31581798 BACKGROUND

• Pflum, S.R., Testa, R.J., Balsam, K.F., Goldblum, P.B., & Bongar, B. (2015). Social support, trans community connectedness, and mental health symptoms among transgender and gender nonconforming adults. Psychology of Sexual Orientation and Gender Identity, 2(3), 281-286.

  BACKGROUND

• Eyssel J, Koehler A, Dekker A, Sehner S, Nieder TO. Needs and concerns of transgender individuals regarding interdisciplinary transgender healthcare: A non-clinical online survey. PLoS One. 2017 Aug 28;12(8):e0183014. doi: 10.1371/journal.pone.0183014. eCollection 2017.

  PMID: 28846715 BACKGROUND

• Huberman, W.L. (2008). One psychologist's 7-year experience in working with surgical weight loss: The role of the mental health professional. Primary Psychiatry, 15(8), 42-47.

  BACKGROUND

• Livhits M, Mercado C, Yermilov I, Parikh JA, Dutson E, Mehran A, Ko CY, Shekelle PG, Gibbons MM. Is social support associated with greater weight loss after bariatric surgery?: a systematic review. Obes Rev. 2011 Feb;12(2):142-8. doi: 10.1111/j.1467-789X.2010.00720.x.

  PMID: 20158617 BACKGROUND

• Riessman, F. (1965). The "helper" therapy principle. Social Work, 10(2), 27-32.

  BACKGROUND

• Weinstein N, Ryan RM. When helping helps: autonomous motivation for prosocial behavior and its influence on well-being for the helper and recipient. J Pers Soc Psychol. 2010 Feb;98(2):222-44. doi: 10.1037/a0016984.

  PMID: 20085397 BACKGROUND

• Hutchinson DS, Anthony WA, Ashcraft L, Johnson E, Dunn EC, Lyass A, Rogers ES. The personal and vocational impact of training and employing people with psychiatric disabilities as providers. Psychiatr Rehabil J. 2006 Winter;29(3):205-13. doi: 10.2975/29.2006.205.213.

  PMID: 16450932 BACKGROUND

• Pagano ME, Post SG, Johnson SM. Alcoholics Anonymous-Related Helping and the Helper Therapy Principle. Alcohol Treat Q. 2010 Jan 1;29(1):23-34. doi: 10.1080/07347324.2011.538320. Epub 2011 Jan 19.

  PMID: 23525280 BACKGROUND

• Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.

  PMID: 19228398 BACKGROUND

• Ng Fat L, Scholes S, Boniface S, Mindell J, Stewart-Brown S. Evaluating and establishing national norms for mental wellbeing using the short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): findings from the Health Survey for England. Qual Life Res. 2017 May;26(5):1129-1144. doi: 10.1007/s11136-016-1454-8. Epub 2016 Nov 16.

  PMID: 27853963 BACKGROUND

• Shah N, Cader M, Andrews WP, Wijesekera D, Stewart-Brown SL. Responsiveness of the Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS): evaluation a clinical sample. Health Qual Life Outcomes. 2018 Dec 22;16(1):239. doi: 10.1186/s12955-018-1060-2.

  PMID: 30577856 BACKGROUND

• Vaingankar JA, Abdin E, Chong SA, Sambasivam R, Seow E, Jeyagurunathan A, Picco L, Stewart-Brown S, Subramaniam M. Psychometric properties of the short Warwick Edinburgh mental well-being scale (SWEMWBS) in service users with schizophrenia, depression and anxiety spectrum disorders. Health Qual Life Outcomes. 2017 Aug 1;15(1):153. doi: 10.1186/s12955-017-0728-3.

  PMID: 28764770 BACKGROUND

• Schwarzer, R. & Schulz, U. (2013). Berlin Social Support Scales (BSSS). Measurement Instrument Database for the Social Science. Retrieved from www.midss.ie

  BACKGROUND

• Norris FH, Kaniasty K. Received and perceived social support in times of stress: a test of the social support deterioration deterrence model. J Pers Soc Psychol. 1996 Sep;71(3):498-511. doi: 10.1037//0022-3514.71.3.498.

  PMID: 8831159 BACKGROUND

• Wethington E, Kessler RC. Perceived support, received support, and adjustment to stressful life events. J Health Soc Behav. 1986 Mar;27(1):78-89. No abstract available.

  PMID: 3711634 BACKGROUND

• McCabe CJ, Thomas KJ, Brazier JE, Coleman P. Measuring the mental health status of a population: a comparison of the GHQ-12 and the SF-36 (MHI-5). Br J Psychiatry. 1996 Oct;169(4):516-21. doi: 10.1192/bjp.169.4.516.

  PMID: 8894205 BACKGROUND

• Ware, J., Kosinki, M., & Gandek, B. (2000). SF-36 health survey: Manual & Interpretation Guide. Lincoln: Quality Metric Incorporated.

  BACKGROUND

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: 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

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)