Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-01-31
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre- and Post-Surgical Transgender Therapeutic Support Groups
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Denver Health and Hospital Authority
OTHER
Responsible Party
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Rachel Narr
Postdoctoral Fellow
Locations
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Denver Health and Hospital Authority
Denver, Colorado, United States
Countries
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References
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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.
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.
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.
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.
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.
Riessman, F. (1965). The "helper" therapy principle. Social Work, 10(2), 27-32.
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.
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.
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.
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.
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.
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.
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.
Schwarzer, R. & Schulz, U. (2013). Berlin Social Support Scales (BSSS). Measurement Instrument Database for the Social Science. Retrieved from www.midss.ie
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.
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.
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.
Ware, J., Kosinki, M., & Gandek, B. (2000). SF-36 health survey: Manual & Interpretation Guide. Lincoln: Quality Metric Incorporated.
Other Identifiers
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20-0001
Identifier Type: -
Identifier Source: org_study_id
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