Gender Dysphoria in Adolescents and AdultsNCT04217707
Transgender Therapeutic Support Groups
A study testing Pre- and Post-Surgical Transgender Therapeutic Support Group in people with Gender Dysphoria in Adolescents and Adults, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria in Adolescents and Adults
- What is being tested?
- Pre- and Post-Surgical Transgender Therapeutic Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Transgender and gender non-conforming adults who take part in therapeutic support groups aimed at patients prior to and after gender-affirming surgical interventions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Official title: 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.
Read the 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.
- Being tested
- Pre- and Post-Surgical Transgender Therapeutic Support Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre- and Post-Surgical Transgender Therapeutic Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre- and Post-Surgical Transgender Therapeutic Support Groups | Other | Not described Receives: Behavioral: Pre- and Post-Surgical Transgender Therapeutic Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (1)
Emergency department visits
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study startJan 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study unable to be conducted due to COVID.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Gender Dysphoria in Adolescents and AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Narr, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217707
- Sponsor's protocol ID
- 20-0001
- Status last verified
- Jun 2022
- First submitted
- 2 Jan 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31581798Pflum, 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.
PubMed 28846715Huberman, 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.
PubMed 20158617Riessman, 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.
PubMed 20085397Hutchinson 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.
PubMed 16450932Pagano 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.
PubMed 23525280Stewart-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.
PubMed 19228398Ng 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.
PubMed 27853963Shah 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.
PubMed 30577856Vaingankar 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.
PubMed 28764770Schwarzer, 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.
PubMed 8831159
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental and Physical Health Benefits of Pre- and Post-Surgical Transgender Therapeutic Support Groups
- ClinicalTrials.gov ID
- NCT04217707
- Acronym / sponsor ID
- 20-0001
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study unable to be conducted due to COVID.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Pre- and Post-Surgical Transgender Therapeutic Support Groups | Other | Behavioral: Pre- and Post-Surgical Transgender Therapeutic Support Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Transgender and gender non-conforming adults who take part in therapeutic support groups aimed at patients prior to and after gender-affirming surgical interventions.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre- and Post-Surgical Transgender Therapeutic Support GroupParticipants 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. | Behavioural | Pre- and Post-Surgical Transgender Therapeutic Support Groups |
Primary outcome
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.
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.
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.
1 secondary outcome
Emergency department visits
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Background: PubMed 31581798Branstrom 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.
- BackgroundPflum, 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: PubMed 28846715Eyssel 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.
- BackgroundHuberman, 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: PubMed 20158617Livhits 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.
- BackgroundRiessman, F. (1965). The "helper" therapy principle. Social Work, 10(2), 27-32.
- Background: PubMed 20085397Weinstein 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.
- Background: PubMed 16450932Hutchinson 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.
- Background: PubMed 23525280Pagano 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.
- Background: PubMed 19228398Stewart-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.
- Background: PubMed 27853963Ng 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.
- Background: PubMed 30577856Shah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre- and Post-Surgical Transgender Therapeutic Support Group in people with Gender Dysphoria in Adolescents and Adults, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-Being (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217707, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.