Gender DysphoriaIERGDNCT05534763
Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems
A study testing IERGD and IER SUPPORT in people with Gender Dysphoria and Emotion Regulation, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This project aims to develop and evaluate if an internet delivered psychological intervention for transgender individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gender Dysphoria, Emotion Regulation, Internet Delivered Treatment
- What is being tested?
- IERGD and IER SUPPORT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 24 Aug 2022to 30 Jun 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having had an initial assessment at ANOVA for GD between March 2022 and November 2022 and found eligible for a diagnostic assessment period and having been put on a waitlist for continued evaluation.
- Being at least 18 years of age;
- Reporting elevated self-perceived psychiatric symptoms (e.g., depression, anxiety, suicidality) or functional impairment (difficulties maintaining school, work or daily routines);
- Be able to write and read in Swedish; and
- Have daily access to a computer with internet connection.
Who cannot join
- Evidence of active untreated mania, psychosis or other severe psychiatric symptoms that are deemed primary and need treatment;
- Current and increased suicide risk, such as intrusive suicide thoughts, or current suicide plans, or recent suicide attempt;
- Current enrollment in another psychological intervention study or currently receiving regular psychological treatment or
- Less than 6 weeks of stable psychopharmacotherapy if such treatment is ongoing.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
ANOVA, Karolinska University Hospital, Norra Stationsgatan 69, Plan 4
Stockholm, 17176
About this study
Official title: Internet-delivered Emotion Regulation Treatment (I-ER GD) for Transgender Adults and Co-occurring Mental Health Problems
This project aims to develop and evaluate if an internet delivered psychological intervention for transgender individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness.
In two studies, a psychological treatment for transgender adults (18+) seeking health care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated.
The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital
Read the detailed description
There are no psychosocial treatments for young transgender adults seeking treatment for gender dysphoria - psychological distress due to the incongruence between one's assigned sex and one's gender identity. This project aims to develop and evaluate if an internet delivered psychological intervention for individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness.
Data and Method: In three studies, a psychological treatment for transgender adults (18+) seeking care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated. Study 1 is a feasibility study (N=40) with pre-, post- and weekly assessments evaluating the intervention's feasibility, credibility, acceptability and preliminary efficacy. Study 2 is a qualitative interview study exploring participants' experience of the intervention.
Plan for project realization: The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital, with a large patient recruitment base and extensive experience of clinical studies providing good opportunities for later implementation in regular care.
Relevance: Studies show elevated rates of psychopathology in transgender adults. It has been suggested that experiences of minority stress, e.g., discrimination, internalized transphobia and gender identity concealment exhausts the ability to regulate negative emotions in an adaptive way. There is a need for treatment and preventive psychological interventions, particularly as the number of young transgender adults seeking gender affirming treatment has increased markedly during the 2000s. This project will lead to increased knowledge about the specific needs of this growing patient group and develop health care in accordance with national guidelines.
- Being tested
- IERGD, IER SUPPORT
- Medical subject headings
- Gender Dysphoria, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IERGDBehavioural
A 10 week behavioral treatment focusing on gender minority stress, maladaptive and adaptive emotion regulation, emotional awareness, the functionality of emotions, interpersonal skills and values and valued actions.
IER SUPPORTOther
A 5-week behavioral course for a designated support person (family, friend, other) to the person with GD. The course focuses on teachings on living with minority stress, maladaptive and adaptive emotion regulation, emotional awareness, validation, interpersonal skills and values.
| Study group | Role | What they receive |
|---|---|---|
| IERGD | Experimental | I-ER GD is a 10-week intervention directed to the person with GD, provided via the internet with therapist-support. During treatment, participants have an assigned psychologist to interact with and be offered support by, either through feedback on assignments, asynchronous chats or, if needed, by telephone. I-ER GD will focus on increasing adaptive emotion regulation skills, healthy identity development, interpersonal effectiveness skills, coping and building a resilient lifestyle through psychoeducation on gender minority stress, practicing adaptive emotion regulation skills, and reducing emotional and behavioral avoidance. Receives: Behavioral: IERGD |
| IER SUPPORT | Other | I-ER Support is a 5-week intervention directed to a support person, provided as an optional addition to I-ER GD. I-ER Support is administered in the same manner and in parallel to the I-ER GD intervention. Treatment content is based on the same principles as I-ER GD, but from the perspective of increasing emotional support and understanding of GD. The support person could benefit from increased coping and emotion regulation skills, as they may also be exposed to discrimination or stigma due to having a transgender child, sibling or loved one. In better understanding the processes of being stigmatized and with improved emotion regulation skills, the support person may offer better support and help alleviate burdening effects for the individual with GD. For this reason, I-ER support is primarily aimed at people without trans-experience. Receives: Other: IER SUPPORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited to I-ER GD.
Measures will include recruitment rate during study inclusion period (0-30 participants).
Measured: At pretreatment.
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD
Measures treatment satisfaction after treatment. Range 8-32, higher values equals higher satisfaction with treatment.
Measured: At post-treatment (week 12).
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
Measured: At treatment week 2.
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.
Measures negative effects of psychological treatment after an intervention. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.
Measured: At post-treatment (week 12).
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
Measured: At mid-treatment (week 5).
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
Measured: At post-treatment (week 12).
Number of participants recruited to I-ER SUPPORT.
Measures will include recruitment rate during study inclusion period (0-15 participants).
Measured: At pretreatment.
The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT
Measures treatment satisfaction. Range 8-32, higher values equals higher satisfaction with treatment.
Measured: At post-treatment (week 10).
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER SUPPORT
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
Measured: At treatment week 2.
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER SUPPORT.
Measures negative effects of psychological treatment. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.
Measured: At post-treatment (week 10).
Secondary outcomes (25)
Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.
Changes in the Gender minority stress and resilience scale. Range 0-17 for sub scales Gender related discrimination, rejection, victimization. Higher values represents higher levels of discrimination, rejection, victimization etc. Range 0-164 for sub scales Non-affirmation of gender identity, Internalized transphobia, Pride, Negative expectations for the future, Nondisclosure and Community connectedness. Higher values represents higher levels of whatever the sub scale covers (e.g. pride, internalized transphobia, community connectedness etc).
Measured: At pre-treatment and at post treatment (week 12)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Measured: At pre-treatment and at post treatment (week 12)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Measured: Weekly during the treatment (weeks 1-11)
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.
Changes in the Emotion Regulation Questionnaire, ERQ. Subscales Cognitive reappraisal (Range 6-42). and Suppression (Range 4-28). Higher values equals better outcomes in reappraisal, and worse outcomes in Suppression.
Measured: At pre-treatment and at post treatment (week 12)
Changes inThe Alcohol Use Disorders Identification Test (AUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
Changes in alcohol consumption. Range 0-40 where higher values equal higher substance use, worse outcomes.
Measured: At baseline and at post treatment (week 12)
Changes inThe Drug Use Disorders Identification Test (DUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
Changes in drug consumption. Range 0-44 where higher values equal higher substance use, worse outcomes.
Measured: At baseline and at post treatment (week 12)
Changes in Gender Congruence and Life Satisfaction Scale (GCLS; Dhejne et al. 2019) for I-ER GD
Change and measure improvements in gender (in)congruence, related mental well-being, and life satisfaction throughout the process of undergoing gender affirming medical interventions. Range: 38-190 where higher values indicate greater gender congruence, greater gender-related well-being, and greater life satisfaction.
Measured: At baseline and at post treatment (week 12)
Changes in Work and social adjustment scale (WSAS; Marks 1986) for I-ER GD
Changes in functioning. Ranges from 0-40 where higher scores indicate a more impaired functioning.
Measured: At baseline and at post treatment (week 12)
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Changes in anxiety over 20 different situations. Ranges from 0-80 where higher scores indicate a higher social anxiety.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Changes in anxiety over 20 different situations. Ranges from 0-80 where higher scores indicate a higher social anxiety.
Measured: Weekly during the treatment (weeks 1-11)
Changes in Montgomery Åsberg Depression Rating Scale (MADRS-S; Montgomery & Åsberg 1979) for I-ER GD
Changes in depressive symptoms. Ranges from 0-54 where higher scores indicate higher depressive severity.
Measured: At pre-treatment and post treatment (week 12)
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Changes in instances and forms of self-harming behavior. Higher number of instances indicates worse outcomes.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Changes in instances and forms of self-harming behavior. Higher number of instances indicates worse outcomes.
Measured: Weekly during the treatment (weeks 1-11)
Changes in Brunnsviken Brief Quality of Life Inventory (BBQ; Lindner et al, 2016) for I-ER GD
Changes in perceived quality of life. Range: 0-96. Higher scores indicate a higher perceived quality of life.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Satisfaction With Life, Swedish (SWLS; Diener 1985) for I-ER GD
Changes in global cognitive judgements of one's life. Range: 0-35. Higher score indicates higher satisfaction with one's life.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Perceived Stress Scale (PSS-14; Cohen, Kamarck & Mermelstein 1983) for I-ER GD
Changes in perceived stress. Range: 0-56. Higher scores indicate greater perceived stress.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al, 1988) for I-ER GD
Changes in perceived support from family, friends and significant other(s). Range: 12-84. Higher scores indicate greater perceived stress.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Rosenberg's scale of self-esteem (Rosenberg; Schmitt & Allik 2005) for I-ER GD
Changes in self-esteem. Range: 0-40. Higher scores indicate higher self-esteem.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Rumination Response Scale (RRS-10; Nolen-Hoeksema, Morrow 1991) for I-ER GD
Changes in ruminative tendencies. Range: 10-40. Higher scores indicate higher levels of ruminative response styles.
Measured: At pre-treatment and at post treatment (week 12)
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER GD
Changes in one's ability to recognize emotions. Range 12-60. Higher scores indicates higher ability to recognize and label emotions.
Measured: At pre-treatment and at post treatment (week 12)
Changes in The Gender/Sex diversity belief scale (GSDB; Schudson & van Anders, 2022) for I-ER SUPPORT
Changes in the Gender/Sex diversity belief scale. Range 23-161. Higher values equals more positive attitudes toward transgender individuals.
Measured: At pre-treatment and at post treatment (week 10)
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER SUPPORT
Changes in one's ability to recognize emotions. Range 12-60. Higher scores indicates higher ability to recognize and label emotions.
Measured: At pre-treatment and at post treatment (week 10)
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER SUPPORT.
Changes in the Emotion Regulation Questionnaire, ERQ. Subscales Cognitive reappraisal (Range 6-42). and Suppression (Range 4-28). Higher values equals better outcomes in reappraisal, and worse outcomes in Suppression.
Measured: At pre-treatment and at post treatment (week 10)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Measured: At pre-treatment and at post treatment (week 10)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Measured: Weekly during the treatment (weeks 1-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start24 Aug 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study 1 is a feasibility study with pre- and post-assessments evaluating feasibility, acceptability and satisfaction of the study protocol and the preliminary efficacy of I-ER. Study 1 consists of IERGD (a behavioral intervention for individuals with GD) and IER SUPPORT (a parallell behavioral course for a support person to the person with GD).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Sahlin, Karolinska Institutet
- Investigators
- Hanna Sahlin, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534763
- Sponsor's protocol ID
- 2022-00577-01
- Acronym
- IERGD
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Emotion Regulation Treatment (I-ER GD) for Transgender Adults and Co-occurring Mental Health Problems
- ClinicalTrials.gov ID
- NCT05534763
- Acronym / sponsor ID
- IERGD / 2022-00577-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Sep 2022 (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 project aims to develop and evaluate if an internet delivered psychological intervention for transgender individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness.
In two studies, a psychological treatment for transgender adults (18+) seeking health care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated.
The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital
Detailed description
There are no psychosocial treatments for young transgender adults seeking treatment for gender dysphoria - psychological distress due to the incongruence between one's assigned sex and one's gender identity. This project aims to develop and evaluate if an internet delivered psychological intervention for individuals undergoing assessment for gender dysphoria and a support person, is feasible, acceptable and effective in increasing emotional skills, strengthening a healthy identity development, social support and resilience to current and future mental illness.
Data and Method: In three studies, a psychological treatment for transgender adults (18+) seeking care for gender dysphoria and a support person (i.e., relative, friend) will be evaluated. Study 1 is a feasibility study (N=40) with pre-, post- and weekly assessments evaluating the intervention's feasibility, credibility, acceptability and preliminary efficacy. Study 2 is a qualitative interview study exploring participants' experience of the intervention.
Plan for project realization: The project will be carried out at a specialized unit for transgender health care (ANOVA) at Karolinska University Hospital, with a large patient recruitment base and extensive experience of clinical studies providing good opportunities for later implementation in regular care.
Relevance: Studies show elevated rates of psychopathology in transgender adults. It has been suggested that experiences of minority stress, e.g., discrimination, internalized transphobia and gender identity concealment exhausts the ability to regulate negative emotions in an adaptive way. There is a need for treatment and preventive psychological interventions, particularly as the number of young transgender adults seeking gender affirming treatment has increased markedly during the 2000s. This project will lead to increased knowledge about the specific needs of this growing patient group and develop health care in accordance with national guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study 1 is a feasibility study with pre- and post-assessments evaluating feasibility, acceptability and satisfaction of the study protocol and the preliminary efficacy of I-ER. Study 1 consists of IERGD (a behavioral intervention for individuals with GD) and IER SUPPORT (a parallell behavioral course for a support person to the person with GD).
| Arm | Type | Receives |
|---|---|---|
| IERGD | Experimental | Behavioral: IERGDI-ER GD is a 10-week intervention directed to the person with GD, provided via the internet with therapist-support. During treatment, participants have an assigned psychologist to interact with and be offered support by, either through feedback on assignments, asynchronous chats or, if needed, by telephone. I-ER GD will focus on increasing adaptive emotion regulation skills, healthy identity development, interpersonal effectiveness skills, coping and building a resilient lifestyle through psychoeducation on gender minority stress, practicing adaptive emotion regulation skills, and reducing emotional and behavioral avoidance. |
| IER SUPPORT | Other | Other: IER SUPPORTI-ER Support is a 5-week intervention directed to a support person, provided as an optional addition to I-ER GD. I-ER Support is administered in the same manner and in parallel to the I-ER GD intervention. Treatment content is based on the same principles as I-ER GD, but from the perspective of increasing emotional support and understanding of GD. The support person could benefit from increased coping and emotion regulation skills, as they may also be exposed to discrimination or stigma due to having a transgender child, sibling or loved one. In better understanding the processes of being stigmatized and with improved emotion regulation skills, the support person may offer better support and help alleviate burdening effects for the individual with GD. For this reason, I-ER support is primarily aimed at people without trans-experience. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients having had an initial assessment at ANOVA for GD between March 2022 and November 2022 and found eligible for a diagnostic assessment period and having been put on a waitlist for continued evaluation.
- Being at least 18 years of age;
- Reporting elevated self-perceived psychiatric symptoms (e.g., depression, anxiety, suicidality) or functional impairment (difficulties maintaining school, work or daily routines);
- Be able to write and read in Swedish; and
- Have daily access to a computer with internet connection.
Key exclusion criteria (4 listed)
- Evidence of active untreated mania, psychosis or other severe psychiatric symptoms that are deemed primary and need treatment;
- Current and increased suicide risk, such as intrusive suicide thoughts, or current suicide plans, or recent suicide attempt;
- Current enrollment in another psychological intervention study or currently receiving regular psychological treatment or
- Less than 6 weeks of stable psychopharmacotherapy if such treatment is ongoing.
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 |
|---|---|---|
| IERGDA 10 week behavioral treatment focusing on gender minority stress, maladaptive and adaptive emotion regulation, emotional awareness, the functionality of emotions, interpersonal skills and values and valued actions. | Behavioural | IERGD |
| IER SUPPORTA 5-week behavioral course for a designated support person (family, friend, other) to the person with GD. The course focuses on teachings on living with minority stress, maladaptive and adaptive emotion regulation, emotional awareness, validation, interpersonal skills and values. | Other | IER SUPPORT |
Primary outcome
Number of participants recruited to I-ER GD.
Time frame: At pretreatment.
Measures will include recruitment rate during study inclusion period (0-30 participants).
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD
Time frame: At post-treatment (week 12).
Measures treatment satisfaction after treatment. Range 8-32, higher values equals higher satisfaction with treatment.
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.
Time frame: At treatment week 2.
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.
Time frame: At post-treatment (week 12).
Measures negative effects of psychological treatment after an intervention. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
Time frame: At mid-treatment (week 5).
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
Time frame: At post-treatment (week 12).
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
Number of participants recruited to I-ER SUPPORT.
Time frame: At pretreatment.
Measures will include recruitment rate during study inclusion period (0-15 participants).
The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT
Time frame: At post-treatment (week 10).
Measures treatment satisfaction. Range 8-32, higher values equals higher satisfaction with treatment.
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER SUPPORT
Time frame: At treatment week 2.
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER SUPPORT.
Time frame: At post-treatment (week 10).
Measures negative effects of psychological treatment. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.
25 secondary outcomes
Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
Time frame: At pre-treatment and at post treatment (week 12)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
Time frame: Weekly during the treatment (weeks 1-11)
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.
Time frame: At pre-treatment and at post treatment (week 12)
Changes inThe Alcohol Use Disorders Identification Test (AUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
Time frame: At baseline and at post treatment (week 12)
Changes inThe Drug Use Disorders Identification Test (DUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
Time frame: At baseline and at post treatment (week 12)
Changes in Gender Congruence and Life Satisfaction Scale (GCLS; Dhejne et al. 2019) for I-ER GD
Time frame: At baseline and at post treatment (week 12)
Changes in Work and social adjustment scale (WSAS; Marks 1986) for I-ER GD
Time frame: At baseline and at post treatment (week 12)
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Time frame: Weekly during the treatment (weeks 1-11)
Changes in Montgomery Åsberg Depression Rating Scale (MADRS-S; Montgomery & Åsberg 1979) for I-ER GD
Time frame: At pre-treatment and post treatment (week 12)
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Time frame: Weekly during the treatment (weeks 1-11)
Changes in Brunnsviken Brief Quality of Life Inventory (BBQ; Lindner et al, 2016) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Satisfaction With Life, Swedish (SWLS; Diener 1985) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Perceived Stress Scale (PSS-14; Cohen, Kamarck & Mermelstein 1983) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al, 1988) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Rosenberg's scale of self-esteem (Rosenberg; Schmitt & Allik 2005) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Rumination Response Scale (RRS-10; Nolen-Hoeksema, Morrow 1991) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER GD
Time frame: At pre-treatment and at post treatment (week 12)
Changes in The Gender/Sex diversity belief scale (GSDB; Schudson & van Anders, 2022) for I-ER SUPPORT
Time frame: At pre-treatment and at post treatment (week 10)
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER SUPPORT
Time frame: At pre-treatment and at post treatment (week 10)
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER SUPPORT.
Time frame: At pre-treatment and at post treatment (week 10)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Time frame: At pre-treatment and at post treatment (week 10)
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Time frame: Weekly during the treatment (weeks 1-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
Related trials for Gender Dysphoria
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Comparative Study of Gender Identity Disorder Versus Control
Gender Dysphoria, Adult
RecruitingObservational study
China Gender-affirming Hormone Therapy Study
Transgender, Gender Incongruence
RecruitingObservational study
GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes
Gender Dysphoria, Adult
RecruitingObservational study
Puberty, Testosterone, and Brain Development
Gender Identity, Gender Dysphoria in Adolescents and Adults
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.
Hanna Sahlin, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IERGD and IER SUPPORT in people with Gender Dysphoria and Emotion Regulation, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Sep 2023. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants recruited to I-ER GD. (time frame: At pretreatment.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2023.