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Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems (IERGD)

Primary Purpose

Gender Dysphoria, Emotion Regulation, Internet Delivered Treatment

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
IERGD
IER SUPPORT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gender Dysphoria

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients having had an initial assessment at ANOVA for GD between January 2022 and September 2022 and found eligible for a diagnostic assessment period and having been put on a waitlist for continued evaluation.
  2. Being at least 18 years of age;
  3. Reporting elevated self-perceived psychiatric symptoms (e.g., depression, anxiety, suicidality) or functional impairment (difficulties maintaining school, work or daily routines);
  4. Be able to write and read in Swedish; and
  5. Have daily access to a computer with internet connection.

Exclusion Criteria:

  1. Evidence of active untreated mania, psychosis or other severe psychiatric symptoms that are deemed primary and need treatment;
  2. Current and increased suicide risk, such as intrusive suicide thoughts, or current suicide plans, or recent suicide attempt;
  3. Current enrollment in another psychological intervention study or currently receiving regular psychological treatment or
  4. Less than 6 weeks of stable psychopharmacotherapy if such treatment is ongoing.

Sites / Locations

  • ANOVA, Karolinska University Hospital, Norra Stationsgatan 69, Plan 4

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IERGD

IER SUPPORT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants recruited to I-ER GD.
Measures will include recruitment rate during study inclusion period (0-30 participants).
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.
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.
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.
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.
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.
Number of participants recruited to I-ER SUPPORT.
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
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
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.
Measures negative effects of psychological treatment. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 30, 2022
Last Updated
September 8, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05534763
Brief Title
Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems
Acronym
IERGD
Official Title
Internet-delivered Emotion Regulation Treatment (I-ER GD) for Transgender Adults and Co-occurring Mental Health Problems
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria, Emotion Regulation, Internet Delivered Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IERGD
Arm Type
Experimental
Arm Description
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.
Arm Title
IER SUPPORT
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IERGD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
IER SUPPORT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants recruited to I-ER GD.
Description
Measures will include recruitment rate during study inclusion period (0-30 participants).
Time Frame
At pretreatment.
Title
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD
Description
Measures treatment satisfaction after treatment. Range 8-32, higher values equals higher satisfaction with treatment.
Time Frame
At post-treatment (week 12).
Title
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.
Description
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
Time Frame
At treatment week 2.
Title
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.
Description
Measures negative effects of psychological treatment after an intervention. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.
Time Frame
At post-treatment (week 12).
Title
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
Description
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
Time Frame
At mid-treatment (week 5).
Title
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
Description
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
Time Frame
At post-treatment (week 12).
Title
Number of participants recruited to I-ER SUPPORT.
Description
Measures will include recruitment rate during study inclusion period (0-15 participants).
Time Frame
At pretreatment.
Title
The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT
Description
Measures treatment satisfaction. Range 8-32, higher values equals higher satisfaction with treatment.
Time Frame
At post-treatment (week 10).
Title
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER SUPPORT
Description
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
Time Frame
At treatment week 2.
Title
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER SUPPORT.
Description
Measures negative effects of psychological treatment. Range 0-20, higher values equals worse outcomes, and more negative effects of treatment.
Time Frame
At post-treatment (week 10).
Secondary Outcome Measure Information:
Title
Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.
Description
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).
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
Description
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.
Description
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time Frame
Weekly during the treatment (weeks 1-11)
Title
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.
Description
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.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes inThe Alcohol Use Disorders Identification Test (AUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
Description
Changes in alcohol consumption. Range 0-40 where higher values equal higher substance use, worse outcomes.
Time Frame
At baseline and at post treatment (week 12)
Title
Changes inThe Drug Use Disorders Identification Test (DUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.
Description
Changes in drug consumption. Range 0-44 where higher values equal higher substance use, worse outcomes.
Time Frame
At baseline and at post treatment (week 12)
Title
Changes in Gender Congruence and Life Satisfaction Scale (GCLS; Dhejne et al. 2019) for I-ER GD
Description
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.
Time Frame
At baseline and at post treatment (week 12)
Title
Changes in Work and social adjustment scale (WSAS; Marks 1986) for I-ER GD
Description
Changes in functioning. Ranges from 0-40 where higher scores indicate a more impaired functioning.
Time Frame
At baseline and at post treatment (week 12)
Title
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Description
Changes in anxiety over 20 different situations. Ranges from 0-80 where higher scores indicate a higher social anxiety.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD
Description
Changes in anxiety over 20 different situations. Ranges from 0-80 where higher scores indicate a higher social anxiety.
Time Frame
Weekly during the treatment (weeks 1-11)
Title
Changes in Montgomery Åsberg Depression Rating Scale (MADRS-S; Montgomery & Åsberg 1979) for I-ER GD
Description
Changes in depressive symptoms. Ranges from 0-54 where higher scores indicate higher depressive severity.
Time Frame
At pre-treatment and post treatment (week 12)
Title
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Description
Changes in instances and forms of self-harming behavior. Higher number of instances indicates worse outcomes.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD
Description
Changes in instances and forms of self-harming behavior. Higher number of instances indicates worse outcomes.
Time Frame
Weekly during the treatment (weeks 1-11)
Title
Changes in Brunnsviken Brief Quality of Life Inventory (BBQ; Lindner et al, 2016) for I-ER GD
Description
Changes in perceived quality of life. Range: 0-96. Higher scores indicate a higher perceived quality of life.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Satisfaction With Life, Swedish (SWLS; Diener 1985) for I-ER GD
Description
Changes in global cognitive judgements of one's life. Range: 0-35. Higher score indicates higher satisfaction with one's life.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Perceived Stress Scale (PSS-14; Cohen, Kamarck & Mermelstein 1983) for I-ER GD
Description
Changes in perceived stress. Range: 0-56. Higher scores indicate greater perceived stress.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al, 1988) for I-ER GD
Description
Changes in perceived support from family, friends and significant other(s). Range: 12-84. Higher scores indicate greater perceived stress.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Rosenberg's scale of self-esteem (Rosenberg; Schmitt & Allik 2005) for I-ER GD
Description
Changes in self-esteem. Range: 0-40. Higher scores indicate higher self-esteem.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Rumination Response Scale (RRS-10; Nolen-Hoeksema, Morrow 1991) for I-ER GD
Description
Changes in ruminative tendencies. Range: 10-40. Higher scores indicate higher levels of ruminative response styles.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER GD
Description
Changes in one's ability to recognize emotions. Range 12-60. Higher scores indicates higher ability to recognize and label emotions.
Time Frame
At pre-treatment and at post treatment (week 12)
Title
Changes in The Gender/Sex diversity belief scale (GSDB; Schudson & van Anders, 2022) for I-ER SUPPORT
Description
Changes in the Gender/Sex diversity belief scale. Range 23-161. Higher values equals more positive attitudes toward transgender individuals.
Time Frame
At pre-treatment and at post treatment (week 10)
Title
Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER SUPPORT
Description
Changes in one's ability to recognize emotions. Range 12-60. Higher scores indicates higher ability to recognize and label emotions.
Time Frame
At pre-treatment and at post treatment (week 10)
Title
Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER SUPPORT.
Description
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.
Time Frame
At pre-treatment and at post treatment (week 10)
Title
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Description
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time Frame
At pre-treatment and at post treatment (week 10)
Title
Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT
Description
Changes in the Difficulties in emotion regulation scale, DERS-16. Range 16-80. Lower values equals better outcomes.
Time Frame
Weekly during the treatment (weeks 1-10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Sahlin, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
ANOVA, Karolinska University Hospital, Norra Stationsgatan 69, Plan 4
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Internet-delivered Treatment for Transgender Individuals With Co-occurring Mental Health Problems

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