Internet-delivered Emotion Regulation Treatment (I-ER GD) for Transgender Adults and Co-occurring Mental Health Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
IERGD
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.
干预措施: IERGD (Behavioral)
IER SUPPORT
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.
干预措施: IER SUPPORT (Other)
结局指标
主要结局
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.
时间窗: 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
时间窗: 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 GD.
时间窗: At pretreatment.
Measures will include recruitment rate during study inclusion period (0-30 participants).
Number of participants recruited to I-ER SUPPORT.
时间窗: 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
时间窗: At post-treatment (week 10).
Measures treatment satisfaction. Range 8-32, higher values equals higher satisfaction with treatment.
The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER SUPPORT.
时间窗: 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.
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD
时间窗: 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.
时间窗: At treatment week 2.
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER SUPPORT
时间窗: At treatment week 2.
Measures treatment credibility and expectancy for positive change. Range 0-5, higher values equals higher treatment credibility and expectancy.
The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD
时间窗: At mid-treatment (week 5).
Measures adherence to treatment at two timepoints of the treatment. Range 0-20. Higher scores indicate better adherence.
次要结局
- Changes in Deliberate Self-Harm Inventory (DSHI-9; Lundh, Karim & Quillisch 2007) for I-ER GD(Weekly during the treatment (weeks 1-11))
- Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER GD.(Weekly during the treatment (weeks 1-11))
- Changes inThe Drug Use Disorders Identification Test (DUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.(At baseline and at post treatment (week 12))
- Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD(Weekly during the treatment (weeks 1-11))
- Changes in Perceived Stress Scale (PSS-14; Cohen, Kamarck & Mermelstein 1983) for I-ER GD(At pre-treatment and at post treatment (week 12))
- Changes in Montgomery Åsberg Depression Rating Scale (MADRS-S; Montgomery & Åsberg 1979) for I-ER GD(At pre-treatment and post treatment (week 12))
- Changes inThe Alcohol Use Disorders Identification Test (AUDIT; Berman, Wennberg & Källmén, 2012) for I-ER GD.(At baseline and at post treatment (week 12))
- Changes in Brunnsviken Brief Quality of Life Inventory (BBQ; Lindner et al, 2016) for I-ER GD(At pre-treatment and at post treatment (week 12))
- Changes in Rumination Response Scale (RRS-10; Nolen-Hoeksema, Morrow 1991) for I-ER GD(At pre-treatment and at post treatment (week 12))
- Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER GD(At pre-treatment and at post treatment (week 12))
- Changes in Gender minority stress and resilience (GMSR, Testa et al 2014) for I-ER GD.(At pre-treatment and at post treatment (week 12))
- Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER GD.(At pre-treatment and at post treatment (week 12))
- Changes in Gender Congruence and Life Satisfaction Scale (GCLS; Dhejne et al. 2019) for I-ER GD(At baseline and at post treatment (week 12))
- Changes in Work and social adjustment scale (WSAS; Marks 1986) for I-ER GD(At baseline and at post treatment (week 12))
- Changes in The Difficulties in emotion regulation scale, (DERS-16; Gratz & Roemer, 2004) for I-ER SUPPORT(Weekly during the treatment (weeks 1-10))
- Changes in Satisfaction With Life, Swedish (SWLS; Diener 1985) for I-ER GD(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(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(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(At pre-treatment and at post treatment (week 10))
- Changes in Affect Labeling Questionnaire (ALQ; Sahi et al, in prep.) for I-ER SUPPORT(At pre-treatment and at post treatment (week 10))
- Changes in The Emotion Regulation Questionnaire, (ERQ; Gross & John, 2003) for I-ER SUPPORT.(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 GD.(At pre-treatment and at post treatment (week 12))
- Changes in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke 1998) for I-ER GD(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(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 SUPPORT(At pre-treatment and at post treatment (week 10))
研究者
Hanna Sahlin
Principal investigator
Karolinska Institutet