CompletedNot Applicable

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

Sweden24 participantsStarted 2022-08-24

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants recruited to I-ER GD.

Timeframe: At pretreatment.

Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD

Timeframe: At post-treatment (week 12).

The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.

Timeframe: At treatment week 2.

The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.

Timeframe: At post-treatment (week 12).

The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD

Timeframe: At mid-treatment (week 5).

The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD

Timeframe: At post-treatment (week 12).

Number of participants recruited to I-ER SUPPORT.

Timeframe: At pretreatment.

The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT

Trial details

NCT IDNCT05534763

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Gender Dysphoria trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants recruited to I-ER GD.

Timeframe: At pretreatment.

Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER GD

Timeframe: At post-treatment (week 12).

The Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000) in I-ER GD.

Timeframe: At treatment week 2.

The Negative effects Questionnaire (NEQ; Rozental et al. 2016) in I-ER GD.

Timeframe: At post-treatment (week 12).

The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD

Timeframe: At mid-treatment (week 5).

The internet intervention Patient Adherence Scale (iiPAS; Lenhard et al. 2019) in I-ER GD

Timeframe: At post-treatment (week 12).

Number of participants recruited to I-ER SUPPORT.

Timeframe: At pretreatment.

The Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982) in I-ER SUPPORT