Research question:To what extent is a web-based, Cognitive Behavioral Therapy (CBT) specially designed for young gender diverse youth in the Netherlands, an effective treatment to reduce their suicidality? Are there gender, sex assigned at birth,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
suicidaliteit en minderheidsstress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters for primary objectives are suicidal ideation and
behavior, depression, gender minority stress, genderdysphoria and coping.
Secondary outcome
Main study parameters for secondary objectives are thwarted belongingness and
perceived burdensomeness. Secondary parameters are explicit rejection due to
gender identity.
Background summary
The high rate of suicidality among transgender and gender diverse youth
(hereafter "gender diverse") is a serious mental and public health issue.
Gender diverse youth have a 7-10-fold risk of suicidality. Adolescence and
young adulthood are peak periods for mental health problems among gender
diverse people: 93.0% of first suicide attempts in this group occur before the
age of 25.
The mechanisms that can explain the increased suicidality of gender diverse
youth occur from within a 1) gender minority stress framework and a 2) gender
dysphoria framework. These frameworks show that gender minority individuals can
experience internal and external stress, as well as dysphoria around their
gender identity. (Testa et al., 2015).
Trying to understand what is happening in relation to their gender identity and
seeking confirmation of their gender identity, both internally and from their
environment (where rejection often takes place), enhances youth*s psychological
complaints and suicidality. The proposed
treatment therefore aims to address the combined burden of having suicidal
thoughts, experiencing gender minority stress and gender dysphoria, and offer
helpful coping skills.
Study objective
Research question:
To what extent is a web-based, Cognitive Behavioral Therapy (CBT) specially
designed for young gender diverse youth in the Netherlands, an effective
treatment to reduce their suicidality? Are there gender, sex assigned at birth,
age (and ethnicity) differences when comparing transgender males, transgender
females and non-binary young people?
Objective: Primary objectives. We aim to investigate: (1) the extent to which a
web-based CBT specifically developed gender diverse youth, aged between 16 and
28, is more effective in reducing a) suicidal ideation, b) depression, and c)
gender minority stress than treatment as usual. And (2), we aim to investigate
the extent to which this web-based CBT helps to decrease participants*
maladaptive coping strategies and increase participants* adaptive coping
strategies for dealing with minority stress and suicidality.
Secondary objectives. We aim to investigate if: (3) there are group differences
in intervention effects. And (4) suicidal ideation is reduced through
decreasing thwarted belongingness and perceived burdensomeness.
Study design
We will utilize a single blind randomized controlled trial: participants will
be randomly assigned to either the control condition (treatment as usual) or
the experimental condition. Participants are blind to the condition.
Study population Gender diverse youth aged 16 - 28 with suicidal ideation or
suicidal behavior. Youth who are unsure about their gender identity will also
be able to participate. The experimental and control condition will be
delivered by approximately 15 psychologists from 113 Suicide Prevention.
The experimental condition is a web-based CBT intervention. This treatment
consists of 12 weekly chat or phone sessions of approximately an hour with a
psychologist.
The control condition is the treatment as usual delivered by psychologist from
113 Suicide Prevention. In the treatment as usual participants also receive 12
weekly chat sessions of approximately an hour.
The difference between the experimental condition and the control condition
consists of the focus and contents on *genderdyphoria, gender minority stress,
and coping with these aspects*, which is only visible in the experimental
condition.
Main study parameters/endpoints:
Main study parameters for primary objectives are suicidal ideation and
behavior, depression, gender minority stress, genderdysphoria and coping. Main
study parameters for secondary objectives are thwarted belongingness and
perceived burdensomeness. Secondary parameters are explicit rejection due to
gender identity.
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
There is no added risk for participants participating in one of our conditions
compared to the treatment as usual condition as provided by 113 to this
population. Research shows that participating in a randomized controlled trial
aimed at reducing suicidality does not increase the risk of suicide (Huisman &
Kerkhof, 2017). In addition, in both conditions participants receive treatment
for their suicidal ideation by trained psychologists. However, in the
experimental condition, we have a specific focus on genderdyphoria, gender
minority stress, and coping with these aspects*. In the study (and different
from treatment as usual), participants (in both conditions) are asked to
complete a total 60-92 items at four times points: before the first session
(T0; 92 items), after the seventh session (T1; 60 items), after the last
session (T2; 60 items) and three months after the last session (T3; 80 items).
The questions ask, among other things, about suicidal ideation, gender
dysphoria coping and minority stress. Research showed that answering questions
regarding suicidality does not increase suicidal ideation (Huisman & Kerkhof,
2017), and therefore does not pose a risk to participants.
Study burden and risks
There is no added risk for participants participating in one of our conditions
compared to the treatment as usual condition as provided by 113 to this
population. Research shows that participating in a randomized controlled trial
aimed at reducing suicidality does not increase the risk of suicide (Huisman &
Kerkhof, 2017). In addition, in both conditions participants receive treatment
for their suicidal ideation by trained psychologists. However, in the
experimental condition, we have a specific focus on genderdyphoria, gender
minority stress, and coping with these aspects*. In the study (and different
from treatment as usual), participants (in both conditions) are asked to
complete a total 60-92 items at four times points: before the first session
(T0; 92 items), after the seventh session (T1; 60 items), after the last
session (T2; 60 items) and three months after the last session (T3; 80 items).
The questions ask, among other things, about suicidal ideation, gender
dysphoria coping and minority stress. Research showed that answering questions
regarding suicidality does not increase suicidal ideation (Huisman & Kerkhof,
2017), and therefore does not pose a risk to participants.
Grote Kruisstraat 2/1
Groningen 9733TG
NL
Grote Kruisstraat 2/1
Groningen 9733TG
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- A subject is aged between 16 - 28 years old.
- A subject identifies as one of the identities we classify under *gender
diverse* (see 4.1) or is not sure about their gender identity.
- A subject is having suicidal ideation
[Nb: if subjects already follow a therapy elsewhere, we will include them but
within the sessions also gives them tools to discuss their suicidal thoughts
with their current mental healthcare provider]
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Subjects who are in acute suicidal crisis. They will be able to discuss this
with their 113 therapist when they have a meeting scheduled, or they contact
the crisis chat of 113 Suicide Prevention. All potential subjects are informed
of this at several points in the online registration environment, and in the
recruitment material. It will be discussed with the participants if it still
feasible and sensible to continue their enrolment in the therapy.
- Subjects who seem to be confused or mentally incapacitated The assessment of
an individual's eligibility to participate will be made by the therapist in
consultation with their supervisor. Those unable to follow therapy will be
excluded.
- - When a subject starts or is already enrolled in new therapy somewhere else,
the psychologist decides together with the participant if this therapy
continues. Participants who do attend other therapy more frequently than once
every three weeks will be excluded or that the 113 therapy will be finished.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85970.018.23 |