Clinical trial NCT06966193: Co-Producing LGBTQ-Affirmative DBT Protocols.
Official title: Co-Producing LGBTQ-Affirmative Intervention Protocols for LGBTQ+ People at Risk of Self-Harm and Suicide: A Co-Production Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Self-Harm
Suicidal
Emotional Dysregulation
Keywords: LGBTQ+
DBT
Self-Harm
Suicidal Behaviours
Emotion Dysregulation
Young People
Sexual Minorities
Gender Minorities
Co-Production
Adolescents
Therapists
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2025-05-11
Enrollment: 32
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DBT Cohort Young Person Sample 1 Young people will be recruited via purposive sampling via the National \& Specialist CAMHS DBT Service and the adult DBT service within South London \& Maudsley NHS Foundation Trust.

Non-DBT Cohort Young Person Sample 2 Young people will be recruited from CAMHS within South London \& Maudsley NHS Foundation Trust and from community organisations (e.g. LGBTQ+ charities) and general advertising on social media and similar.

DBT Therapists DBT therapists will be recruited via purposive sampling via the National \& Specialist CAMHS DBT Service and Adult DBT Services in South London \& Maudsley NHS Foundation Trust.

Brief summary: Aims:

1. To co-produce new intervention parts that meet the needs of LGBTQ+ people at risk of self-harm or suicidal thoughts, with LGBTQ+ people and DBT therapists. These intervention parts will be integrated into a Dialectical Behaviour Therapy (DBT) intervention, that is provided earlier in a persons mental health care journey, than DBT is usually targeted at.
2. To assess how acceptable and feasible the co-production process was for participants, and how well it achieved co-production principles (e.g. participants feel supported, that the aims were transparent, etc).

Why is This Important? Young people who identify as lesbian, gay, bisexual, transgender, queer, and with other minoritised gender and sexual identities (LGBTQ+) are much more likely to self-harm and experience suicidal thoughts than cisgender-heterosexual (non-LGBTQ+) people. They also experience barriers when accessing mental health support. Some of these barriers come from a lack of support tailored towards their needs as an LGBTQ+ person. This often means that things get worse before they access the right support, and so are often seen in higher-intensity interventions (tier 4 or tertiary care), like DBT.

What The Investigators Plan to Do:

The investigators plan to hold some focus groups with three different groups of people to co-produce the new intervention parts. The three groups include:

1. A group of LGBTQ+ young people (13-21 years old) who have completed a at full DBT programme recently.
2. A group of LGBTQ+ young people (13-21 years old) who have never been in a full DBT programme but experienced similar difficulties.
3. A group of DBT therapists who have supported LGBTQ+ young people before.

The investigators will seek feedback from participants about how acceptable they found the study (e.g. how satisfied they were with the process), how feasible it was (e.g. were they able to attend and was it practice?), and how well they stuck to the coproduction principles (e.g. how supported they felt).


Eligibility criteria: DBT Cohort Young Person Sample 1

Inclusion criteria will include that the young person:

1. Is aged 13 to 21 years old;
2. has completed at least four months of comprehensive DBT (i.e. inclusive of all four modes of intervention; Linehan, 1993; Miller et al., 2006; Rathus \& Miller, 2015) in the past 24 months or have completed at least four months of DBT and are still in a comprehensive DBT programme;
3. identifies as LGBTQ+ (including those questioning or unsure about their orientation/identity);
4. is willing and able to participate in the study. While no specific inclusion or exclusion criteria will be placed on other variables, typically to be eligible for a DBT programme, young people would need to have a history of self-harm and/or suicidal behaviours, difficulties with emotion regulation, and potentially difficulties with the remaining symptom list within borderline/emotionally unstable personality disorder. Recruitment size is based on PPI recommendations regarding effective group sizes, with allowances for sample attrition.

Non-DBT Cohort Young Person Sample 2

Inclusion criteria will follow similar to sample 1. The young person:

1. Is aged 13 to 21 years old;
2. has not accessed and is not currently enrolled in a comprehensive DBT programme;
3. has experienced difficulties with LGBTQ-related identity confusion, managing stigma experiences, and connecting with similar others;
4. identifies as LGBTQ+ (including those questioning or unsure about their orientation/identity);
5. is willing and able to participate in the study (i.e. are based in the UK and can attend the in-person and online groups).

No other inclusion or exclusion criteria will be systematically implemented for this group.

DBT Therapist Sample

Inclusion criteria:

1. Currently practicing or having completed (or recently finished, within the past 12 months) a comprehensive DBT programme as a DBT therapist. In order to practice as a DBT therapist, they must hold a professional qualification recognised by appropriate healthcare regulators.
2. Having experience working with at least one LGBTQ+ client in DBT, who was aged between 13 and 21 years at the time.
3. Being willing and able to participate in the study.

Primary outcomes:
measure: Feasibility/Recruitment
timeFrame: Baseline
measure: Feasibility/Attrition
timeFrame: Baseline, during the focus groups (12 weeks in duration), and at outcome measure completion (12 weeks from baseline)
measure: Feasibility/Focus Group Content and Delivery
timeFrame: For the duration of the focus groups (12 weeks)
measure: Acceptability/Session Satisfaction
timeFrame: At the end of each focus group (6 focus groups over 12 weeks)
measure: Acceptability/Satisfaction with the Study
timeFrame: End of Study (12 weeks post baseline)
measure: Acceptability/Recommend to Others
timeFrame: End of study (12 weeks post baseline)
measure: Acceptability/Helpfulness
timeFrame: End of study (12 weeks post baseline)
measure: Acceptability/Engagement
timeFrame: End of study (12 weeks post baseline)
measure: Acceptability/Cultural Sensitivity
timeFrame: End of study (12 weeks post baseline)
measure: Feasibility/General
timeFrame: End of study (12 weeks post baseline)
measure: Feasibility/Practicalities
timeFrame: End of study (12 weeks post baseline)
Secondary outcomes:
measure: Wellbeing
timeFrame: End of study (12 weeks post baseline)
measure: Co-Production Process/Respect
timeFrame: End of study (12 weeks post baseline)
measure: Co-Production Process/Support
timeFrame: End of study (12 weeks post baseline)
measure: Co-production Process/Transparency
timeFrame: End of study (12 weeks post baseline)
measure: Co-Production Process/Responsiveness
timeFrame: End of study (12 weeks post baseline)
measure: Co-Production Process/Fairness of Opportunities
timeFrame: End of study (12 weeks post baseline)
measure: Co-production Process/Accountability
timeFrame: End of study (12 weeks post baseline)
measure: Co-Production/Empowerment
timeFrame: End of study (12 weeks post baseline)
Other outcomes:
Locations:
Study officials:
References: