Eligibility Module

Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module


Ignite Creation Date: 2025-12-25 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 1:12 AM
NCT ID: NCT06966193
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.
Healthy Volunteers: True
Sex: ALL
Minimum Age: 13 Years
Maximum Age: 21 Years
Study: NCT06966193
Study Brief:
Protocol Section: NCT06966193