Clinical trial NCT05586425: Neuroplastic Adaptations in Youth at High Risk for Developing Psychopathology
Official title: Neuroplastic Adaptations in Youth at High Risk for Developing Psychopathology: A Randomized Controlled Trial Modelling Feasibility and Clinical Improvement Following ERS Training With Changes in Brain Connectivity and Anatomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotion Regulation
Keywords: Neuroplastic Adaptations
Psychopathology
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pilot study aims to inform decision-making for a bigger study we intend to conduct in the future. The larger investigation will explore how helpful a treatment program for youth (ages 17 - 24) with emotion dysregulation (ED) is, as well as how this program affects the brain. The current pilot study will also explore these topics, but on smaller scale.The treatment program we are researching is called Emotion Regulation Skills (ERS). It is based on Dialectical Behaviour Therapy Skills Training (DBT-ST), a type of skills-focused therapy for individuals who experience severe ED. ERS has been updated to be friendlier to youth and involves learning skills for how to: (1) be more present in the moment, (2) effectively manage and respond to emotional experiences, (3) communicate your needs to others, and (4) increase your ability to tolerate distress.

Detailed description: Emotion dysregulation (ED), described as an individual's inability to respond to and cope with their emotions, has been linked to many serious mental health problems, including substance use and suicide. Minority stress, defined as the additional stress that members of marginalized groups experience because of the prejudice and discrimination they face, is also believed to be linked with ED. Youth are particularly prone to developing ED. As such, it is important to offer evidence-based treatment interventions to this age group in order to offset problems associated with ED and promote mental wellness in adulthood. Dialectical Behaviour Therapy Skills Training (DBT-ST) is proven to be an effective intervention for reducing ED in youth. This pilot study will offer a 14-week, youth-friendly version of DBT-ST, called Emotion Regulation Skills (ERS), to youth with ED. Half of the participants in this study will complete ERS in the Youth Wellness Centre (YWC) at St. Joseph's Healthcare Hamilton (SJHH), in addition to receiving all interventions typically associated with treatment as usual (TAU). The other half will be placed on a waitlist for ERS, and will only receive TAU for 14 weeks. After 14 weeks, the TAU group will be crossed over into the intervention condition, at which point they will also receive ERS. The primary purpose of this pilot study will be to assess the feasibility of a larger study to measure clinical improvement in youth who participate in ERS. As secondary objectives, this pilot study will also collect data on clinical and brain-based outcomes following ERS. For this study, all participants will be asked to undergo fMRI neuroimaging and respond to specific questionnaires about their levels of ED and other mental health symptoms before and after 14 weeks of ERS or TAU. Participants in the TAU group will undergo a third session of fMRI neuroimaging and respond to questionnaires after they have also completed ERS, 14 weeks after being crossed over into the intervention condition (i.e., 28 weeks after their first neuroimaging/questionnaires). It is expected that ERS will improve ED more than TAU after 14 weeks, and that these changes will be evident at the brain level. It is also expected that these changes will be greater in cisgender individuals than in transgender and gender diverse (TGD) individuals, who are at greater risk for experiencing minority stress related to their gender identity.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 17 and 24 years, inclusive
* Difficulties in Emotion Regulation Scale score \>96 at baseline
* Able to provide written informed consent and communicate in English

Exclusion Criteria:

* Diagnosis of an active substance use disorder (SUD)
* Diagnosis of an organic brain disorder
* Lifetime history of a psychotic disorder (e.g., bipolar affective disorder, schizophrenia, schizoaffective disorder, etc.)
* Active PTSD symptoms
* Currently using antidepressants, only if the last adjustment in dose was within 3 months of beginning the study
* Has received standard DBT treatment in the past 2 years
* MRI contraindications

Primary outcomes:
measure: Recruitment Rate (Feasibility Threshold)
timeFrame: 14 weeks
measure: Eligibility Participants (Feasibility Threshold)
timeFrame: 14 weeks
measure: Length of Completion of Procedures (Feasibility Threshold)
timeFrame: 14 weeks
measure: Location Logistics (Feasibility Threshold)
timeFrame: 14 weeks
measure: Attrition Rate (Feasibility Threshold)
timeFrame: 14 weeks
measure: Intervention Attendance Rates (Feasibility Threshold)
timeFrame: 14 weeks
measure: Burdensomeness of Study Procedures (Feasibility Threshold)
timeFrame: 14 weeks
measure: Research Impact on the Youth Wellness Centre (YWC)
timeFrame: 14 weeks
measure: Communication between Clinical and Research staff
timeFrame: 14 weeks
Secondary outcomes:
measure: Emotion Dysregulation and other relevant symptoms/conditions
timeFrame: 14 weeks
measure: Resting-state functional connectivity (rs-FC)
timeFrame: 14 weeks
measure: Emotion Dysregulation and brain connectivity between limbic and prefrontal brain areas
timeFrame: 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Maiko Schneider, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Neill A, D'Souza A, Samson AC, Carballedo A, Kerskens C, Frodl T. Dysregulation between emotion and theory of mind networks in borderline personality disorder. Psychiatry Res. 2015 Jan 30;231(1):25-32. doi: 10.1016/j.pscychresns.2014.11.002. Epub 2014 Nov 13.
citation: Gratz KL, Moore KE, Tull MT. The role of emotion dysregulation in the presence, associated difficulties, and treatment of borderline personality disorder. Personal Disord. 2016 Oct;7(4):344-353. doi: 10.1037/per0000198.