Neuroplastic Adaptations in Youth at High Risk for Developing Psychopathology

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Emotion Regulation

Intervention / Treatment
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* Behavioral: Emotion Regulation Skills + Treatment as Usual
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion Regulation Skills + Treatment as Usual<br>Emotion Regulation Skills (ERS), a version of Dialectical Behaviour Therapy Skills Training, is a type of skills-focused therapy for individuals who experience severe emotion dysregulation. | Behavioral: Emotion Regulation Skills + Treatment as Usual<br>* 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.<br>|
| Active Comparator: Treatment as Usual<br>Treatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc. | Behavioral: Treatment as Usual<br>* Treatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate (Feasibility Threshold) | Assessed by the total number of participants recruited from one site during the recruitment period (i.e., Is one site sufficient for recruitment or will the larger study require additional sites or strategies to recruit the necessary sample size? Is it plausible to recruit the required number of TGD individuals?) | 14 weeks | 
| Eligibility Participants (Feasibility Threshold) | Assessed by changes in the baseline number of participants contacted to the number of failed screening assessments (i.e., Are the criteria too narrow? What is the rate of individuals being contacted to participate in the study, but failing screening assessments?) | 14 weeks | 
| Length of Completion of Procedures (Feasibility Threshold) | Assessed by comparing the actual time required per session to the anticipated 3-hour allotment for assessments (i.e., Is the actual time required per study visit different from what is anticipated?) | 14 weeks | 
| Location Logistics (Feasibility Threshold) | Assessed by subjective evaluation and feedback from the research assistant (i.e., Are there unforeseen difficulties due to the Imaging Research Centre being located in a different place than the YWC?) | 14 weeks | 
| Attrition Rate (Feasibility Threshold) | Assessed by changes from the baseline number of participants to those retained at 14 weeks (i.e., What percentage of individuals drop out of ERS and the study?) | 14 weeks | 
| Intervention Attendance Rates (Feasibility Threshold) | Assessed by comparing the number of sessions attended to the total number of sessions allocated (i.e., On average, how many ERS sessions do individuals attend?) | 14 weeks | 
| Burdensomeness of Study Procedures (Feasibility Threshold) | Assessed by subjective evaluation provided by study participants (i.e., Are study procedures too lengthy or onerous for participants?) | 14 weeks | 
| Research Impact on the Youth Wellness Centre (YWC) | Assessed by a subjective review and feedback from the clinical team, up to 14 weeks (i.e., How do YWC staff perceive the impact of research procedures on their own logistics?) | 14 weeks | 
| Communication between Clinical and Research staff | assessed by subjective review and feedback from the clinical team, up to 14 weeks | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Dysregulation and other relevant symptoms/conditions | Changes in the Difficulties in Emotion Regulation Scale (DERS) from baseline to 14 weeks; compared within (pre and post) and between groups (ERS and TAU) The DERS is a 36-item, self-report measure of emotion dysregulation with a 5-point Likert scale (1 = almost never to 5 = almost always). Improvement of 20% or greater on the DERS will be considered significant clinical improvement. | 14 weeks | 
| Resting-state functional connectivity (rs-FC) | Changes in blood-oxygen-level-dependent (BOLD) signal (measured by fMRI) from baseline to 14 weeks; compared within (pre and post) and between groups (ERS and TAU) | 14 weeks | 
| Emotion Dysregulation and brain connectivity between limbic and prefrontal brain areas | Changes in the DERS scale compared to changes in blood-oxygen-level-dependent (BOLD) signal (measured by fMRI) in the limbic and prefrontal brain regions from baseline to 14 weeks; compared within (pre and post) and between groups (ERS and TAU) | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroplastic Adaptations, Psychopathology