Neuroplastic Adaptations in Youth at High Risk for Developing Psychopathology

NCT05586425 | Unknown

• 1 other identifier: 13517
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emotion Regulation

Keywords

Neuroplastic Adaptations; Psychopathology

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Emotion Dysregulation and other relevant symptoms/conditions

  14 weeks

• Resting-state functional connectivity (rs-FC)

  14 weeks

• Emotion Dysregulation and brain connectivity between limbic and prefrontal brain areas

  14 weeks

Study Arms (2)

Emotion Regulation Skills + Treatment as Usual

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc.

Behavioral: Treatment as Usual

Interventions

Emotion Regulation Skills + Treatment as Usual BEHAVIORAL

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.

Emotion Regulation Skills + Treatment as Usual

Treatment as Usual BEHAVIORAL

Treatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc.

Treatment as Usual

Eligibility Criteria

• Age: 17 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Related Publications (2)

• 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.

  PMID: 25482858 BACKGROUND

• 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.

  PMID: 27709991 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Maiko Schneider, MD/PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maiko Schneider, MD/PhD

CONTACT

905-522-1155; mschneid@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: October 19, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-10