Emotion RegulationNCT05586425
Neuroplastic Adaptations in Youth at High Risk for Developing Psychopathology
A study testing Emotion Regulation Skills + Treatment as Usual and Treatment as Usual in people with Emotion Regulation, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 24 years
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Emotion Regulation Skills + Treatment as Usual and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Emotion Regulation
- Being tested
- Emotion Regulation Skills + Treatment as Usual, Treatment as Usual
- Keywords
- Neuroplastic Adaptations, Psychopathology
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Skills + Treatment as UsualBehavioural
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.
Treatment as UsualBehavioural
Treatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?)
Measured: 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?)
Measured: 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?)
Measured: 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?)
Measured: 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?)
Measured: 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?)
Measured: 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?)
Measured: 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?)
Measured: 14 weeks
Communication between Clinical and Research staff
assessed by subjective review and feedback from the clinical team, up to 14 weeks
Measured: 14 weeks
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maiko Schneider, MD/PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586425
- Sponsor's protocol ID
- 13517
- Status last verified
- Oct 2022
- First submitted
- 21 Jul 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25482858Gratz 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.
PubMed 27709991
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05586425
- Acronym / sponsor ID
- 13517
- Conditions
- Emotion Regulation
- Keywords
- Neuroplastic Adaptations, Psychopathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Skills + Treatment as Usual | Experimental | Behavioral: Emotion Regulation Skills + Treatment as UsualEmotion 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. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc. |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation Skills + Treatment as UsualERS 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. | Behavioural | Emotion Regulation Skills + Treatment as Usual |
| Treatment as UsualTreatment as Usual entails psychiatric medication management, psychiatric management, individual support from peer mentors, drop-in activity groups, etc. | Behavioural | Treatment as Usual |
Primary outcome
Recruitment Rate (Feasibility Threshold)
Time frame: 14 weeks
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?)
Eligibility Participants (Feasibility Threshold)
Time frame: 14 weeks
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?)
Length of Completion of Procedures (Feasibility Threshold)
Time frame: 14 weeks
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?)
Location Logistics (Feasibility Threshold)
Time frame: 14 weeks
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?)
Attrition Rate (Feasibility Threshold)
Time frame: 14 weeks
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?)
Intervention Attendance Rates (Feasibility Threshold)
Time frame: 14 weeks
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?)
Burdensomeness of Study Procedures (Feasibility Threshold)
Time frame: 14 weeks
Assessed by subjective evaluation provided by study participants (i.e., Are study procedures too lengthy or onerous for participants?)
Research Impact on the Youth Wellness Centre (YWC)
Time frame: 14 weeks
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?)
Communication between Clinical and Research staff
Time frame: 14 weeks
assessed by subjective review and feedback from the clinical team, up to 14 weeks
3 secondary outcomes
Emotion Dysregulation and other relevant symptoms/conditions
Time frame: 14 weeks
Resting-state functional connectivity (rs-FC)
Time frame: 14 weeks
Emotion Dysregulation and brain connectivity between limbic and prefrontal brain areas
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Background: PubMed 25482858O'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.
- Background: PubMed 27709991Gratz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiko Schneider, MD/PhD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Skills + Treatment as Usual and Treatment as Usual in people with Emotion Regulation, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maiko Schneider, MD/PhD (905-522-1155 ext. 39159, mschneid@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (Feasibility Threshold) (time frame: 14 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05586425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.