Nonsuicidal Self InjuryNCT05907421
Emotion Regulation Dysfunctions in NSSI Adolescents in Naturalistic Contexts
An observational study of Nonsuicidal Self Injury and Emotion Regulation, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. Recent studies indicate that prevalence rates are increasing worldwide, in particular under adolescents, indicating a growing public health issue. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonsuicidal Self Injury, Emotion Regulation
- What is being tested?
- Acceptance mindset
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community.
Who may be able to join
- 15-18 years
- right-handed
- normal or corrected normal visual acuity
- meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)
Who cannot join
- diagnosis of borderline personality disorder, major depressive disorder, other psychiatric disorders, etc.
- high suicidal risk
- recent use of medications that can affect neural activity
- have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
- have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China
Chengdu, Sichuan
Lyuan Li, lly_psychology@163.com
About this study
Official title: Altered Neural Activation Patterns During Emotion Regulation in Adolescents With Nonsuicidal Self-Injury Under Naturalistic Immersive Emotional Engagement
Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. Recent studies indicate that prevalence rates are increasing worldwide, in particular under adolescents, indicating a growing public health issue. An impaired ability to regulate negative emotion has been suggested to play a potential role in NSSI behavior. Some recent interventions aim at improving dysfunctional emotion regulation via 'acceptance'. Acceptance represents an objective, nonreactive, nonjudgmental, and calming emotion regulation strategy, partly based on the philosophy of dialectical behavior therapy (DBT) that has been widely used in the clinical treatment of NSSI behaviors. The aim of the present functional magnetic resonance imaging (fMRI) study is to examine whether adolescents with NSSI can implement the acceptance strategy in naturalistic emotional contexts (immersive video clips) and whether they differ from healthy controls in terms of behavioral and neural effects. To this end, the investigators recruit one group of NSSI adolescents (n=40) and one healthy control group (n=40), to compare the subjective emotional experience as well as underlying neural activity as measured by blood oxygenation level-dependent (BOLD) fMRI. The investigators hypothesize that compared to HC, NSSI adolescents will experience stronger negative emotions and show dysregulated neural recruitment of brain systems engaged in emotional reactivity and regulations (e.g. limbic regions, default mode network, and frontal regions).
- Conditions
- Nonsuicidal Self Injury, Emotion Regulation
- Being tested
- Acceptance mindset
- Medical subject headings
- Self-Injurious Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance mindsetBehavioural
Brief training of acceptance versus emotional reactivity as emotion regulation strategy.
| Study group | Role | What they receive |
|---|---|---|
| NSSI | Not described Receives: Behavioral: Acceptance mindset | |
| HC | Not described Receives: Behavioral: Acceptance mindset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative subjective emotional experience as indexed by self-report
Subjects will rate their negative affect on a scale ranging from 1-9 in response to neutral and negative emotional stimuli during normal experience or acceptance. Alterations in the patients will be determined by using ANOVA models with the group (NSSI vs. HC) as a between-subject factor and emotion regulation condition as a within-subject factor.
Measured: About 30 minutes
Neural activity as indexed by BOLD fMRI
Brain activity will be monitored by task-based fMRI. Alterations in the patients will be determined by the experimental groups (NSSI vs. HC) with respect to the emotion regulation conditions.
Measured: About 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start6 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsuicidal Self InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907421
- Sponsor's protocol ID
- BAM_lab_NSSI_01
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Neural Activation Patterns During Emotion Regulation in Adolescents With Nonsuicidal Self-Injury Under Naturalistic Immersive Emotional Engagement
- ClinicalTrials.gov ID
- NCT05907421
- Acronym / sponsor ID
- BAM_lab_NSSI_01
- Conditions
- Nonsuicidal Self Injury, Emotion Regulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jun 2023 (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.
Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. Recent studies indicate that prevalence rates are increasing worldwide, in particular under adolescents, indicating a growing public health issue. An impaired ability to regulate negative emotion has been suggested to play a potential role in NSSI behavior. Some recent interventions aim at improving dysfunctional emotion regulation via 'acceptance'. Acceptance represents an objective, nonreactive, nonjudgmental, and calming emotion regulation strategy, partly based on the philosophy of dialectical behavior therapy (DBT) that has been widely used in the clinical treatment of NSSI behaviors. The aim of the present functional magnetic resonance imaging (fMRI) study is to examine whether adolescents with NSSI can implement the acceptance strategy in naturalistic emotional contexts (immersive video clips) and whether they differ from healthy controls in terms of behavioral and neural effects. To this end, the investigators recruit one group of NSSI adolescents (n=40) and one healthy control group (n=40), to compare the subjective emotional experience as well as underlying neural activity as measured by blood oxygenation level-dependent (BOLD) fMRI. The investigators hypothesize that compared to HC, NSSI adolescents will experience stronger negative emotions and show dysregulated neural recruitment of brain systems engaged in emotional reactivity and regulations (e.g. limbic regions, default mode network, and frontal regions).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSSI | – | Behavioral: Acceptance mindset |
| HC | – | Behavioral: Acceptance mindset |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community.
Key inclusion criteria (4 listed)
- 15-18 years
- right-handed
- normal or corrected normal visual acuity
- meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)
Key exclusion criteria (5 listed)
- diagnosis of borderline personality disorder, major depressive disorder, other psychiatric disorders, etc.
- high suicidal risk
- recent use of medications that can affect neural activity
- have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
- have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
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 |
|---|---|---|
| Acceptance mindsetBrief training of acceptance versus emotional reactivity as emotion regulation strategy. | Behavioural | HC, NSSI |
Primary outcome
Negative subjective emotional experience as indexed by self-report
Time frame: About 30 minutes
Subjects will rate their negative affect on a scale ranging from 1-9 in response to neutral and negative emotional stimuli during normal experience or acceptance. Alterations in the patients will be determined by using ANOVA models with the group (NSSI vs. HC) as a between-subject factor and emotion regulation condition as a within-subject factor.
Neural activity as indexed by BOLD fMRI
Time frame: About 30 minutes
Brain activity will be monitored by task-based fMRI. Alterations in the patients will be determined by the experimental groups (NSSI vs. HC) with respect to the emotion regulation conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsuicidal Self Injury and Emotion Regulation, run by University of Electronic Science and Technology of China at 1 site in China.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Becker (+86.028-61830867, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative subjective emotional experience as indexed by self-report (time frame: About 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.