Clinical trial NCT06858540: Blended Unified Protocol in Chinese Adolescents With Non-Suicidal Self-Injury
Official title: A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-suicidal Self-injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-suicidal Self-injury (NSSI)
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) to address non-suicidal self-injury among Chinese adolescents. This program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. Its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. In turn, this helps reduce self-injury impulses and behaviors. The UP-A is adapted to the Chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions. The study will assess the feasibility, acceptability, and preliminary efficacy of this intervention through a single-arm design, which includes pretest, posttest, and follow-up assessments.

Detailed description: The blended UP-A includes 8 weekly modules, 6 of which (Module 2 - 7)are online self-guided sessions. The online self-guided sessions will last approximately 45 minutes each. Over the course of these 6 weeks, participants will also have 6 therapist-guided online sessions via videoconference, each lasting 30 minutes. Two face-to-face individual sessions are scheduled, one at the beginning of each (Module 1) and one at the end (module 8), each with an expected duration of 90 minutes.

Eligibility criteria: Inclusion Criteria:

1. Aged between 12 and 17 years;
2. Engaged in non-suicidal self-injury (NSSI) at least 5 times in the past 12 months, with at least 1 episode in the past month;
3. Minimum education level of primary school or above;
4. Participant and guardian fully understand the research content and agree to participate, with signed informed consent provided.

Exclusion Criteria:

1. Suicide attempts in the past month or a score of ≥17 on the MINI National Neuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk of suicide;
2. Diagnosis of a psychotic disorder, manic or hypomanic episode, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;
3. Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;
4. Currently receiving other professional psychotherapy or participating in another NSSI intervention study;
5. Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;
6. Having received electroconvulsive therapy (ECT) within the past 6 months.

Primary outcomes:
measure: Adherence
timeFrame: Immediately after the intervention
measure: Dropout rates
timeFrame: Immediately after the intervention
measure: The Feasibility and Acceptability Questionnaire (FAQ)
timeFrame: Immediately after the intervention
measure: Participants' perspectives on the intervention
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Non-suicidal self-injury
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
measure: Emotion dysregulation
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
measure: Emotion regulation strategies
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
measure: Depression
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
measure: Anxiety
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
Other outcomes:
measure: Basic psychological need satisfaction and frustration
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
measure: Neuroticism
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
measure: Distress tolerance
timeFrame: baseline, immediately after the intervention, and 1-month after the intervention
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital
state: Hunan
Study officials:
References: