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Trial · NCT07885579

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPsychological Distressbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Psychological distress will be assessed using the 6-item Kessler Psychological Distress Scale (K6). Each item is rated on a 5-point frequency scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 24, with higher scores indicating greater psychological distress.
PrimaryCatastrophizingbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Catastrophizing will be assessed using the catastrophizing subscale of the 18-item Cognitive Emotion Regulation Questionnaire (CERQ-18). The CERQ-18 consists of nine 2-item subscales. Each item is rated on a 5-point scale from 1 to 5. The two catastrophizing items are summed to produce a subscale score ranging from 2 to 10, with higher scores indicating more frequent use of catastrophizing as a cognitive emotion regulation strategy.
PrimarySelf-Esteembaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Global self-esteem will be assessed using the 10-item Rosenberg Self-Esteem Scale (RSES). Each item is rated on a 4-point scale from 1 to 4, with negatively worded items reverse-scored. Item scores are summed to produce a total score ranging from 10 to 40, with higher scores indicating higher levels of global self-esteem.
PrimaryEmotional claritybaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Emotional clarity will be assessed using the Lack of Emotional Clarity subscale of the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). The subscale consists of two items, each rated on a 5-point scale from 1 to 5. Item scores are summed to yield a total score ranging from 2 to 10, with higher scores indicating greater difficulties in emotional clarity.
SecondaryDepressive Symptomsbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is rated according to symptom frequency over the preceding 2 weeks on a 4-point scale from 0 (not at all) to 3 (nearly every day). Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
SecondaryAnxiety Symptomsbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is rated according to symptom frequency over the preceding 2 weeks on a 4-point scale from 0 (not at all) to 3 (nearly every day). Item scores are summed to produce a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
SecondaryEating Disorder Symptomsbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Eating disorder symptoms will be assessed using the Chinere version of the 12-item Eating Disorder Examination Questionnaire-Short Form (EDE-QS). Each item is scored from 0 to 3. Item scores are summed to produce a total score ranging from 0 to 36, with higher scores indicating greater severity of eating disorder symptoms.
SecondaryInsomnia Severitybaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Insomnia symptoms will be assessed using the 7-item Insomnia Severity Index (ISI). Each item is rated on a 5-point scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 28, with higher scores indicating greater insomnia severity.
SecondarySomatic Symptom Severitybaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Somatic symptoms will be assessed using the 15-item Patient Health Questionnaire (PHQ-15). Each item is rated on a 3-point scale from 0 (not bothered at all) to 2 (bothered a lot). Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater somatic symptom severity.
SecondarySuicidal Ideationbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Suicidal ideation will be assessed using the first five screening items of the Beck Scale for Suicide Ideation (BSS). Each item assesses suicidal thoughts and attitudes over the preceding week, and is rated on a 3-point scale from 0 to 2. Item scores are summed to produce a total score ranging from 0 to 10, with higher scores indicating greater severity of suicidal ideation.
SecondarySelf-Injurious Behaviorbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Self-injurious behavior will be assessed using four self-developed items. These items assess whether participants engaged in self-injury during the preceding week, the frequency of self-injurious acts, the number of days on which self-injury occurred, and the perceived likelihood of engaging in self-injury again. Higher values indicate more frequent self-injury or greater perceived likelihood of future self-injury.
SecondaryUrges to Engage in Self-Injurybaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Urges to engage in self-injury will be assessed using the 5-item Alexian Brothers Urge to Self-Injure Scale (ABUSI). The scale assesses the frequency, intensity, duration, difficulty resisting, and overall severity of self-injury urges over the preceding week. Each item is rated on a 7-point scale from 0 to 6. Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater severity of self-injury urges.
SecondaryUrgencybaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Negative and positive urgency will be assessed using the Negative Urgency and Positive Urgency subscale of the Short UPPS-P Impulsive Behavior Scale (SUPPS-P), respectively. Each subscale contains 4 items rated on a 4-point scale from 1 to 4. After appropriate reverse scoring, the four items are summed to produce a score ranging from 4 to 16, with higher scores indicating a greater tendency to act impulsively when experiencing intense emotions.
SecondaryAggressionbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Aggression will be assessed using the 12-item Brief Aggression Questionnaire (BAQ). The scale measures four dimensions of aggression: physical aggression, verbal aggression, anger, and hostility. Each item is rated on a 7-point scale from 1 (extremely uncharacteristic of me) to 7 (extremely characteristic of me). After reverse-scoring the relevant item, scores are summed to produce a total score ranging from 12 to 84, with higher scores indicating greater levels of aggression.
SecondaryFunctional Impairmentbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Functional impairment will be assessed using the Sheehan Disability Scale (SDS). The scale contains 3 items assessing impairment in work or school, social life, and family life or home responsibilities. Each item is rated from 0 to 10. The three items are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater functional impairment.
SecondaryLife Satisfactionbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Life satisfaction will be assessed using the 5-item Satisfaction With Life Scale (SWLS). Each item is rated on a 7-point scale from 1 to 7. Item scores are summed to produce a total score ranging from 5 to 35, with higher scores indicating greater satisfaction with life.
SecondaryStudy Retention Ratepost-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)Study retention will be assessed as the proportion of enrolled participants who complete the post-intervention and follow-up assessment.
SecondaryIntervention acceptabilitypost-treatment (2 weeks)
Intervention acceptability will be assessed using an adapted version of the Chinese Acceptability of Intervention Measure (cAIM). In addition to the original cAIM items, the adapted measure includes items assessing participants' willingness to recommend the intervention to friends and their willingness to continue using the intervention, informed by Wang et al. (2024). All items are rated on a 5-point scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived acceptability of the intervention.
OtherAlcohol Usebaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Alcohol use will be assessed using the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C). The scale assesses alcohol consumption over the preceding 12 months, including drinking frequency, typical quantity of alcohol consumed, and frequency of heavy episodic drinking. Each item is rated on a 5-point scale from 0 to 4. Item scores are summed to produce a total score ranging from 0 to 12, with higher scores indicating greater alcohol consumption and increased risk of hazardous drinking.
OtherExternalizing Behaviorsbaseline, post-treatment (2 weeks), 2-week follow (4 weeks), 4-week follow-up (6 weeks)
Externalizing behaviors will be assessed using an 11-item self-developed questionnaire. The questionnaire assesses the frequency of externalizing behaviors over the preceding 2 weeks, including rule-breaking, verbal and physical aggression, and impulsive behaviors. Each item is rated on a 5-point scale from 0 to 4, with higher scores indicating more frequent occurrence of externalizing behaviors. Item scores are summed to produce a total score ranging from 0 to 44, with higher scores indicating greater levels of externalizing behaviors.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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