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The effectiveness and acceptability of personalized intervention for children and adolescents at risk of anxiety: A single-center, open-label, randomized controlled clinical study

The effectiveness and acceptability of personalized intervention for children and adolescents at risk of anxiety: A single-center, open-label, randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120391
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-13
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Symptoms (Children and Adolescents)

Interventions

Intervention Group:Digital Cognitive Behavioral Therapy (DCBT). An 8-week program with two online structured sessions per week, one lasting about 20 minutes and one lasting about 40 minutes. Core CBT
Active Control Group:An eight-week program featuring two online push notifications per week delivering standardized educational materials. One session takes approximately 40 minutes to complete, and a

Sponsors

Beijing Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 10-18 years; 2. General Anxiety Disorder-7 (GAD-7) score >= 5; 3. Participants have access to mobile devices and the internet; 4. Participants have sufficient audio-visual ability to complete the project; 5. Willing to participate and provide informed consent signed by the participant and at least one parent.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of psychiatric disorders (e.g., depressive disorder, anxiety disorder, bipolar disorder, schizophrenia, eating disorder, OCD); 2. Severe brain/somatic diseases or life-threatening conditions; 3. Currently receiving any antidepressant treatment (medication, physical therapy); 4. Received psychotherapy within the past 6 months; 5. History of substance/drug abuse; 6. Known inability to complete follow-up within 5 months.

Design outcomes

Primary

MeasureTime frame
Change in anxiety symptoms (GAD-7);

Secondary

MeasureTime frame
Change in depression symptoms (PHQ-9);Change in quality of life (PedsQL 4.0);Change in psychological resilience (CD-RISC);Change in stress coping strategies (Brief COPE);Change in cognitive thinking patterns (ITM, SMM & BASS);Change in mental health-related indicators (self-esteem, well-being, loneliness, sleep difficulty, basic psychological needs);Overall satisfaction;Emotion regulation capacity (facial and vocal recognition, eye-tracking, EEG, physiological measures, AI interview, multi-role assessment);Sociodemographic variables (gender, age, ethnicity, parental education level, etc.);

Countries

China

Contacts

Public ContactHu Xiaoyi

Beijing Normal University (Faculty of Education)

huxiaoyi@bnu.edu.cn+86 10 5880 4088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026