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Effectiveness of Group Cognitive Behavioral Therapy for Psychological Sub-health

NCT05913349 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-22

No results posted yet for this study

Summary

Mental health has become an increasing concern, especially since the beginning of the COVID-19 pandemic. However, not all individuals in mental suboptimal states require pharmacological treatment. Cognitive Behavioral Therapy（CBT） can achieve its therapeutic effect by improving activation patterns of the brain's internal networks to promote self-regulation.

The study was designed as a randomized clinical trial with two groups, the GCBT group and the Waiting group, in a state of mental subluxation. the GCBT group received both self-help therapy and on-site guidance, while the Waiting group received the GCBT intervention after treatment in the GCBT group. Data collection was conducted by trained, certified and qualified personnel.

The study was designed to use assessment wearable devices (WD) and mobile apps (MA) for behavioral data and EMA collection during treatment, and the extracted behavioral characteristics were used as objective indicators for long-term and short-term efficacy assessment of GCBT, further understand the possible biological mechanism underlying the efficacy of GCBT by analyzing digital biomarkers.

Conditions

  • Mental Suffering

Interventions

BEHAVIORAL

Group Cognitive Behavioral Therapy (GCBT)

Group cognitive behavioral therapy can achieve its therapeutic effect by enhancing emotion regulation and cognitive control, and by improving the activation patterns of the brain's internal networks to promote self-regulation. This can help individuals better manage emotional fluctuations in daily life, resulting in further improvement of depressive and anxious symptoms.

Sponsors & Collaborators

  • Jiangsu Province Nanjing Brain Hospital

    lead OTHER

Principal Investigators

  • Fei Wang Study Chair, PHD · Affiliated Nanjing Brain Hospital, Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2023-09-01
Completion
2024-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05913349 on ClinicalTrials.gov