Effectiveness of Group Cognitive Behavioral Therapy for Psychological Sub-health (EGCBTPS)

Jiangsu Province Nanjing Brain Hospital

Status: Enrolling

Conditions: Mental Suffering

Treatments: Behavioral: Group Cognitive Behavioral Therapy (GCBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05913349

81725005-7

Details and patient eligibility

About

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.

Full description

This study is a double-blind randomized controlled trial designed to assess the efficacy of GCBT compared to a waiting group for mental sub-health. Participants will be randomly (1:1) assigned to the GCBT group and the waiting group. All participants will receive 4 sessions (1 session per week) of 90 minutes each for 4 weeks.The GCBT group will receive cognitive behavioral therapy at the 1st-4th weeks, while the waiting group will receive cognitive behavioral therapy at the 5th-8th weeks. Before GCBT (baseline) and after GCBT (4th weeks, 8th weeks, 28th weeks), both groups will be assessed for clinical symptoms; during the 4 weeks of the intervention, we will collect sensor data and daily diary feedback. The GCBT is mainly divided into four stages, and each stage has a topic. The topic of each stage as follow:# understanding depression, anxiety, and CBT;# understanding automatic thinking and negative automatic thinking;# identifying and correcting negative automatic thinking identification; identifying and correcting intermediate beliefs;#understanding core beliefs and mastering correction techniques.The purposes of the present study are to: 1) evaluate the clinical response the GCBT in mental sub-health. 2) further understand the possible biological mechanism underlying the efficacy of GCBT by analyzing digital biomarkers.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

A total of > 5 on PHQ-9 or a total of > 5 on GAD-7

Exclusion criteria

Acute suicidal thoughts, With a severe or potentially confounding psychiatric disorder (e.g. psychosis, substance misuse).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

The clinical response of the group cognitive behavioural therapy

Experimental group

Description:

A randomized controlled study of GCBT with one-month and six-month post-treatment follow-up was conducted to explore the short- and long-term efficacy of GCBT on mental sub-health

Treatment:

Behavioral: Group Cognitive Behavioral Therapy (GCBT)

The alterations of behavior and physiological features in the group cognitive behavioral therapy.

Experimental group

Description:

To understand the possible biological mechanism underlying the efficacy of group cognitive behavioral therapy by analyzing alterations of the alterations of behaviors and Physiological features in the group cognitive behavioral therapy features.

Treatment:

Behavioral: Group Cognitive Behavioral Therapy (GCBT)