Effectiveness of Group Cognitive Behavioral Therapy for Psychological Sub-health

NCT05913349 | Unknown

• 1 other identifier: 81725005-7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mental sub-health; Group Cognitive Behavioral Therapy (GCBT); wearable devices; EMA

Outcome Measures

Primary Outcomes (5)

• Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at 4th weeks, 8th weeks, 28th weeks.

  The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.

  Baseline, 4th weeks, 8th weeks and 28th weeks

• Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at 4th weeks, 8th weeks, 28th weeks.

  The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.

  Baseline, 4th weeks, 8th weeks and 28th weeks

• Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at 4th weeks, 8th weeks and 28th weeks.

  The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.

  Baseline, 4th weeks, 8th weeks and 28th weeks

• Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at 4th weeks, 8th weeks and 28th weeks.

  The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).

  Baseline, 4th weeks, 8th weeks and 28th weeks

• Change from baseline in suicidal ideation assessed by the Beck Scale for Suicide (BSS-14; range: 0-38) at 4th weeks, 8th weeks and 28th weeks.

  The total scores of these questionnaires were interpreted as follows: no or low suicidal ideation (0-8), moderate suicidal ideation(9-16), high suicidal ideation (17-38).

  Baseline, 4th weeks, 8th weeks and 28th weeks

Secondary Outcomes (2)

• Change from PPG, ACC, heart rate, blood oxygen, sleep time, RRI, step during intervention

  During the treatment period

• Change from daily mood and energy during intervention

  At 7am and 9pm daily during the treatment period

Study Arms (2)

The clinical response of the group cognitive behavioural therapy

EXPERIMENTAL

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

Behavioral: Group Cognitive Behavioral Therapy (GCBT)

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

EXPERIMENTAL

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.

Behavioral: Group Cognitive Behavioral Therapy (GCBT)

Interventions

Group Cognitive Behavioral Therapy (GCBT) BEHAVIORAL

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.

The alterations of behavior and physiological features in the group cognitive behavioral therapy.; The clinical response of the group cognitive behavioural therapy

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Affiliated Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (2)

• Wang Y, Zhou K, Lin Z, Shen H, Liu R, Su Z, Womer FY, Wang Y, Wei Y, Zhu R, Zheng J, Zhang X, Wang F. Evaluation of the efficacy of group cognitive behavioral therapy on anxiety in college students based on wearable devices and mobile applications: a randomized controlled trial. BMC Psychiatry. 2025 Nov 29;26(1):6. doi: 10.1186/s12888-025-07572-y.

  PMID: 41318529 DERIVED

• Lin Z, Zheng J, Wang Y, Su Z, Zhu R, Liu R, Wei Y, Zhang X, Wang F. Prediction of the efficacy of group cognitive behavioral therapy using heart rate variability based smart wearable devices: a randomized controlled study. BMC Psychiatry. 2024 Mar 6;24(1):187. doi: 10.1186/s12888-024-05638-x.

  PMID: 38448895 DERIVED

Study Officials

• Fei Wang Study Chair, PHD

  Affiliated Nanjing Brain Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Yang Wang, PHD

CONTACT

02418851071224; yangwang201224@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: September 20, 2021
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)