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

June 13, 2023 updated by: Jiangsu Province Nanjing Brain Hospital

Effectiveness of Group Cognitive Behavioral Therapy for Psychological Sub-health: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Affiliated Nanjing Brain Hospital, Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The clinical response of the group cognitive behavioural therapy
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)
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.
Experimental: The alterations of behavior and physiological features in the group cognitive behavioral therapy.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline, 4th weeks, 8th weeks and 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.
Time Frame: Baseline, 4th weeks, 8th weeks and 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.
Time Frame: Baseline, 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.
Time Frame: Baseline, 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.
Time Frame: Baseline, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from PPG, ACC, heart rate, blood oxygen, sleep time, RRI, step during intervention
Time Frame: During the treatment period
The sensor data collection time period from 7am to 9pm
During the treatment period
Change from daily mood and energy during intervention
Time Frame: At 7am and 9pm daily during the treatment period
Mood and energy are assessed by a single item each, "On a scale of 1 (very happy) to 7 (very sad), how is your mood right now?" "On a scale of 1 (very tired) to 7 (energetic), how is your energy right now?"
At 7am and 9pm daily during the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Nanjing Brain Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 81725005-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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