Clinical trial NCT05913349: Effectiveness of Group Cognitive Behavioral Therapy for Psychological Sub-health
Official title: Effectiveness of Group Cognitive Behavioral Therapy for Psychological Sub-health: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Suffering
Keywords: mental sub-health
Group Cognitive Behavioral Therapy (GCBT)
wearable devices
EMA
Lead sponsor: Jiangsu Province Nanjing Brain Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: Baseline, 4th weeks, 8th weeks and 28th weeks
measure: 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.
timeFrame: Baseline, 4th weeks, 8th weeks and 28th weeks
measure: Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at 4th weeks, 8th weeks and 28th weeks.
timeFrame: Baseline, 4th weeks, 8th weeks and 28th weeks
measure: 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.
timeFrame: Baseline, 4th weeks, 8th weeks and 28th weeks
measure: 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.
timeFrame: Baseline, 4th weeks, 8th weeks and 28th weeks
Secondary outcomes:
measure: Change from PPG, ACC, heart rate, blood oxygen, sleep time, RRI, step during intervention
timeFrame: During the treatment period
measure: Change from daily mood and energy during intervention
timeFrame: At 7am and 9pm daily during the treatment period
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Nanjing Brain Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Affiliated Nanjing Brain Hospital, Nanjing Medical University
name: Fei Wang Study Chair, PHD
role: STUDY_CHAIR
References: