This project is based on the biphasic instability model and social timing theory, utilizing IPSRT to help regulate social interactions and establish regular daily habits, alleviate emotional symptoms, and prevent. The included patients with bipolar II disorder who did not take medication for the first time or relapsed within the past month were randomly divided into a medication only group (Q group), a only IPSRT group (I group). Group Q received treatment with quetiapine alone (starting at 50mg/day, with an additional 50mg to 300mg/day per week, and the dosage can be flexibly adjusted); Group I received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting). Compare the changes in various clinical evaluation scales and skin potential before and after treatment, explore the safety and effectiveness of drug therapy and psychotherapy for patients with bipolar II disorder with rhythm disorders, and investigate the potential biological mechanism of IPSRT by collecting data on salivary cortisol and melatonin, peripheral circadian rhythm genes (PER1/PER2/PER3/BMAL1), and magnetic resonance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
Patients received treatment with quetiapine alone (starting at 50mg/day, with an additional 50mg to 300mg/day per week, and the dosage can be flexibly adjusted)
Patients received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting)
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Hamilton Depression Scale (17-items) Total Score Change
The Hamilton Depression Scale (17-items), is a 17 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D17 score indicates more severe depression. A reduction of 50% or more in total score from Baseline indicates clinical response.
Time frame: Baseline，4，8，12 weeks after treatment
Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score
The BRIAN comprises 18 items, which are divided in 3 areas: sleep and social rhythms, activities and eating pattern. The total score ranged from 18 to 72, a higher score suggested a more severe biological rhythm disturbance.
Time frame: Baseline，4，8，12 weeks after treatment
Neuroimaging
MRI
Time frame: Baseline，12 weeks after treatment
Skin potential
In a quiet environment, the subject's left hand was pre connected to a portable skin potential acquisition device to collect skin potential signals under different types of emotional stimulation task paradigms. After denoising, 10 time-domain eigenvalues and 8 time-frequency domain eigenvalues were obtained for each task.
Time frame: Baseline，12 weeks after treatment
Polysomnography
overnight polysomnography
Time frame: Baseline，12 weeks after treatment
Change of the Brief Social Rhythm Scale (BSRS) score
The BSRS assess the irregularity with which participants engage in basic daily activities during the workweek and on the weekend, using a scale ranging from 1 (very regularly) to 6 (very irregularly）
Time frame: Baseline，4，8，12 weeks after treatment
Neuropsychological tests
Software testing (Prisoner's Dilemma game, Social searching task)
Time frame: Baseline，12 weeks after treatment
Change of Beck Scale of Suicidal Ideation score
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week. The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
Time frame: Baseline，4，8，12 weeks after treatment
Change of the Pittsburgh Sleep Quality Index (PSQI) score
The PSQI is a validated self-report questionnaire assessing sleep quality and disturbance over 1 month, quantifying 7 sleep-related domains, with higher scores indicating worse sleep quality.
Time frame: Baseline，4，8，12 weeks after treatment
Change of the Young Mania Rating Scale (YMRS) score
The Young Mania Rating Scale (YMRS) , is a 11 item diagnostic questionnaire used to measure the severity of mania symptom in patients with mood disorders.
Time frame: Baseline，4，8，12 weeks after treatment
Change of Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety.
Time frame: Baseline，4，8，12 weeks after treatment
Change of the Sociaty Adaptive Scale score
SAS is a self-rating scale used to assess an individual's social functioning in areas such as work, study, interpersonal communication, and family life.
Time frame: Baseline，4，8，12 weeks after treatment
blood
Blood samples are collected to analyze the expression levels of peripheral circadian clock genes (PER1/PER2/PER3/BMAL1).
Time frame: Baseline，12 weeks after treatment
saliva samples
Saliva is employed for the analysis of cortisol and melatonin
Time frame: Baseline，12 weeks after treatment
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