Clinical trial NCT06967922: Impact of Analytic-integrative Cognitive Behavioural Therapy on Acute Insomnia Disorder (Stress)
Official title: Evaluation of Analytic-integrative Cognitive Behavioural Therapy for Acute Insomnia Disorder (Stress)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Insomnia Disorder
Keywords: Acute insomnia disorder
Analytic-Integrative Cognitive Behavioural Therapy
stress
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study, conducted in a population with acute insomnia disorder (stress), was to investigate the efficacy of Analytic-Integrative Cognitive Behavioural Therapy in the treatment of acute insomnia disorder (stress).

Detailed description: Acute insomnia disorder, also known as short-term insomnia disorder, is basically characterised by difficulties with short-term sleep onset and maintenance and results in feelings of sleep dissatisfaction. When insomnia arises in response to a stressful life event (painful loss of a loved one, major illness, or divorce), associated features may include anxiety, worry, sadness, or depression related to the specific stressor. Medications are a common form of treatment for acute insomnia disorders, and while they may improve the patient's clinical symptoms, the overall results are not very satisfactory. Cognitive behavioural therapy, as a non-pharmacological treatment, has become the first-line recommended solution in the insomnia treatment guidelines of China and the United States, which can correct patients' wrong sleep cognition and bad sleep habits, establish correct sleep-wake cognition, and also improve mental health. Compared with sedative-hypnotic medications, it has no adverse reactions and does not affect daytime function, making it a green and safe treatment method. Based on the exact efficacy of cognitive behavioural therapy in improving insomnia, and also considering the diverse causes of acute insomnia disorder (stress), we analyse-integrate the analysis of the patient's specific situation, and we propose to treat acute insomnia disorder through analytical-integrative cognitive behavioural therapy, formulate an individualized treatment plan to improve the therapeutic effect, and prevent the patient from developing in the direction of chronic insomnia.

Eligibility criteria: Inclusion Criteria:

1. meeting the DSM-5 diagnostic criteria for insomnia disorder;
2. a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI);
3. age ≥18 years old, with junior high school education or above;
4. voluntarily participating in this study and signing an informed consent form;
5. the diagnostic criteria for acute insomnia disorder (duration of the disease less than 3 months).

Exclusion Criteria:

1. people with comorbid serious physical or severe mental illnesses, suicide risk;
2. clinically diagnosed or suspected sleep breathing disorder, restless legs syndrome and sleep-wake rhythm disorder, shift workers;
3. pregnant and breastfeeding women;
4. people who are currently undergoing any psychological treatment.

Primary outcomes:
measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: