Impact of Analytic-integrative Cognitive Behavioural Therapy on Acute Insomnia Disorder (Stress)

NCT ID: NCT06967922

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

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.

Conditions

Acute Insomnia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acceptance analysis - integrated cognitive behavioral therapy

Group Type: EXPERIMENTAL

Analytic-Integrative Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

Analytic-Integrative Cognitive-Behavioural Approach: Initial Interview for Information Gathering: comprehensive collection of patient information; Assessment: collection of multidimensional factors; Diagnosis: insomnia and co-morbidities; Analytic-Integrative Analysis for Treatment Decision Making.

Receive sleep hygiene education

Group Type: ACTIVE_COMPARATOR

Sleep hygiene education

Intervention Type: OTHER

Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.

Interventions

Analytic-Integrative Cognitive Behavioural Therapy

Analytic-Integrative Cognitive-Behavioural Approach: Initial Interview for Information Gathering: comprehensive collection of patient information; Assessment: collection of multidimensional factors; Diagnosis: insomnia and co-morbidities; Analytic-Integrative Analysis for Treatment Decision Making.

Intervention Type: BEHAVIORAL

Sleep hygiene education

Participants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Facility Contacts

Role: primary

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Other Identifiers

ICBT for AID

Identifier Type: -

Identifier Source: org_study_id