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

NCT06967922 | Recruiting

• 1 other identifier: ICBT for AID
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Insomnia Disorder

Keywords

Acute insomnia disorder; Analytic-Integrative Cognitive Behavioural Therapy; stress

Outcome Measures

Primary Outcomes (1)

• The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.

  The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

  Baseline, 6 weeks

Secondary Outcomes (4)

• The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

Study Arms (2)

Acceptance analysis - integrated cognitive behavioral therapy

EXPERIMENTAL

Behavioral: Analytic-Integrative Cognitive Behavioural Therapy

Receive sleep hygiene education

ACTIVE COMPARATOR

Other: Sleep hygiene education

Interventions

Analytic-Integrative Cognitive Behavioural Therapy 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.

Acceptance analysis - integrated cognitive behavioral therapy

Sleep hygiene education 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.

Receive sleep hygiene education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)