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Recruiting NCT06967922

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

No phase Interventional Acute Insomnia Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Analytic-Integrative Cognitive Behavioural Therapy, Sleep hygiene education.
Who it may be relevant to
Registry conditions: Acute Insomnia Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Analytic-integrative Cognitive Behavioural Therapy for Acute Insomnia Disorder (Stress)

Overview

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.

Interventions

  • Behavioral 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.
  • Other 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.

Primary outcome measures

  • The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks. [Time frame: Baseline, 6 weeks]
Secondary outcome measures (4)
  • The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06967922 · ICBT for AID

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗