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NCT Number: NCT06967922

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

  1. 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 BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.

  2. 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 BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.

  3. 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 SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.

  4. 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

    The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxing Wang, MD & PhD

CONTACT

[email protected]

+86 13911127385

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.