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Two talking therapies for young people with insomnia and anxiety

Compares two talking therapies for anxiety in young people with insomnia.

Key facts

Who runs it
Chinese University of Hong Kong
Where
Shatin, Hong KongSee the site
Trial code
Registry title
CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety
Status
Recruiting
People taking part
50 people, planned
Started
15 Dec 2023
Planned end
31 Dec 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CBT-I
  • CBT-I combined ACT
Record updated
10 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for Chinese young people aged 15-24 years who have both sleep problems (insomnia) and anxiety. It compares two group talking therapies.

Age
15-24 years
Sex
All sexes can join.
Disease stage
Insomnia with a score above the cut-off of 9 on the insomnia severity index (ISI), and anxiety with a score at the cut-off of 10 on the GAD-7 questionnaire.
Earlier treatment
People currently having psychological treatment or medicine for insomnia or anxiety disorder cannot join.

Main reasons for not taking part

  • A diagnosis of psychosis, schizophrenia, bipolar disorder or intellectual disability.
  • Another diagnosed sleep disorder, such as delayed sleep phase or narcolepsy.
  • Serious suicidal thoughts with a plan, or a suicide attempt.
  • Current psychological or medicine treatment for insomnia or anxiety disorder.
  • Not able to listen, speak and read Chinese and Cantonese, or no smartphone.

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Youth who meet the following criteria would be eligible for taking part in this trial:
  • Chinese youth aged 15-24 years old, ii. Presence of insomnia problems as defined by insomnia severity index (ISI) using cut-off of 9, which has been locally validated cut off for detecting clinical insomnia), iii. Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 10 for detecting clinical anxiety, iv. Ability to listen, speak, and read Chinese and Cantonese, and v. Written informed consent of participation into the study is given by youth and his/her parent's if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi. Possession of smartphone

Who cannot take part

  • A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability ii. Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP) iii. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID) iv. Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder
  • A youth would be excluded from the study if meeting one or more of the following criteria:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 24 years old?

Where in Hong Kong

  • Department of Psychiatry, the Chinese University of Hong KongShatin, Hong KongContact: Rachel Ngan Yin Chan, PhDTaking people

About the trial

What the trial wants to find out

Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and/or mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.

The 2 groups in the trial

  • CBT-IExisting treatment, for comparison

    A total of 6 sessions of face-to-face group CBT-I therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects.

  • CBT-I combined ACTTreatment being tested

    A total of 6 sessions of face-to-face group CBT-I+ACT therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effectiveness of CBT-I and CBT-I Combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial
Plain-language title
Two talking therapies for young people with insomnia and anxietyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06156306, who can take part
Record updated
10 July 2025