Comparing CBT-I and CBT-I with ACT for Youth Insomnia and Anxiety

Effectiveness of CBT-I and CBT-I Combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial

Not applicable Interventional Chinese University of Hong Kong · NCT06156306

This study is testing whether combining cognitive-behavioral therapy for insomnia with acceptance and commitment therapy can help young people aged 15-24 sleep better and feel less anxious compared to just using cognitive-behavioral therapy alone.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment50 (estimated)
Ages15 Years to 24 Years
SexAll
SponsorChinese University of Hong Kong Academic / other
Locations1 site (Shatin, New Territories)
Trial IDNCT06156306 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of cognitive-behavioral therapy for insomnia (CBT-I) alone versus CBT-I combined with acceptance and commitment therapy (ACT) in improving anxiety symptoms among youth aged 15-24. Given the high prevalence of insomnia and its comorbidity with anxiety in adolescents, the study will recruit participants who meet specific criteria related to insomnia severity and anxiety levels. The interventions will be delivered to assess their impact on both sleep and anxiety, with the hypothesis that the combined approach will yield better outcomes. The study is conducted at the Chinese University of Hong Kong, focusing on a population that speaks Chinese and Cantonese.

Who should consider this trial

Good fit: Ideal candidates are Chinese youth aged 15-24 who experience insomnia and anxiety symptoms.

Not a fit: Patients with clinical diagnoses of psychosis, schizophrenia, bipolar disorders, or intellectual disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for youth suffering from insomnia and anxiety.

How similar studies have performed: Previous studies have shown effectiveness for both CBT-I and ACT in treating insomnia, but direct comparisons of these approaches in youth are limited.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

Youth who meet the following criteria would be eligible for taking part in this trial:

i. 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

Exclusion Criteria:

A youth would be excluded from the study if meeting one or more of the following criteria:

i. 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.

Where this trial is running

Shatin, New Territories

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions InsomniaAnxietyYouth
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.