Actively Recruiting

Phase Not Applicable
Age: 15Years - 24Years
All Genders
ID06156306

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

Led by Chinese University of Hong Kong · Updated on 2025-07-10

50

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two types of therapy—cognitive-behavioral therapy for insomnia (CBT-I) alone and CBT-I combined with acceptance and commitment therapy (ACT)—to improve anxiety symptoms in young people aged 15 to 24 who have insomnia and anxiety. Insomnia is common among adolescents and youth and often occurs alongside anxiety, affecting about 30% of individuals. The study addresses the shared neurological and cognitive factors that contribute to both sleep difficulties and anxiety, focusing on improving treatment by targeting both conditions together. Participants will receive six sessions of face-to-face group therapy lasting 90 to 120 minutes each, with groups of 8 to 10 youths. One group will receive only CBT-I, which includes sleep education, stimulus control, sleep restriction, cognitive therapy, and relaxation training. The other group will receive CBT-I plus ACT components such as mindfulness and thought diaries. Both approaches aim to improve sleep and reduce anxiety symptoms. During the study, researchers will assess anxiety severity at the start, after the 6-week intervention, and again at a 3-month follow-up. They will also monitor insomnia symptoms, sleep patterns, daytime sleepiness, mood, sleep beliefs, psychological flexibility, arousal levels, rumination, stress events, life satisfaction, and overall well-being using questionnaires and clinical interviews. The total duration includes initial screening, treatment sessions, and follow-up assessments to evaluate the lasting effects of the therapies.

CONDITIONS

Brief Title

CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety

Who Can Participate

Age: 15Years - 24Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chinese youth aged 15 to 24 years old
  • Presence of insomnia symptoms as defined by a locally validated Insomnia Severity Index cut-off of 9
  • Presence of anxiety symptoms as defined by General Anxiety Disorder-7 cut-off of 10
  • Ability to listen, speak, and read Chinese and Cantonese
  • Written informed consent given by participant and parent if under 18 years old; individual assent also obtained if under 18
  • Possession of a smartphone
Not Eligible

You will not qualify if you...

  • Clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability
  • Diagnosed sleep disorder such as delayed sleep phase or narcolepsy contributing to disrupted sleep
  • Presence of clinically significant suicidality with plan or attempt
  • Currently receiving psychological or pharmacological treatment for insomnia or anxiety disorder

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 6 weeks

Participants receive 6 face-to-face group therapy sessions of either CBT-I or CBT-I combined with ACT for insomnia and anxiety symptoms.

6 weekly sessions (in-person)

Follow-up

Duration - 3 months

Participants are monitored to assess the lasting effects of the therapy on anxiety and insomnia symptoms.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Department of Psychiatry, the Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Actively Recruiting

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Research Team

R

Rachel Ngan Yin Chan, PhD

J

Julia Wai Han Sun, M.S.Sc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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