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

NCT06156306 | Recruiting

• 1 other identifier: 20230914
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Anxiety; Youth

Keywords

Insomnia; Anxiety; Youth

Outcome Measures

Primary Outcomes (3)

• Severity of anxiety symptoms and severity

  General Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms and severity.

  Baseline, Postintervention (6 weeks), and 3-month follow up

• Severity of anxiety symptoms

  Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms.

  Baseline, Postintervention (6 weeks), and 3-month follow up

• Clinician-rated severity of anxiety symptoms

  Hamilton Anxiety Rating Scale (HAM-A) will be used to assess anxiety symptoms.

  Baseline, Postintervention (6 weeks), and 3-month follow up

Secondary Outcomes (13)

• Severity of insomnia symptoms

  Baseline, Postintervention (6 weeks), and 3-month follow up

• Sleep-wake pattern

  Baseline, Postintervention (6 weeks), and 3-month follow up

• Daytime sleepiness

  Baseline, Postintervention (6 weeks), and 3-month follow up

• Anxiety trait

  Baseline, Postintervention (6 weeks), and 3-month follow up

• Severity of depressive symptoms

  Baseline, Postintervention (6 weeks), and 3-month follow up

Study Arms (2)

CBT-I

ACTIVE COMPARATOR

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.

Behavioral: CBT-I

CBT-I combined ACT

EXPERIMENTAL

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.

Behavioral: CBT-I combined ACT

Interventions

CBT-I BEHAVIORAL

The CBT-I intervention will cover sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation training.

CBT-I

CBT-I combined ACT BEHAVIORAL

In addition to the standard CBT-I components, mindfulness, thought diary, and other ACT components will be taught in the group.

CBT-I combined ACT

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, the Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Rachel Ngan Yin Chan, PhD

  Department of Psychiatry, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ngan Yin Chan, PhD

CONTACT

39710550; rachel.chan@cuhk.edu.hk

Julia Wai Han Sun, M.S.Sc

CONTACT

39710550; julia.sun@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 15, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)