Comparison of the Effects of Support and Non-support Online CBT-I

NCT05011929 | Unknown

• 1 other identifier: EA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Change of insomnia symptoms

  Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.

  Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups

Secondary Outcomes (14)

• Change of sleep quality

  Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups

• Change of sleep diary measure (total time in bed)

  Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups

• Change of sleep diary measure (total sleep time)

  Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups

• Change of sleep diary measure (sleep efficiency)

  Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups

• Change of sleep diary measure (sleep onset latency)

  Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups

Study Arms (2)

online CBT-I with support (individualized feedback and reminders)

EXPERIMENTAL

The mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week.

Behavioral: Cognitive behavioral therapy

online CBT-I without support

ACTIVE COMPARATOR

same as the experimental arm but without reminders and individualized feedback

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

refer to the arm description

online CBT-I with support (individualized feedback and reminders); online CBT-I without support

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Chinese aged 12-24 years old;
• Informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
• Being able to comply with the study protocol;
• Having a DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) \>= 9 (suggested cut-off for adolescents)

You may not qualify if:

• A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
• Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
• Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
• Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
• In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
• Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
• Initiation of or change in antidepressant medication within past 2 months;
• Having been or is currently receiving any structured psychotherapy;
• With hearing or speech deficit;
• Night shift worker.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shirley Xin Li, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Xin Li, PhD

CONTACT

852 39177035; shirley.li@hku.hk

Study Design

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

Model Details: A randomised, assessor-blind, parallel group controlled trial

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: August 18, 2021
• Study Start: December 10, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)