NCT05133908

Brief Summary

The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

November 22, 2021

Last Update Submit

February 26, 2022

Conditions

Insomnia

Keywords

Digital interventionCognitive Behavioral Therapy for InsomniaTreatment efficacyTreatment adherence

Outcome Measures

Primary Outcomes (1)

  • Changes in Insomnia Severity Index (ISI)

    Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms

    13 weeks from baseline

Secondary Outcomes (11)

  • Changes in total sleep time (TST)

    13 weeks from baseline

  • Changes in sleep efficiency (SE)

    13 weeks from baseline

  • Changes in sleep onset latency (SOL)

    13 weeks from baseline

  • Changes in midsleep time (MST)

    13 weeks from baseline

  • Changes in fatigue

    13 weeks from baseline

  • +6 more secondary outcomes

Study Arms (2)

Digital Sleep Hygiene and Self-Monitoring Control

ACTIVE COMPARATOR

Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations

Behavioral: Sleep Hygiene and Self-Monitoring Control

dCBTi-ADHD

EXPERIMENTAL

Participants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD

Behavioral: dCBTi-ADHD

Interventions

Sleep Hygiene and Self-Monitoring ControlBEHAVIORAL

An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.

Digital Sleep Hygiene and Self-Monitoring Control
dCBTi-ADHDBEHAVIORAL

The dCBTi adopts a multi-module approach, consisting of 7 weekly modules including psychoeducation on sleep and ADHD, insomnia, organization strategies and distractibility reduction skills, sleep hygiene, sleep restriction and prescription, circadian-related activity scheduling, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep. A virtual coach is also included in the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.

dCBTi-ADHD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (a) Hong Kong resident,
  • (b) Aged between 18-60,
  • (c) Diagnosed with ADHD,
  • (d) Able to read and write Chinese,
  • (e) Has regular access to a smart phone and internet,
  • (f) Insomnia severity index ⩾10

You may not qualify if:

  • (a) Having comorbid bipolar disorder, psychosis, suicidality, moderately severe to severe depression, narcolepsy, and/or hypersomnolence disorder,
  • (b) Having medical conditions that might affect sleep (e.g., serious physical concerns necessitating surgery, risk of falls, epilepsy),
  • (c) Having night shift schedules at work,
  • (d) Currently receiving psychological intervention for insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehavior

Study Officials

  • Wai Sze Chan, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Sze Chan, PhD

CONTACT

(852) 3917 2295chanwais@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All outcome measures will be administered via online surveys
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 22, 2021

First Posted

November 24, 2021

Study Start

February 21, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From after the study findings have been published to 5 years afterwards.
Access Criteria
The request party has a pre-registration of the research that requires data from the present study indicating clearly what data are required and other criteria as the PI deem appropriate.

Locations

HK(1)