dCBTi for Adults With ADHD

A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep Hygiene and Self-Monitoring Control; Behavioral: dCBTi-ADHD

Detailed Description

Participants would be randomly assigned to the experimental or sleep diary self-monitoring (control) group. Participants in the experimental group would use a digital application for seven weeks, whereas participants in the control group would watch psychoeducation videos on sleep hygiene and enter sleep diary measures using the application for seven weeks.

Question 1:

Does dCBTi work better than the active control?

Hypothesis 1:

Improvement in insomnia (immediately after treatment and at 1-month follow-up) would be greater for the experimental group than the active control group.

Question 2:

Does improvement in insomnia due to dCBTi lead to improvement in ADHD outcomes?

Hypothesis 2:

Improvement in ADHD outcomes would be greater for the experimental group than the active control group. The effect of dCBTi on ADHD outcomes would be mediated by improvement in insomnia.

Question 3:

Does improvement in insomnia due to dCBTi lead to improvement in mental well-being?

Hypothesis 3:

Improvement in outcomes related to mental well-being would be greater for the experimental group than the active control group. The effect of dCBTi on outcomes related to mental well-being would be mediated by improvement in insomnia.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital Sleep Hygiene and Self-Monitoring Control; Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations	Behavioral: Sleep Hygiene and Self-Monitoring Control; An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
Experimental: dCBTi-ADHD; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in total sleep time (TST)	Total sleep time (TST) measured by Consensus Sleep Diary. Its units is minutes. Higher TST indicates longer total sleep duration.	13 weeks from baseline
Changes in sleep efficiency (SE)	Sleep efficiency (SE) measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep	13 weeks from baseline
Changes in sleep onset latency (SOL)	Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia	13 weeks from baseline
Changes in midsleep time (MST)	Midsleep time (MST) measured by Consensus Sleep Diary. Its unit is time. Earlier MST indicates earlier overall timing of sleep.	13 weeks from baseline
Changes in fatigue	Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue	13 weeks from baseline
Changes in depressive symptoms	Depressive symptoms measured by the Patient Health Questionnaire - 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed	13 weeks from baseline
Changes in anxiety symptoms	Anxiety symptoms measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7). The score ranges from 0 to 21, the higher the more anxious	13 weeks from baseline
Changes in mental wellbeing	Mental well-being measured by the Warwick Edinburgh Mental Well-being Scale (WEMWBS). The score ranges from 14 to 70, the higher the greater level of mental well-being	13 weeks from baseline
Changes in ADHD symptoms	ADHD symptoms measured by the Adult ADHD Self-Report Scale (ASRS). The score ranges from 0 to 72, the higher the greater symptom severity	13 weeks from baseline
Changes in functional impairment due to ADHD symptoms	Functional impairment due to ADHD symptoms measured by three questions evaluating the extent to which individuals' ADHD symptoms affect their ability to function in the domains of work/study, housekeeping, and social relationships. The questions are rated on a 4-point scale, with higher ratings indicating higher level of impairment	13 weeks from baseline
Changes in executive skills	Executive skills measured by the Executive Skills Questionnaire-Revised (ESQ-R). The score ranges from 0 to 75, the lower the stronger executive skills	13 weeks from baseline

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Treatment efficacy; Digital intervention; Cognitive Behavioral Therapy for Insomnia; Treatment adherence
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: EA210505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.
• IPD Sharing Time Frame: From after the study findings have been published to 5 years afterwards.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No