dCBTi for Adults With ADHD

Overview

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.

Full Title of Study: “A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) for Adults With Attention Deficit Hyperactivity Disorder (ADHD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • Behavioral: Sleep Hygiene and Self-Monitoring Control
    • An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
  • 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.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Insomnia Severity Index (ISI)
    • Time Frame: 13 weeks from baseline
    • Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms

Secondary Measures

  • Changes in total sleep time (TST)
    • Time Frame: 13 weeks from baseline
    • Total sleep time (TST) measured by Consensus Sleep Diary. Its units is minutes. Higher TST indicates longer total sleep duration.
  • Changes in sleep efficiency (SE)
    • Time Frame: 13 weeks from baseline
    • Sleep efficiency (SE) measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep
  • Changes in sleep onset latency (SOL)
    • Time Frame: 13 weeks from baseline
    • Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia
  • Changes in midsleep time (MST)
    • Time Frame: 13 weeks from baseline
    • Midsleep time (MST) measured by Consensus Sleep Diary. Its unit is time. Earlier MST indicates earlier overall timing of sleep.
  • Changes in fatigue
    • Time Frame: 13 weeks from baseline
    • Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue
  • Changes in depressive symptoms
    • Time Frame: 13 weeks from baseline
    • Depressive symptoms measured by the Patient Health Questionnaire – 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed
  • Changes in anxiety symptoms
    • Time Frame: 13 weeks from baseline
    • 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
  • Changes in mental wellbeing
    • Time Frame: 13 weeks from baseline
    • 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
  • Changes in ADHD symptoms
    • Time Frame: 13 weeks from baseline
    • ADHD symptoms measured by the Adult ADHD Self-Report Scale (ASRS). The score ranges from 0 to 72, the higher the greater symptom severity
  • Changes in functional impairment due to ADHD symptoms
    • Time Frame: 13 weeks from baseline
    • 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
  • Changes in executive skills
    • Time Frame: 13 weeks from baseline
    • Executive skills measured by the Executive Skills Questionnaire-Revised (ESQ-R). The score ranges from 0 to 75, the lower the stronger executive skills

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Chan Wai Sze, Assistant Professor – The University of Hong Kong
  • Overall Official(s)
    • Wai Sze Chan, PhD, Principal Investigator, The University of Hong Kong
  • Overall Contact(s)
    • Wai Sze Chan, PhD, (852) 3917 2295, chanwais@hku.hk

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