dCBTi for Adults With ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Sleep Hygiene and Self-Monitoring Control
* Behavioral: dCBTi-ADHD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital intervention, Cognitive Behavioral Therapy for Insomnia, Treatment efficacy, Treatment adherence