dCBTi for Adults With ADHD

Not Applicable

• Conditions: Insomnia
• Interventions: Behavioral: Sleep Hygiene and Self-Monitoring Control; Behavioral: dCBTi-ADHD

• Registration Number: NCT05133908
• Lead Sponsor: The University of Hong Kong

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-11-24
• Status Verified: 2022-02
• Study Start: 2022-02-21
• Last Update Submitted: 2022-02-26
• Last Update Posted: 2022-03-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Sleep Hygiene and Self-Monitoring Control	Sleep Hygiene and Self-Monitoring Control	Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
dCBTi-ADHD	dCBTi-ADHD	Participants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD

Primary Outcome Measures

Name	Time	Method
Changes in Insomnia Severity Index (ISI)	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 Outcome Measures

Name	Time	Method
Changes in total sleep time (TST)	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)	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)	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)	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	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	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	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	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	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	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	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

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong