dCBTi for Adults With ADHD

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133908
• Other study ID #: EA210505
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: The University of Hong Kong
• Contact: Wai Sze Chan, PhD
• Phone: (852) 3917 2295
• Email: chanwais[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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