dCBTi for Adults With ADHD

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Insomnia

Treatments: Behavioral: dCBTi-ADHD; Behavioral: Sleep Hygiene and Self-Monitoring Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05133908

EA210505

Details and patient eligibility

About

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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Digital Sleep Hygiene and Self-Monitoring Control

Active Comparator group

Description:

Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations

Treatment:

Behavioral: Sleep Hygiene and Self-Monitoring Control

dCBTi-ADHD

Experimental group

Description:

Participants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD

Treatment:

Behavioral: dCBTi-ADHD