NCT05133908

dCBTi for Adults With ADHD

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-21
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-11-24
• Last updated: 2022-03-14

Locations

1 site across 1 country: Hong Kong