Clinical trial NCT05133908: dCBTi for Adults With ADHD
Official title: A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Digital intervention
Cognitive Behavioral Therapy for Insomnia
Treatment efficacy
Treatment adherence
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Insomnia Severity Index (ISI)
timeFrame: 13 weeks from baseline
Secondary outcomes:
measure: Changes in total sleep time (TST)
timeFrame: 13 weeks from baseline
measure: Changes in sleep efficiency (SE)
timeFrame: 13 weeks from baseline
measure: Changes in sleep onset latency (SOL)
timeFrame: 13 weeks from baseline
measure: Changes in midsleep time (MST)
timeFrame: 13 weeks from baseline
measure: Changes in fatigue
timeFrame: 13 weeks from baseline
measure: Changes in depressive symptoms
timeFrame: 13 weeks from baseline
measure: Changes in anxiety symptoms
timeFrame: 13 weeks from baseline
measure: Changes in mental wellbeing
timeFrame: 13 weeks from baseline
measure: Changes in ADHD symptoms
timeFrame: 13 weeks from baseline
measure: Changes in functional impairment due to ADHD symptoms
timeFrame: 13 weeks from baseline
measure: Changes in executive skills
timeFrame: 13 weeks from baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Wai Sze Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: