Clinical trial NCT05136638: dCBTi With and Without Coaching Support
Official title: A Randomized Controlled Comparative Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi): Comparing Efficacy and Adherence to dCBTi With Virtual and Human Coaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2021-11-29
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current research aims to evaluate the adherence and efficacy of dCBTi with different types of coaching support.

Detailed description: Participants will be randomly assigned to one of the five conditions. C1: Sleep Hygiene and Self-Monitoring Control Condition; C2: dCBTi without coaching; C3; dCBTi with virtual coaching; C4: dCBTi with non-therapist coaching; C5: dCBTi with therapist coaching.

Question 1:

Does dCBTi work better than the active control?

Hypothesis 1:

Participants in C2, C3, C4, and C5 will have greater improvement in insomnia than those in C1.

Question 2:

Does coaching support, virtual or human, improve treatment adherence and outcome?

Hypothesis 2:

Participants in C3, C4, and C5 will have greater improvement in insomnia and greater adherence to treatment recommendations than those in C2.

Question 3:

Does human coaching enhance treatment adherence and outcome?

Hypothesis 3:

Participants in C4 and C5 will have greater improvement in primary outcome than those in C3.

Question 4:

Does therapist-coaching-support enhance treatment adherence and outcome to a greater extent than virtual and non-therapist coaching support?

Hypothesis 4:

Participants in C5 will have greater improvement in primary outcome than those in C3 and C4.

Eligibility criteria: Inclusion Criteria:

* (a) Hong Kong resident,
* (b) Aged 18 or above,
* (c) Able to read and write Chinese,
* (d) Has regular access to a smart phone and internet,
* (e) insomnia severity index ⩾10;
* (f) Willing and can be contacted by experimenter via phone between 9 am - 9 pm

Exclusion Criteria:

* (a) significant untreated/unstable mental or medical illness,
* (b) known factor to interfere with participation in this research,
* (c) serious medical, neurological, or psychiatric illness that may affect participation in this research,
* (d) sleep apnea,
* (e) concurrent treatment for insomnia,
* (f) unstablized medication that can affect sleep

Primary outcomes:
measure: Changes in Insomnia Severity Index (ISI)
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Changes in Sleep Condition Indicator (SCI)
timeFrame: 12 weeks from baseline
measure: Changes in sleep efficiency
timeFrame: 12 weeks from baseline
measure: Changes in sleep onset latency (SOL)
timeFrame: 12 weeks from baseline
measure: Changes in wake after sleep onset
timeFrame: 12 weeks from baseline
measure: Changes in sleep-related cognitions
timeFrame: 12 weeks from baseline
measure: Changes in sleep-related safety behaviors
timeFrame: 12 weeks from baseline
measure: Changes in daytime sleepiness
timeFrame: 12 weeks from baseline
measure: Changes in fatigue
timeFrame: 12 weeks from baseline
measure: Changes in depressive symptoms
timeFrame: 12 weeks from baseline
measure: Changes in anxiety symptoms
timeFrame: 12 weeks from baseline
measure: Changes in psychological wellbeing
timeFrame: 12 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: