dCBTi With and Without Coaching Support

The University of Hong Kong (HKU)

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Therapist coaching; Behavioral: Virtual coaching; Behavioral: Sleep Hygiene and Self-Monitoring Control; Behavioral: dCBTi; Behavioral: Non-therapist coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT05136638

EA210458

Details and patient eligibility

About

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

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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129 participants in 5 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 without coaching

Experimental group

Description:

Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support

Treatment:

Behavioral: dCBTi

dCBTi with virtual coaching

Experimental group

Description:

Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with a virtual coach in the form of a text-based force-choice conversation coach. The virtual coach will check participants' understanding of the treatment materials and lead them to come up with action plans to implement CBTi strategies.

Treatment:

Behavioral: dCBTi

Behavioral: Virtual coaching

dCBTi with non-therapist coaching support

Experimental group

Description:

Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with the virtual coach. They will get additional support from a non-therapist support person who provides support after modules 1, 3, and 6 to address any questions or concerns.

Treatment:

Behavioral: Non-therapist coaching

Behavioral: dCBTi

Behavioral: Virtual coaching

dCBTi with therapist coaching support

Experimental group

Description:

Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with the virtual coach. They will get additional support from a clinical psychology trainee who provides therapeutic support that aims to enhance the usage of CBTi treatment strategies.

Treatment:

Behavioral: Therapist coaching

Behavioral: dCBTi

Behavioral: Virtual coaching