dCBTi With and Without Coaching Support

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: dCBTi; Behavioral: Sleep Hygiene and Self-Monitoring Control; Behavioral: Virtual coaching; Behavioral: Therapist coaching; Behavioral: Non-therapist coaching

• Registration Number: NCT05136638
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-29
• Study Start: 2021-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dCBTi with virtual coaching	dCBTi	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.
dCBTi with non-therapist coaching support	dCBTi	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.
Digital Sleep Hygiene and Self-Monitoring Control	Sleep Hygiene and Self-Monitoring Control	Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
dCBTi without coaching	dCBTi	Participants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support
dCBTi with virtual coaching	Virtual coaching	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.
dCBTi with therapist coaching support	Therapist coaching	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.
dCBTi with non-therapist coaching support	Virtual coaching	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.
dCBTi with non-therapist coaching support	Non-therapist coaching	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.
dCBTi with therapist coaching support	dCBTi	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.
dCBTi with therapist coaching support	Virtual coaching	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.

Primary Outcome Measures

Name	Time	Method
Changes in Insomnia Severity Index (ISI)	12 weeks from baseline	Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms

Secondary Outcome Measures

Name	Time	Method
Changes in sleep-related cognitions	12 weeks from baseline	Sleep-related cognitions measured by the Dysfunctional Beliefs and Attitudes about Sleep 16-item Scale (DBAS-16). Respondents rate their agreement to each of the 16 statements on a Visual Analog Scale (0-100). Higher scores indicate more dysfunctional sleep-related cognitions.
Changes in Sleep Condition Indicator (SCI)	12 weeks from baseline	Insomnia symptoms measured by the Sleep Condition Indicator (SCI). The score ranges from 0 to 32. Higher scores indicate lower levels of insomnia symptoms
Changes in sleep onset latency (SOL)	12 weeks from baseline	Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia
Changes in fatigue	12 weeks from baseline	Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue
Changes in sleep efficiency	12 weeks from baseline	Sleep efficiency measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep
Changes in anxiety symptoms	12 weeks from baseline	Anxiety symptoms measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7). The score ranges from 0 to 21, the higher the more anxious
Changes in wake after sleep onset	12 weeks from baseline	Wake after sleep onset (WASO) measured by Consensus Sleep Diary. Its unit is minutes. Longer WASO indicates greater levels of insomnia
Changes in psychological wellbeing	12 weeks from baseline	Psychological wellbeing measured by the Satisfaction with Life Scale (SWLS). The score ranges from 5 to 35, the higher indicates greater wellbeing
Changes in sleep-related safety behaviors	12 weeks from baseline	Sleep-related safety behaviors measured by the Sleep-Related Behavior Questionnaire - 20 (SRBQ-20). The score ranges from 0 to 80, higher scores indicate greater engagement in sleep-related safety behaviors
Changes in daytime sleepiness	12 weeks from baseline	Sleepiness measured by the Epworth Sleepiness Scale (ESS). The score ranges from 0 to 24, higher scores indicate greater sleepiness.
Changes in depressive symptoms	12 weeks from baseline	Depressive symptoms measured by the Patient Health Questionnaire - 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong