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dCBTi With and Without Coaching Support

Not Applicable
Completed
Conditions
Insomnia
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.

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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Changes in sleep-related cognitions12 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 fatigue12 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 efficiency12 weeks from baseline

Sleep efficiency measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep

Changes in anxiety symptoms12 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 onset12 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 wellbeing12 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 behaviors12 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 sleepiness12 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 symptoms12 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

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

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