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Completed

NCT Number: NCT05136638

dCBTi With and Without Coaching Support

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

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Key information

Conditions

Insomnia Behavior Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dCBTI

Behavioral

The dCBTi adopts a multi-module approach, consisted of 6 weekly modules including psychoeducational on sleep, insomnia, sleep hygiene, sleep restriction and prescription, stimulus control, relaxation and worry time, cognitive restructuring, and relapse prevention. In each module, participants will watch short videos to learn strategies to improve their sleep.

Virtual Coaching

Behavioral

A virtual coach will be added to the app functionality. It will be in the form of a text-based forced-choice conversation bot. It will initiate conversations with the users to check their understanding of treatment materials and guide them to come up with specific action plans to implement the treatment strategies.

Non-therapist coaching

Behavioral

A research intern will answer questions and address concerns raised by the participant at the end of modules 1, 3, and 6 by phone. The contact time will be within 30 minutes on each occasion.

Therapist coaching

Behavioral

A clinical psychology trainee will provide therapeutic support to enhance the use and adherence to CBTi treatment strategies at the end of modules 1, 3, and 6 by phone. The contact time will be within 30 minutes on each occasion.

Sleep Hygiene and Self-Monitoring Control

Behavioral

An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.

Primary outcomes

  1. Changes in Insomnia Severity Index (ISI)

    Time frame: 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 outcomes

  1. Changes in Sleep Condition Indicator (SCI)

    Time frame: 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

  2. Changes in sleep efficiency

    Time frame: 12 weeks from baseline

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

  3. Changes in sleep onset latency (SOL)

    Time frame: 12 weeks from baseline

    Sleep onset latency (SOL) measured by Consensus Sleep Diary. Its unit is minutes. Longer SOL indicates greater levels of insomnia

  4. Changes in wake after sleep onset

    Time frame: 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

  5. Changes in sleep-related cognitions

    Time frame: 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.

  6. Changes in sleep-related safety behaviors

    Time frame: 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

  7. Changes in daytime sleepiness

    Time frame: 12 weeks from baseline

    Sleepiness measured by the Epworth Sleepiness Scale (ESS). The score ranges from 0 to 24, higher scores indicate greater sleepiness.

  8. Changes in fatigue

    Time frame: 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

  9. Changes in depressive symptoms

    Time frame: 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

  10. Changes in anxiety symptoms

    Time frame: 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

  11. Changes in psychological wellbeing

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2021
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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