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InsomniaNCT05136638

dCBTi With and Without Coaching Support

A study testing dCBTi, Virtual coaching and Non-therapist coaching in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current research aims to evaluate the adherence and efficacy of dCBTi with different types of coaching support. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Insomnia
What is being tested?
dCBTi, Virtual coaching and Non-therapist coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteHong Kong
Study dates
1 Dec 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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

Who cannot join

  • (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 locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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

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

Read the 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.

Conditions
Insomnia
Being tested
dCBTi, Virtual coaching, Non-therapist coaching, Therapist coaching, Sleep Hygiene and Self-Monitoring Control
Keywords
Digital intervention, Cognitive Behavioral Therapy for Insomnia, Treatment efficacy, Treatment adherence
Medical subject headings
Sleep Initiation and Maintenance Disorders, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dCBTiBehavioural

    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 coachingBehavioural

    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 coachingBehavioural

    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 coachingBehavioural

    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 ControlBehavioural

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

Study groups in NCT05136638
Study groupRoleWhat they receive
Digital Sleep Hygiene and Self-Monitoring ControlActive comparatorParticipants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
Receives: Behavioral: Sleep Hygiene and Self-Monitoring Control
dCBTi without coachingExperimentalParticipants assigned to this condition will receive a 6-module digital cognitive behavioral therapy for insomnia (dCBTi) with no coaching support
Receives: Behavioral: dCBTi
dCBTi with virtual coachingExperimentalParticipants 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.
Receives: Behavioral: dCBTi; Behavioral: Virtual coaching
dCBTi with non-therapist coaching supportExperimentalParticipants 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.
Receives: Behavioral: dCBTi; Behavioral: Virtual coaching; Behavioral: Non-therapist coaching
dCBTi with therapist coaching supportExperimentalParticipants 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.
Receives: Behavioral: dCBTi; Behavioral: Virtual coaching; Behavioral: Therapist coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Insomnia Severity Index (ISI)

    Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms

    Measured: 12 weeks from baseline

Secondary outcomes (11)

  1. Changes in Sleep Condition Indicator (SCI)

    Insomnia symptoms measured by the Sleep Condition Indicator (SCI). The score ranges from 0 to 32. Higher scores indicate lower levels of insomnia symptoms

    Measured: 12 weeks from baseline

  2. Changes in sleep efficiency

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

    Measured: 12 weeks from baseline

  3. Changes in sleep onset latency (SOL)

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

    Measured: 12 weeks from baseline

  4. Changes in wake after sleep onset

    Wake after sleep onset (WASO) measured by Consensus Sleep Diary. Its unit is minutes. Longer WASO indicates greater levels of insomnia

    Measured: 12 weeks from baseline

  5. Changes in sleep-related cognitions

    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.

    Measured: 12 weeks from baseline

  6. Changes in sleep-related safety behaviors

    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

    Measured: 12 weeks from baseline

  7. Changes in daytime sleepiness

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

    Measured: 12 weeks from baseline

  8. Changes in fatigue

    Fatigue measured by the Fatigue Assessment Scale (FAS). The score ranges from 10 to 50, the higher the greater levels of fatigue

    Measured: 12 weeks from baseline

  9. Changes in depressive symptoms

    Depressive symptoms measured by the Patient Health Questionnaire - 9 (PHQ-9). The score ranges from 0 to 27, the higher the more depressed

    Measured: 12 weeks from baseline

  10. Changes in anxiety symptoms

    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

    Measured: 12 weeks from baseline

  11. Changes in psychological wellbeing

    Psychological wellbeing measured by the Satisfaction with Life Scale (SWLS). The score ranges from 5 to 35, the higher indicates greater wellbeing

    Measured: 12 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136638
Sponsor's protocol ID
EA210458
Status last verified
Aug 2023
First submitted
3 Nov 2021
Last updated
9 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data will be made available for sharing with other researchers for secondary analysis upon request.

Publications

  • Chan WS, Cheng WY, Lok SHC, Cheah AKM, Lee AKW, Ng ASY, Kowatsch T. Assessing the Short-Term Efficacy of Digital Cognitive Behavioral Therapy for Insomnia With Different Types of Coaching: Randomized Controlled Comparative Trial. JMIR Ment Health. 2024 Aug 7;11:e51716. doi: 10.2196/51716.

    PubMed 39110971

Questions about this trial

What is this clinical trial studying?

A study testing dCBTi, Virtual coaching and Non-therapist coaching in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Insomnia Severity Index (ISI) (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05136638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.

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