dCBTi With and Without Coaching Support

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136638
• Other study ID #: EA210458
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	Changes in sleep efficiency	Sleep efficiency measured by Consensus Sleep Diary. It ranges from 0 to 100%, the higher indicates better sleep	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	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.	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	Changes in daytime sleepiness	Sleepiness measured by the Epworth Sleepiness Scale (ESS). The score ranges from 0 to 24, higher scores indicate greater sleepiness.	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	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	12 weeks from baseline
Secondary	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	12 weeks from baseline