Insomnia
Conditions
Keywords
Digital intervention, Cognitive Behavioral Therapy for Insomnia, Treatment efficacy, Treatment adherence
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.
Interventions
BEHAVIORALdCBTi
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.
BEHAVIORALVirtual 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.
BEHAVIORALNon-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.
BEHAVIORALTherapist 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.
An app with self-monitoring function and videos and written materials about sleep hygiene will be provided.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcome measures will be administered via online surveys
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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-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 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 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 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 |
| 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 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 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. |
Countries
Hong Kong
Outcome results
None listed