Sleep Initiation and Maintenance DisordersNCT04228146
Self-help Smartphone-delivered Cognitive Behavioral Therapy for Insomnia in People With Depression and Insomnia
A study testing Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders and Depression, run by The University of Hong Kong at 1 site in China.
Trial summary
This randomized controlled trial aims to examine the effectiveness of a self-help smartphone-delivered cognitive behavioral therapy for insomnia, compared to a waitlist control, in treating people with major depression and insomnia in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Depression
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2019to Jun 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Stage 1 Screening (Online Survey) Inclusion Criteria:
- Hong Kong residents
- age ≥ 18 years
- predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or non-restorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least three nights per week for at least three months
- Insomnia Severity Index score ≥ 8
- Patient Health Questionnaire (PHQ-9) score ≥ 10
- being able to read Chinese and type Chinese or English
- have a smartphone device (iOS or Android operating system) with Internet access
- have a regular email address
- willing to give informed consent and comply with the trial protocol
Stage 1 Screening (Online Survey) Exclusion Criteria:
- Beck Depression Inventory II (BDI-II) suicidal ideation score ≥ 2
- receiving concurrent psychological treatment at least once per month
- former proACT-S pilot clinical trial participants
- currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, sleeping pills regularly
- carrying a diagnosis of psychosis or schizophrenia
- participating in any other academic studies or clinical trials related to insomnia and/or depression
Stage 2 Screening (Telephone Diagnostic Interview) Inclusion Criteria
- difficulty initiating sleep, maintaining sleep, or early-morning awakening with inability to return to sleep at least once in the past two weeks
- International Statistical Classification of Diseases and Related Health Problems - Tenth Revision diagnosis of depression (F32.00, F32.01, F32.10, F32.11, F32.2)
Stage 2 Screening (Telephone Diagnostic Interview) Exclusion Criteria
- having concurrent psychological treatment at least once per month
- currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, sleeping pills regularly
- carrying a diagnosis of psychosis or schizophrenia
- participating in any other academic studies or clinical trials related to insomnia and/or depression
- having current suicidal plans or acts or have had suicidal plans or acts within the past 12 months
Main Study Trial Withdrawal Criteria
- have concurrent psychological treatment at least once per month
- are taking prescribed psychiatric drugs such as antidepressants, tranquilizers, sleeping pills regularly
- are being diagnosed with psychosis or schizophrenia
- are participating in any other academic studies or clinical trials related to insomnia and/or depression
- have suicidal ideations defined as scoring ≥ 2 on the BDI-II suicidal ideation item
- have experienced serious diseases, significant life events, hospitalization, or fatalities
- withdraw their consent
- do not complete each assessment within two weeks, do not submit consent within two weeks after proACT-S personal account registration, or do not log into proACT-S within two weeks after random group assignment. (waitlist control group) fail the cross-condition contamination check
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Psychology, The University of Hong Kong
Hong Kong
Christian S Chan, PhD, +852 39177121, shaunlyn@hku.hk
Christian S Chan, PhD
About this study
Official title: Parallel Group Randomized Controlled Trial on the Effect of a Smartphone-delivered Cognitive Behavioral Therapy for Insomnia on People With Major Depression and Insomnia
This randomized controlled trial aims to examine the effectiveness of a self-help smartphone-delivered cognitive behavioral therapy for insomnia, compared to a waitlist control, in treating people with major depression and insomnia in Hong Kong.
Read the detailed description
Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This two-arm parallel randomized controlled trial (RCT) aims to examine the effectiveness of a smartphone-based self-help CBT-I with a waitlist control group in treating people with major depression and insomnia in Hong Kong.
Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application known as proACT-S. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow up. The recruitment is underway. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the effectiveness of the CBT-I intervention
Participants in the CBT-I condition will start CBT-I immediately after randomization; while participants in the waitlist control group will start CBT-I (equivalent to that of the CBT-I group) immediately after completing the post-intervention assessment. It is hypothesized that, after the intervention, participants in the CBT-I condition will report a greater decrease in poor sleep quality, depression severity and insomnia severity than those in the waitlist control condition. It is also hypothesized that the reduction in poor sleep quality, depression severity and insomnia severity observed in the CBT-I condition will be maintained at 6-week follow-up. Furthermore, it is hypothesized that participants in the waitlist control condition will report a significant decrease in poor sleep quality, depression severity and insomnia severity after receiving CBT-I.
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Waitlist Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Immediate access to the self-help CBT-I treatment, content of which is based on the translated Chinese version of a well-established CBT-I treatment manual entitled "Insomnia: A Clinician's Guide to Assessment and Treatment". CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia. The self-help CBT-I treatment is delivered in Chinese language in six consecutive weekly modules via a smartphone application known as proACT-S. Duration of each module is around 45 to 60 minutes.
Waitlist ControlOther
Delay access to the self-help CBT-I treatment.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I condition | Experimental | Participants in the CBT-I condition start the 6-week CBT-I immediately after randomization, complete the post-intervention assessment right after they finish the treatment, and complete the follow-up assessment six weeks after the post-intervention assessment. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Waitlist control condition | Other | Participants in the waitlist control group complete the post-intervention assessment six weeks after the baseline assessment, start CBT-I (equivalent to that of the CBT-I group) immediately after completing the post-intervention assessment, and complete the follow-up assessment right after they finish the 6-week CBT-I. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes over the measurement points in Center for Epidemiologic Studies Depression Scale
Measures the severity of depressive symptoms during the past week. Range from 0 to 60, where a higher value indicates more severe depressive symptoms.
Measured: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Changes over the measurement points in Insomnia Severity Index
Measures the severity of insomnia symptoms and the associated daytime impairment over the past two weeks. Range from 0 to 21, where a higher value indicates more severe insomnia symptoms.
Measured: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Changes over the measurement points in Pittsburgh Sleep Quality Index
Measures sleep quality and disturbances during the past month. It has seven components, namely, sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of hypnotics, and daytime dysfunction. Range from 0 to 21, where a higher value indicates poorer sleep quality.
Measured: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Secondary outcomes (3)
Changes over measurement points in SF-12 Version 1 Physical Scale
Measures subjective physical health status during the past four weeks. A higher value indicates better subjective physical health.
Measured: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Changes over measurement points in SF-12 Version 1 Mental Scale
Measures subjective physical health status during the past four weeks. A higher value indicates better subjective mental health.
Measured: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Changes over measurement points in Hospital Anxiety and Depression Scale - Anxiety subscale
Measures severity of anxiety symptoms during the past week. Range from 0 to 21, where a higher value indicates more severe anxiety symptoms.
Measured: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start19 Mar 2019
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian S. Chan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228146
- Sponsor's protocol ID
- EA1810026
- Status last verified
- Feb 2020
- First submitted
- 7 Jan 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan CS, Wong CYF, Yu BYM, Hui VKY, Ho FYY, Cuijpers P. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial. Psychol Med. 2023 Apr;53(5):1799-1813. doi: 10.1017/S0033291721003421. Epub 2021 Aug 23.
PubMed 37310329Hui VK, Wong CY, Ma EK, Ho FY, Chan CS. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial. Trials. 2020 Oct 9;21(1):843. doi: 10.1186/s13063-020-04778-1.
PubMed 33036655
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group Randomized Controlled Trial on the Effect of a Smartphone-delivered Cognitive Behavioral Therapy for Insomnia on People With Major Depression and Insomnia
- ClinicalTrials.gov ID
- NCT04228146
- Acronym / sponsor ID
- EA1810026
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to examine the effectiveness of a self-help smartphone-delivered cognitive behavioral therapy for insomnia, compared to a waitlist control, in treating people with major depression and insomnia in Hong Kong.
Detailed description
Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This two-arm parallel randomized controlled trial (RCT) aims to examine the effectiveness of a smartphone-based self-help CBT-I with a waitlist control group in treating people with major depression and insomnia in Hong Kong.
Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application known as proACT-S. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow up. The recruitment is underway. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the effectiveness of the CBT-I intervention
Participants in the CBT-I condition will start CBT-I immediately after randomization; while participants in the waitlist control group will start CBT-I (equivalent to that of the CBT-I group) immediately after completing the post-intervention assessment. It is hypothesized that, after the intervention, participants in the CBT-I condition will report a greater decrease in poor sleep quality, depression severity and insomnia severity than those in the waitlist control condition. It is also hypothesized that the reduction in poor sleep quality, depression severity and insomnia severity observed in the CBT-I condition will be maintained at 6-week follow-up. Furthermore, it is hypothesized that participants in the waitlist control condition will report a significant decrease in poor sleep quality, depression severity and insomnia severity after receiving CBT-I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I condition | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaParticipants in the CBT-I condition start the 6-week CBT-I immediately after randomization, complete the post-intervention assessment right after they finish the treatment, and complete the follow-up assessment six weeks after the post-intervention assessment. |
| Waitlist control condition | Other | Other: Waitlist ControlParticipants in the waitlist control group complete the post-intervention assessment six weeks after the baseline assessment, start CBT-I (equivalent to that of the CBT-I group) immediately after completing the post-intervention assessment, and complete the follow-up assessment right after they finish the 6-week CBT-I. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaImmediate access to the self-help CBT-I treatment, content of which is based on the translated Chinese version of a well-established CBT-I treatment manual entitled "Insomnia: A Clinician's Guide to Assessment and Treatment". CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia. The self-help CBT-I treatment is delivered in Chinese language in six consecutive weekly modules via a smartphone application known as proACT-S. Duration of each module is around 45 to 60 minutes. | Behavioural | CBT-I condition |
| Waitlist ControlDelay access to the self-help CBT-I treatment. | Other | Waitlist control condition |
Primary outcome
Changes over the measurement points in Center for Epidemiologic Studies Depression Scale
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Measures the severity of depressive symptoms during the past week. Range from 0 to 60, where a higher value indicates more severe depressive symptoms.
Changes over the measurement points in Insomnia Severity Index
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Measures the severity of insomnia symptoms and the associated daytime impairment over the past two weeks. Range from 0 to 21, where a higher value indicates more severe insomnia symptoms.
Changes over the measurement points in Pittsburgh Sleep Quality Index
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Measures sleep quality and disturbances during the past month. It has seven components, namely, sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of hypnotics, and daytime dysfunction. Range from 0 to 21, where a higher value indicates poorer sleep quality.
3 secondary outcomes
Changes over measurement points in SF-12 Version 1 Physical Scale
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Changes over measurement points in SF-12 Version 1 Mental Scale
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Changes over measurement points in Hospital Anxiety and Depression Scale - Anxiety subscale
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 37310329Chan CS, Wong CYF, Yu BYM, Hui VKY, Ho FYY, Cuijpers P. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: a parallel-group randomized controlled trial. Psychol Med. 2023 Apr;53(5):1799-1813. doi: 10.1017/S0033291721003421. Epub 2021 Aug 23.
- Derived from this study: PubMed 33036655Hui VK, Wong CY, Ma EK, Ho FY, Chan CS. Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial. Trials. 2020 Oct 9;21(1):843. doi: 10.1186/s13063-020-04778-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders and Depression, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian S Chan, PhD (+852 39177121, shaunlyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes over the measurement points in Center for Epidemiologic Studies Depression Scale (time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up). The study lists 3 primary outcomes in all. 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 NCT04228146, which also lists 2 linked publications.
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 18 Feb 2020.