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Self-help Smartphone-delivered Cognitive Behavioral Therapy for Insomnia in People With Depression and Insomnia

Primary Purpose

Sleep Initiation and Maintenance Disorders, Depression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Waitlist Control
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychology, The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CBT-I condition

Waitlist control condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 7, 2020
Last Updated
February 14, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04228146
Brief Title
Self-help Smartphone-delivered Cognitive Behavioral Therapy for Insomnia in People With Depression and Insomnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT-I condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control condition
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Intervention Description
Delay access to the self-help CBT-I treatment.
Primary Outcome Measure Information:
Title
Changes over the measurement points in Center for Epidemiologic Studies Depression Scale
Description
Measures the severity of depressive symptoms during the past week. Range from 0 to 60, where a higher value indicates more severe depressive symptoms.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Changes over the measurement points in Insomnia Severity Index
Description
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.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Changes over the measurement points in Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Secondary Outcome Measure Information:
Title
Changes over measurement points in SF-12 Version 1 Physical Scale
Description
Measures subjective physical health status during the past four weeks. A higher value indicates better subjective physical health.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Changes over measurement points in SF-12 Version 1 Mental Scale
Description
Measures subjective physical health status during the past four weeks. A higher value indicates better subjective mental health.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Changes over measurement points in Hospital Anxiety and Depression Scale - Anxiety subscale
Description
Measures severity of anxiety symptoms during the past week. Range from 0 to 21, where a higher value indicates more severe anxiety symptoms.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Other Pre-specified Outcome Measures:
Title
Changes over measurement points in Modified Credibility/Expectancy Questionnaire (Credibility Scores)
Description
Measures participants' perceived treatment credibility. A higher value indicates higher levels of perceived treatment credibility.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Changes over measurement points in Modified Credibility/Expectancy Questionnaire (Expectancy Scores)
Description
Measures participants' perceived treatment expectancy. A higher value indicates higher levels of perceived treatment expectancy.
Time Frame
Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Modified Participant Acceptability/Usability Rating Scale
Description
Measures participants' subjective evaluation of the treatment received via the smartphone application. A higher value indicates higher levels of perceived treatment acceptability.
Time Frame
Post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Title
Demographics
Description
Measures Participants' age, education level, marital status, occupation, and gender
Time Frame
Stage 1 screening (online survey): First day of enrollment
Title
Clinical comorbidity
Description
Measures current diagnosis of four major comorbidities (generalized anxiety disorder, phobias, obsessive compulsive disorder, and panic disorder).
Time Frame
Stage 2 screening (telephone diagnostic interview): Up to 3 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian S Chan, PhD
Phone
+852 39177121
Email
shaunlyn@hku.hk
Facility Information:
Facility Name
Department of Psychology, The University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian S Chan, PhD
Phone
+852 39177121
Email
shaunlyn@hku.hk
First Name & Middle Initial & Last Name & Degree
Christian S Chan, PhD
First Name & Middle Initial & Last Name & Degree
Victoria KY Hui, PhD
First Name & Middle Initial & Last Name & Degree
Christy YF Wong, BS

12. IPD Sharing Statement

Citations:
PubMed Identifier
33036655
Citation
Hui 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.
Results Reference
derived

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Self-help Smartphone-delivered Cognitive Behavioral Therapy for Insomnia in People With Depression and Insomnia

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