NCT04228146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

January 7, 2020

Last Update Submit

February 14, 2020

Conditions

Sleep Initiation and Maintenance DisordersDepression

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up

  • Changes over measurement points in SF-12 Version 1 Mental Scale

    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

    Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up

Other Outcomes (5)

  • Changes over measurement points in Modified Credibility/Expectancy Questionnaire (Credibility Scores)

    Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up

  • Changes over measurement points in Modified Credibility/Expectancy Questionnaire (Expectancy Scores)

    Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up

  • Modified Participant Acceptability/Usability Rating Scale

    Post-intervention: 6 weeks after CBT-I initiation, 6-week follow up

  • +2 more other outcomes

Study Arms (2)

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.

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.

Other: Waitlist Control

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

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.

CBT-I condition
Waitlist ControlOTHER

Delay access to the self-help CBT-I treatment.

Waitlist control condition

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, The University of Hong Kong

Hong Kong, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37310329DERIVED

  • 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.

    PMID: 33036655DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Christian S Chan, PhD

CONTACT

+852 39177121shaunlyn@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 14, 2020

Study Start

March 19, 2019

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

CN(1)