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

NCT ID: NCT04228146

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2021-06-30

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.

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT-I condition

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

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 control condition

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.

Group Type: OTHER

Waitlist Control

Intervention Type: OTHER

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

Interventions

Cognitive Behavioral Therapy for Insomnia

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: BEHAVIORAL

Waitlist Control

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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)

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christian S. Chan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Psychology, The University of Hong Kong

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Christian S Chan, PhD

Role: CONTACT

shaunlyn@hku.hk

+852 39177121

Facility Contacts

Christian S Chan, PhD

Role: primary

shaunlyn@hku.hk

+852 39177121

References

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.

Reference Type: DERIVED

PMID: 37310329 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33036655 (View on PubMed)

Other Identifiers

EA1810026

Identifier Type: -

Identifier Source: org_study_id