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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228146
• Other study ID #: EA1810026
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: June 2021

Study information

• Verified date: February 2020
• Source: The University of Hong Kong
• Contact: Christian S Chan, PhD
• Phone: +852 39177121
• Email: shaunlyn[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.

Other:
• Waitlist Control
Delay access to the self-help CBT-I treatment.

Locations

Country	Name	City	State
China	Department of Psychology, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes over measurement points in Modified Credibility/Expectancy Questionnaire (Credibility Scores)	Measures participants' perceived treatment credibility. A higher value indicates higher levels of perceived treatment credibility.	Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Other	Changes over measurement points in Modified Credibility/Expectancy Questionnaire (Expectancy Scores)	Measures participants' perceived treatment expectancy. A higher value indicates higher levels of perceived treatment expectancy.	Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Other	Modified Participant Acceptability/Usability Rating Scale	Measures participants' subjective evaluation of the treatment received via the smartphone application. A higher value indicates higher levels of perceived treatment acceptability.	Post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Other	Demographics	Measures Participants' age, education level, marital status, occupation, and gender	Stage 1 screening (online survey): First day of enrollment
Other	Clinical comorbidity	Measures current diagnosis of four major comorbidities (generalized anxiety disorder, phobias, obsessive compulsive disorder, and panic disorder).	Stage 2 screening (telephone diagnostic interview): Up to 3 months after enrollment
Primary	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
Primary	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
Primary	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	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.	Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Secondary	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.	Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Secondary	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.	Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up