An interventional study of Cognitive Behavioral Therapy for Insomnia and Waitlist Control in Sleep Initiation and Maintenance Disorders and Depression, sponsored by The University of Hong Kong. Status unknown at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 285 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Stage 1 Screening (Online Survey) Inclusion Criteria:
Stage 1 Screening (Online Survey) Exclusion Criteria:
Stage 2 Screening (Telephone Diagnostic Interview) Inclusion Criteria
Stage 2 Screening (Telephone Diagnostic Interview) Exclusion Criteria
Main Study Trial Withdrawal Criteria
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
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
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.
Delay access to the self-help CBT-I treatment.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
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.
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
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
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.
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
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.
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
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.
Time frame: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
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.
Time frame: Post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
Demographics
Measures Participants' age, education level, marital status, occupation, and gender
Time frame: Stage 1 screening (online survey): First day of enrollment
Clinical comorbidity
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
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
The University of Hong Kong