Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol...

Area of Science:

• Mental Health
• Digital Therapeutics
• Sleep Medicine

Background:

• Major depression and insomnia are significant public health issues.
• Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective but faces accessibility challenges.
• Smartphone-based CBT-I offers a potential solution to overcome traditional treatment barriers.

Purpose of the Study:

• To evaluate the efficacy of a self-help smartphone-based CBT-I (proACT-S) for individuals with major depression and insomnia.
• To compare the smartphone CBT-I intervention against a waitlist control group.
• To assess changes in sleep quality, insomnia severity, and depression severity.

Main Methods:

• A two-arm parallel randomized controlled trial involving 285 Hong Kong Chinese adults (aged 17+) with major depression and insomnia.
• Participants were randomized 1:1 to receive immediate smartphone CBT-I (proACT-S) or a waitlist control.
• Primary outcomes included changes in sleep quality, insomnia severity, and depression severity, measured at baseline, post-intervention, and 6-week follow-up.

Main Results:

• The study protocol was designed to examine the efficacy of the proACT-S intervention.
• Recruitment for the trial has been completed.
• Analysis will utilize multilevel linear mixed models based on the intention-to-treat principle.

Conclusions:

• Smartphone-based CBT-I (proACT-S) is expected to be an effective brief, self-help treatment for comorbid depression and insomnia.
• If proven effective, proACT-S could serve as a community-based early intervention.
• This approach may help reduce the burden on public healthcare systems.