Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students

Sponsor
Chinese University of Hong Kong
Study ID
NCT07677930
Status
Not Yet Recruiting

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Conditions

  • Circadian Rhythm
  • Depressed Mood
  • Eveningness
  • Insomnia

Eligibility Criteria

Sex
ALL
Age
18 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • digital cognitive behavioral therapy for insomnia and digital circadian intervention — BEHAVIORAL
    For the combined dCBT-I + dCI program, additional circadian intervention will be included to support entrainment of the biological clock. These components include circadian education, strategies to gradually advance circadian phase, advice on morning sunlight exposure, and components of social rhythm therapy to establish a consistent daily sleep routine (e.g., consistent meal times and exercise). The digital intervention will be implemented through a therapist-guided using motivational interviewing approach. Participants will be motivated to advance their sleep schedule by following fixed daytime activities using motivational interviewing techniques to support their autonomy and self-efficacy in making behavioral changes
  • digital cognitive behavioral therapy for insomnia — BEHAVIORAL
    Digital CBT-I has been developed by our group based on a well-established framework that includes sleep education, behavioral strategies such as stimulus control and sleep restriction, constructive worry strategies, cognitive restructuring, relaxation training and sleep hygiene education. For the dCBT-I alone group, therapists will primarily review participants' sleep schedule, setting sleep restriction window, and problem-solving efforts.
  • digital health education — OTHER
    Participants in the control group will be app-based general health education with an equivalent dosage as the two intervention groups. To control for therapist contact time, the health education control group will also receive brief telephone follow-up sessions that focus solely on reviewing the content of the educational modules, without incorporating any active sleep-related intervention strategies.

Study Details

Depression is a leading cause of global disease burden, poor quality of life, disability and suicide, and commonly occurs in adolescence and early adulthood. Insomnia and circadian factors were regarded as potential targets for preventing worsening of depressive symptoms. Additionally, digital insomnia treatment reduces depressive symptoms but is insufficient for individuals with an evening chronotype. Circadian intervention is an adjunctive treatment for sleep disturbance and depression, but is often overlooked. In this study, we aim to evaluate the effect of guided digital insomnia and circadian intervention (dCBT-I + dCI) in reducing depressive symptoms in college students with insomnia and an evening chronotype compared with digital insomnia intervention alone (dCBT-I) and a health education group (dHE). We also aim to develop and evaluate multimodal prediction models to identify individuals who are more or less likely to respond to the interventions, using clinical, behavioral, circadian, and digital engagement data.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
195 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: dCBT-I + dCI group
    Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia and digital circadian intervention.
  • Active Comparator: dCBT-I group
    Potential subjects will receive therapist-guided digital cognitive behavioral therapy for insomnia.
  • Active Comparator: d-HE group
    Potential subjects will receive digital health education.

Primary Outcome Measure

Changes of Hamilton Rating Scale for Depression (HRSD) between baseline and follow ups [ Time Frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up ]

Central Contacts

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