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

ConditionsEveningness Insomnia Circadian Rhythm Depressed Mood

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-24

SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Youths aged between 18-24 years old.

Insomnia disorders as determined by DSM-5 criteria with a predominant complaint of difficulty initiating sleep.

Presence of an evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a late bedtime of 12:00 am/midnight or later for at least 3 nights per week in the last 3 months.

Presented with at least subclinical depressive symptoms as determined by Patient Health Questionnaire-9 ≥ 10.

Disqualifiers

Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality other than insomnia and delayed sleep phase syndrome, as ascertained by Structured Diagnostic Interview for Sleep patterns and Disorders (DISP), such as restless leg syndrome and OSA, and narcolepsy.

Diagnosed with neuropsychiatric disorders such as major depressive disorder, anxiety disorders, bipolar affective disorders, schizophrenia, moderate or above suicidality.

Concurrent, regular use of medications known to affect sleep continuity and quality, including both Western medications (e.g. hypnotics, steroids, antidepressants, antihistamines) and over-the-counter medications (e.g. melatonin).

Participate in other psychotherapy (e.g., CBT, mindfulness) currently or in the past three months.

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

195 Participants

are divided into 3 treatment groups

Group A: dCBT-I + dCI groupExperimental treatment 1 intervention

Group B: dCBT-I groupActive comparator 1 intervention

Group C: d-HE groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Changes of Hamilton Rating Scale for Depression (HRSD) between baseline and follow ups

A 17-item clinician-administered instrument to assess depressive symptomatology. It will be rated by an independent assessor blinded to the randomization status.

Time frame