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

Official title

Prevent Worsening of Depressive Symptoms Using Digital Cognitive Behavioral Therapy for Insomnia and Circadian Intervention in College Students

Overview

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.

Detailed description

The current study is a three-arm randomized controlled trial. Guided by a trained sleep therapist, all participants will receive 6-week education content delivered via a mobile application and 6 brief phone call follow-ups. They will be re-assessed at post intervention, and 6-month after intervention to evaluate the efficacy and sustainability of the therapist-guided digital insomnia and circadian intervention.

Interventions

• Behavioral digital cognitive behavioral therapy for insomnia and digital circadian intervention
  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 intervie
• Behavioral digital cognitive behavioral therapy for insomnia
  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.
• Other digital health education
  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.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Changes of Patient Health Questionnaire 9-item (PHQ-9) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of Hospital Anxiety and Depression Scale (HADS) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of Incidence of major depression disorders at follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of The Connor-Davidson Resilience Scale - 10 item (CDRS-10) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of Insomnia Severity Index (ISI) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of 7-day actigraphy and app-based sleep diary outcomes between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of Munich chronotype questionnaire (MCTQ) and morningness-eveningness questionnaire (MEQ) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of The Traditional Chinese self-report version of Biological Rhythms Interview for Assessment in Neuropsychiatry between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of Pittsburgh Sleep Quality Index (PSQI) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of The Epworth Sleepiness Scale (ESS) between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of EuroQol 5-Dimension 5-Level Questionnaire between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]
• Changes of Smartphone-based multimodal measurement between baseline and follow ups [Time frame: baseline, 1-week post-intervention follow-up, and 6-month post-intervention follow-up]

Eligibility criteria

Inclusion criteria

• 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.
• Accessibility to a smartphone.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07677930 · 2024.692

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗