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Assessing the Impact of Digital Cognitive Behavioural Therapy for Insomnia on Depression Symptoms and Processes in Young Adults.

Assessing the Impact of Digital Cognitive Behavioural Therapy for Insomnia on Depression Symptoms and Processes in Young Adults.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001291673
Enrollment
79
Registered
2023-12-12
Start date
2024-03-06
Completion date
2029-02-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Depression and insomnia are important and related public health problems for young people. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTI). CBTI programs are known to effectively reduce symptoms of depression without directly targeting non-sleep symptoms. However, the mechanisms which underlie the association between insomnia and depression are not well understood. Many candidate mechanisms have been proposed (e.g., cognitive biases), yet, there is a lack of research which investigates these possible mechanisms, and data from treatment studies is greatly needed to investigate the causal role of these mechanisms in the association between insomnia and depression. This randomised controlled trial aims to investigate what psychological mechanisms explain how digital cognitive behavioural therapy for insomnia improves depression in young people. It is hypothesised that the group who receive the brief CBTI program will display greater improvement in symptoms of depression and insomnia, and a greater change in mechanisms thought to underlie the association between depression and insomnia symptoms, compared to the group that receive education (waitlist control).

Interventions

Digital Cognitive Behavioural Therapy for Insomnia (Digital CBTI). Rationale: Digital CBTI (i.e., CBTI delivered in a digital format) is a well validated treatment for Insomnia. CBTI programs are known to effectively reduce symptoms of depression without directly targeting non-sleep symptoms. However, the mechanisms which underlie the association between improvement in insomnia and improvements in depression are not well understood. Many candidate mechanisms have been proposed (e.g., cognitive

Digital Cognitive Behavioural Therapy for Insomnia (Digital CBTI). Rationale: Digital CBTI (i.e., CBTI delivered in a digital format) is a well validated treatment for Insomnia. CBTI programs are known to effectively reduce symptoms of depression without directly targeting non-sleep symptoms. However, the mechanisms which underlie the association between improvement in insomnia and improvements in depression are not well understood. Many candidate mechanisms have been proposed (e.g., cognitive biases), yet, there is a lack of research which investigates these possible mechanisms, and data from treatment studies is greatly needed to investigate the causal role of these mechanisms in the association between insomnia and depression. Type: Non-drug, online, interactive Setting/location: Online, any location in Australia Duration: 5 x 20 minute online sessions, delivered over 5 consecutive weeks Protocol: This program is based on CBTI, the recommended treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). It is based on a digitised version of a brief CBTI protocol described in a scientific article in the Australian Journal of General Practice (Sweetman et al., 2021, AJGP, doi: 10.31128/AJGP-04-20-5391). Content: Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Participants will be asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants will receive tailored therapy recommendations (e.g., prescribed time in bed) during each weekly session, determined by an in-built algorithm and participants' entered data (see Sweetman et al., 2021, Aus J General Practice for tailored therapy recommendations). Immediately after each session is completed, participants will receive an automated follow-up email with session-specific 'follow-up' information and tailored therapy recommendations including recommended bedtime window (approximate reading time: 15 minutes). Participants will receive another automated email one week later with a link to start each subsequent session. Videos are presented by researchers, psychologists, and sleep technicians, each with extensive experience (>8 years) in the management of insomnia. Tailoring / personalisation: Therapy recommendations will be tailored to participant's insomnia symptoms at baseline and weekly changes in symptoms throughout the program. Bedtime Restriction Therapy (initial restriction of time in bed to consolidate sleep, and subsequent gradual extension of time in bed) is a core component of CBTI. Bedtime restriction recommendations will be tailored to the specific sleep/wake information that participants provide. Primary therapeutic components: Psychoeducation about sleep, Bedtime restriction therapy, Stimulus Control Therapy, Relaxation Therapy, Cognitive Refocusing, Relapse Prevention. Adherence assessment: Adherence will be defined as the number of participants commencing each of the 5 online sessions. This information is automatically collected through the online system.

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

Young adults aged 18 – 24 years. PHQ-9 score of 10 or above (i.e., moderate depression symptoms) Reliable access to computer, tablet or smartphone, with internet access Basic English language comprehension as required for digital CBTI program

Exclusion criteria

Psychiatric condition (Bipolar disorder, schizophrenia) Epilepsy Currently pregnant Moderate daytime sleepiness (Epworth Sleepiness Scale score equal to or more than 16) People who are commercial drivers or operate heavy machinery for work People with a cognitive impairment Shift workers Previous diagnosis of a narcolepsy or REM sleep disorder Previous sleepiness-related motor-vehicle accident Acute Suicidality (active suicidality, or elevated risk as determined by clinical judgement) In all cases where individuals are excluded from the study, an appropriate onward referral will be made.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026