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A telehealth cognitive behavioural therapy program for insomnia in Vietnamese-speaking cancer survivors

A single-arm feasibility study of a telehealth-based cognitive behavioural therapy program for insomnia in Vietnamese-speaking cancer survivors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000635662
Enrollment
5
Registered
2023-06-13
Start date
2025-03-01
Completion date
2025-11-09
Last updated
2026-01-12

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

Conditions

None listed

Brief summary

This study aims to evaluate a telehealth cognitive behavioural therapy intervention for insomnia (CBT-I) in Vietnamese-speaking cancer survivors, delivered by a Vietnamese-speaking psychologist. Who is it for? You may be eligible for this study if you are aged 18 years or over and can speak and read Vietnamese, and have completed or are undergoing treatment for cancer, and are now experiencing clinically significant insomnia symptoms. Study details Participants will undergo a six-session CBT-I intervention delivered weekly over telehealth. Upon completion of the intervention, participants will be asked to complete a few questionnaires regarding acceptability of the treatment and changes in their insomnia. It is hoped that this study will help provide evidence for CBT-I delivered for a Vietnamese population and help address inequalities in accessing evidence-based health care for people from Vietnamese-speaking backgrounds.

Interventions

This project aims to evaluate the feasibility and potential efficacy of a manualised Cognitive Behavioural Therapy for Insomnia (CBT-I) intervention for Vietnamese-speaking head and neck cancer survivors delivered via telehealth. CBT-I is an evidence-based intervention that is considered the gold standard treatment for insomnia. The intervention consists of six weekly 1-hr sessions based on existing CBT-I treatment protocols and adapted for delivery in Vietnamese. The key goal for CBT-I is to c

This project aims to evaluate the feasibility and potential efficacy of a manualised Cognitive Behavioural Therapy for Insomnia (CBT-I) intervention for Vietnamese-speaking head and neck cancer survivors delivered via telehealth. CBT-I is an evidence-based intervention that is considered the gold standard treatment for insomnia. The intervention consists of six weekly 1-hr sessions based on existing CBT-I treatment protocols and adapted for delivery in Vietnamese. The key goal for CBT-I is to change dysfunctional sleep habits and thinking patterns that contribute to sleep difficulties, with sessions involving a combination of education about sleep, behavioural interventions, and cognitive interventions. The session outline is as follows: • Session 1: Education about sleep • Session 2: Sleep restriction (involves reducing the overall time an individual spends in bed, with the aim of increasing the percentage of time spent asleep while in bed), and stimulus control (involves retraining the brain to associate the bed/bedroom with being asleep instead of being awake) • Session 3: Sleep hygiene (involves learning helpful habits for sleep), and education about sleep medications • Sessions 4 and 5: Cognitive restructuring (involves identifying and learning tools to manage dysfunctional thoughts that contribute to insomnia) • Session 6: Relapse prevention (involves learning strategies to reduce the severity and likelihood of a relapse occurring) CBT-I MATERIALS To accompany the treatment manual, participants will be provided with an existing CBT resource developed by the Clinical Psychology team at Peter MacCallum Cancer Centre, titled “Can-Sleep: Making Night Time Sleep Problems Go Away”. This resource is a 27-page colour printed booklet, which was developed based on CBT-I protocols and includes information about sleep and strategies to help improve sleep as listed above. This resource is currently used in routine clinical practice at Peter Mac and has undergone translation to Vietnamese. The translation was completed by an accredited translation service. Where there are gaps in the Can-Sleep resource, participants will be provided with additional materials to support the topics covered in the session outline above. These materials are versions of CBT-I handouts used in routine clinical practice, and may include: • A sleep diary and/or sleep journal, to assist participants with tracking their sleep habits • Information about dysfunctional thinking patterns that may contribute to sleep difficulties These handouts have undergone translation to Vietnamese following Peter Mac’s translation guidelines. Additional materials may be developed as required, which will be submitted to HREC for approval prior to translation and delivery to participants. FIDELITY Each session recording and transcription will be assigned a unique session identifier. Transcriptions for a random selection of 25% of sessions will be checked against the recordings for accuracy and then translated to English. The English transcriptions will then be assessed by an objective rater. The rater will score the fidelity to the intervention based on a standardised scoring framework. Adaptations made to sessions will also be recorded.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

- At least 18 years old; - Able to speak and read Vietnamese, and prefer to receive an intervention in Vietnamese - OR are undergoing treatment and medically stable; - Clinically significant insomnia symptoms as indicated by a score of mild or above on the PROMIS Sleep Disturbance measure; - Low risk of sleep disorders not amenable to CBT-I (e.g., restless legs syndrome as assessed by the Restless Legs Screening Tool, and obstructive sleep apnoea as assessed by the STOP-BANG); - With a life expectancy of greater than 6 months as determined by the medical team; - Has access to a device capable of using video-conferencing software

Exclusion criteria

- Has major communication difficulties; - Has a psychiatric or neurological disorder that could impact study participation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026