None listed
Conditions
Brief summary
Traumatic brain injury (TBI) has been recognised as a major public health issue by the World Health Organisation. Children are particularly susceptible. Children with TBI are at risk of life-long residual cognitive and behavioural deficits. Therefore, development of treatments that promote recovery and improve outcomes is of critical importance. Our initial outcome study showed that 62% of children who sustain moderate to severe TBI experienced sleep disturbance. This is an important finding as sleep is vital for brain development, cognitive, and emotional health. At present, however, sleep disturbances remain largely undiagnosed and untreated after childhood TBI. Development and implementation of effective treatments for sleep disturbances is important, as improved sleep will promote recovery, brain development, cognitive and emotional health, and the wellbeing of children and families. Aims: This study aims to (i) determine the feasibility of CBT for insomnia (CBT-I) following child traumatic brain injury and (ii) determine the efficacy of CBT-I on sleep and secondary functional gains in fatigue, pain, behaviour/mood, and cognition. Participants: Seven children (age 11-16 years) who meet the following criteria will be recruited: (i) receiving outpatient treatment for TBI at the Brain Injury Rehabilitation Program, Sydney Children's Hospital Randwick; (ii) subclinical to clinical symptoms of insomnia (i.e., T-score >55) on the Sleep Disturbance Scale for Children or evidence of reduced sleep quality on actigraphy. In addition, a structured clinical interview will be conducted to evaluate children's sleep against the International Classification of Sleep Disorders (ICSD), 2nd Edition; and (iii) participant and family fluent in English. Baseline assessment: Participants will be randomised to 7- or 14-day baseline assessment of sleep (i.e., wear an actigraphy watch and complete a daily sleep diary) and questionnaires about sleep, fatigue, pain, behaviour/mood, and cognition. Intervention: All participants will then complete 4 x 75min weekly sessions of individual manualised CBT-I treatment during which time they will continue to wear an actigraphy watch and complete the daily sleep diary for the duration of the 4 weeks. Therapists delivering the intervention will rate participants' treatment engagement using a questionnaire after each treatment session. Post-intervention assessment: Following treatment, all participants will complete 7-day assessment of sleep (actigraphy and sleep diary) and questionnaires. They will also be asked to rate whether they found the intervention to be satisfactory and acceptable by completing an additional questionnaire on completion on treatment.
Interventions
A randomised single-case experimental multiple baseline design, which includes a set sequence of phases: baseline, CBT-I, follow-up. The baseline duration is randomly determined. The baseline duration will be either 7 or 14 days. The duration of follow-up is 7 days. Cognitive behavioural therapy for insomnia (CBT-I) will be used in the study. This treatment aims to develop a consistent sleep-wake schedule and strengthen the association between bed and sleep by limiting time awake in bed. Partici
A randomised single-case experimental multiple baseline design, which includes a set sequence of phases: baseline, CBT-I, follow-up. The baseline duration is randomly determined. The baseline duration will be either 7 or 14 days. The duration of follow-up is 7 days. Cognitive behavioural therapy for insomnia (CBT-I) will be used in the study. This treatment aims to develop a consistent sleep-wake schedule and strengthen the association between bed and sleep by limiting time awake in bed. Participants will receive 4 x weekly sessions lasting 75-min each of individual manualised CBT-I that will include: sleep education, sleep hygiene, stimulus control and sleep restriction, and relapse prevention. Parents will also be involved in treatment. Homework will be assigned to participants each session, including maintaining a sleep diary during the treatment period. Participants will also be required to wear an actigraphy watch and complete a sleep diary during the baseline, follow up and treatment period. Parents will be provided with information about the treatment and asked to support children in the implementation of techniques learned during treatment. The treatment will be conducted by a Clinical Psychologist skilled in CBT and trained in implementation of adapted CBT treatments for insomnia for children with TBI developed for this study.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
11 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
(i) Individuals who have sustained a traumatic brain injury (TBI) of any severity (ii) Aged 11 to 16 years (iii) Receiving outpatient treatment for TBI at the Brain Injury Rehabilitation Program at Sydney Children's Hospital Randwick (iv) Sub-clinical to clinical symptoms of insomnia (i.e., T-score >55 on the Sleep Disturbances Scale for Children) or evidence of reduced sleep quality on Actigraphy. In addition, a structured clinical interview will be conducted prior to commencement of treatment to evaluate children's sleep against the International Classification of Sleep Disorders (ICSD), 2nd Edition.
Exclusion criteria
(i) Individuals and families that are not fluent in English (ii) Aged <11 years (iii) Individuals with sleep disorders that are not amenable to behavioural treatment (e.g., sleep breathing disorder or sleep hyperhidrosis) (iv) Individuals with significant cognitive and/or physical impairments
Outcome results
None listed