None listed
Conditions
Brief summary
The primary purpose of the current study is to evaluate whether a brief behavioural treatment for insomnia (BBT-i) improves sleep for adolescents (aged 12-17 years). We will also monitor mood and behavioural changes using self- and parent-reports. Around 10% of 13-18 year old Australians meet DSM-5 criteria for insomnia and up to 70% of teenagers are sleep deprived. The current solution to this highly prevalent condition is often hypnotic pharmacotherapy, despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Behavioural interventions are recommended as the front-line treatment for sleep disordered behaviour for adolescents, yet both prescription and non-prescription medications are widely used, often in the absence of medical advice. BBT-I provides a potentially effective alternative. BBT-I includes psychoeducation around sleep hygiene, stimulus control (i.e., learning healthy associations with sleep cues), and sleep quality (regulating sleep patterns to enhance sleep quality). Literature supports the appropriateness of behavioural sleep strategies for adolescents. The methods to be used in this study have been used extensively in past child and adolescent research involving various formats/sequences of delivery, albeit in ways that differ to the brief format that is to be evaluated here. Importantly, the specific components of the current sleep program have been used for children as young as 6 years. We expect that adolescents will experience improved sleep after the 3-week intervention period. We also anticipate positive changes in mood (e.g., depression, anxiety and stress) and behaviour (e.g., interactions with parents) after the 3-week intervention period. We will evaluate if any changes are maintained 2-months after the 3-week intervention period.
Interventions
The Brief Behavioral Treatment for insomnia (BBT-i) is designed as a non-randomised, single arm, open label trial.
Informational materials include an adaptation of the Brief Behavioral Treatment for Insomnia workbook (Pittsburgh, 2007).
Information is provided on sleep hygiene, stimulus control and sleep regulation (the three components of the BBT-I, see Troxel et al., 2012). Sleep regulation involves setting sleep and wake times to enhance sleep efficiency (time spent asleep relative to time
The Brief Behavioral Treatment for insomnia (BBT-i) is designed as a non-randomised, single arm, open label trial. Informational materials include an adaptation of the Brief Behavioral Treatment for Insomnia workbook (Pittsburgh, 2007). Information is provided on sleep hygiene, stimulus control and sleep regulation (the three components of the BBT-I, see Troxel et al., 2012). Sleep regulation involves setting sleep and wake times to enhance sleep efficiency (time spent asleep relative to time spent in bed). Sleep regulation is implemented and reinforced during a 3 week in-home trial for participants with clinical and/or sub-clinical patterns of insomnia. The intervention is delivered by a Master’s level student during a face-face consultation. The procedure involves: 1. Initial telephone screening interview to assess eligibility and provide instructions on completing the daily sleep diary (Time 0) 2. An initial face-face consultation to complete consent and deliver the 45-60 minute intervention (Time 1) 3. 2 x 10 minute telephone calls to assess risk and adherence, weekly (i.e., Time 2 & Time 3) for two weeks after Time 1 4. A second face-face consultation to debrief and provide recommendations for better sleep outcomes base on individual findings (participant specific based on self-report adherence and sleep diary records of sleep patterns) (Time 4) 5. Participants will be followed up at 2 months after Trial completion (Time 5) to assess sleep, mood, and behaviour via mail or face-face consultation as indicated by participants at the Time 4 consultation. Personalised sleep titration occurs by adjusting time in bed to achieve sleep efficiency rates of ~85% (time asleep relative to time in bed). Time in bed is managed by adjusting ‘time to bed’ – less time in bed if sleep efficiency is low (i.e., later ‘time to bed’). Adherence is assessed during weekly follow-up. Difficulties adhering to prescribed bed and rise times will be noted and discussed.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Males & Females aged 12-17 years (years 7-10 High School). 2. Able to give informed written consent. 3. Parental/caregiver consent. 4. Literacy in English. 5. Symptoms of Insomnia Disorder (APA, 2013) as identified by parent/caregiver during telephone screening. Symptoms include difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty. 6. The Sleep Condition Indicator scale scores below 20. 7. Never previously treated with CBT-I.
Exclusion criteria
1. Existing diagnosis of a psychiatric disorder as identified by parent/caregiver. 2. Sleep disorders (other than untreated insomnia). 3. Severe cognitive impairment that does not allow participants to consent or follow treatment instructions. 4. Recent time-zone travel (within last 1 month).
Outcome results
None listed