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Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in
Flavia Cortesi1, Flavia Giannotti, Teresa Sebastiani
1Department of Pediatrics and Developmental Neuropsychiatry, Center of Pediatric Sleep Disorders, University of Rome La Sapienza, Italy. flavia.cortesi@uniroma1.it
Insights
Combining melatonin with cognitive-behavioral therapy appears more effective for treating sleep disorders in children with autism spectrum disorder (ASD). This combination showed a trend towards better outcomes and fewer dropouts compared to individual treatments or placebo.
Area of Science:
- Pediatric Sleep Medicine
- Autism Spectrum Disorders (ASD) Research
- Behavioral Therapy and Pharmacology
Background:
- Sleep disturbances are common in children with autism spectrum disorders (ASD), impacting their quality of life.
- Both melatonin and cognitive-behavioral therapy (CBT) have demonstrated effectiveness in managing pediatric sleep issues.
- Limited research exists on the comparative or synergistic effects of melatonin and CBT for ASD-related sleep disorders.
Purpose of the Study:
- To evaluate the relative and combined efficacy of controlled-release melatonin and cognitive-behavioral therapy (CBT) in children with ASD.
- To assess treatment outcomes for sleep onset insomnia and impaired sleep maintenance in this population.
Main Methods:
- A randomized controlled trial involving 160 children (aged 4-10 years) with ASD and sleep onset insomnia/impaired sleep maintenance.
- Participants were assigned to four groups: combination melatonin/CBT, melatonin alone, CBT alone, or placebo, for 12 weeks.
- Treatment response was measured using actigraphy, sleep diaries, and questionnaires, assessing sleep latency, total sleep time, wake after sleep onset, and number of awakenings.
Main Results:
- All active treatment groups showed significant improvements in sleep parameters from baseline to 12 weeks.
- Melatonin primarily reduced insomnia symptoms, while CBT slightly improved sleep latency.
- The combination therapy group exhibited a trend towards superior outcomes, with fewer dropouts and a higher proportion of responders meeting clinical significance criteria (>85% sleep efficiency, <30 min sleep onset latency).
Conclusions:
- Adding cognitive-behavioral therapy to melatonin treatment may enhance treatment response in children with ASD experiencing sleep disorders.
- The combination approach shows promise for improving sleep efficiency and reducing sleep onset latency in the short term.
- Further research is warranted to confirm the long-term benefits and optimal integration of behavioral and pharmacological interventions for pediatric ASD sleep issues.
Abstract:
Although melatonin and cognitive-behavioural therapy have shown efficacy in treating sleep disorders in children with autism spectrum disorders, little is known about their relative or combined efficacy. One hundred and sixty children with autism spectrum disorders, aged 4-10 years, suffering from sleep onset insomnia and impaired sleep maintenance, were assigned randomly to either (1) combination of controlled-release melatonin and cognitive-behavioural therapy; (2) controlled-release melatonin; (3) four sessions of cognitive-behavioural therapy; or (4) placebo drug treatment condition for 12 weeks in a 1 : 1 : 1 : 1 ratio. Children were studied at baseline and after 12 weeks of treatment. Treatment response was assessed with 1-week actigraphic monitoring, sleep diary and sleep questionnaire. Main outcome measures, derived actigraphically, were sleep latency, total sleep time, wake after sleep onset and number of awakenings. The active treatment groups all resulted in improvements across all outcome measures, with moderate-to-large effect sizes from baseline to a 12-week assessment. Melatonin treatment was mainly effective in reducing insomnia symptoms, while cognitive-behavioural therapy had a light positive impact mainly on sleep latency, suggesting that some behavioural aspects might play a role in determining initial insomnia. The combination treatment group showed a trend to outperform other active treatment groups, with fewer dropouts and a greater proportion of treatment responders achieving clinically significant changes (63.38% normative sleep efficiency criterion of >85% and 84.62%, sleep onset latency <30 min). This study demonstrates that adding behavioural intervention to melatonin treatment seems to result in a better treatment response, at least in the short term.
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