Sleep therapy with or without bright light for teens with ADHD and insomnia

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for young people aged 10-24 years with ADHD, insomnia (trouble sleeping) and a late body clock (evening type). It tests group sleep therapy (CBT-I) with or without morning bright light therapy.

Age

10-24 years

Sex

All sexes

Disease stage

ADHD confirmed by DISC-IV. Insomnia disorder by DSM-5, with a score of ≥ 9. Evening type on the MEQ questionnaire, with late sleep onset on at least 3 nights per week in the past 3 months, confirmed by a 7-day sleep diary. Late sleep onset means 11:15pm or later at age 12, 11:30pm or later at 13-14, 12:00am or later at 15-17, and 10:56pm or later at 18-24.

Earlier treatment

People can join if they take no ADHD medicine, or if their ADHD medicine has been stable for at least 6 months. They cannot be in ongoing psychological treatment for sleep problems.

Main reasons for not taking part

• Substance abuse or dependence, or a current or past history of mania or hypomania, schizophrenia, autism (ASD), organic mental disorders or intellectual disability
• A major medical condition that affects sleep (for example severe eczema, GERD) or another diagnosed sleep disorder, such as narcolepsy, breathing problems during sleep or restless leg syndrome
• Regular use of medicines that affect sleep, such as hypnotics, steroids, melatonin or Traditional Chinese Medicine (ADHD stimulants are allowed)
• Hearing or speech problems
• Serious suicidal thoughts with a plan, or a suicide attempt

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 10 and 24 years old?YesNo

What the trial wants to find out

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by persistent inattention, hyperactivity, and impulsivity. In adolescents and young people, ADHD is commonly accompanied by insomnia and circadian delay. These co-occurring sleep and circadian disturbances may negatively affect daytime functioning and overall clinical outcomes. Although cognitive behavioural therapy for insomnia (CBT-I) is considered the first-line treatment for insomnia, and bright light therapy may help address circadian issues, their efficacy in adolescents with ADHD and comorbid insomnia and eveningness remains unexplored. This study aims to evaluate whether CBT-I, with or without bright light therapy, improves insomnia, sleep, and circadian as well as other clinical outcomes, and cognitive functioning in youths with ADHD and whether these interventions can also lead to improvements in mood and other clinical symptoms, as well as cognitive functioning.

The 3 groups in the trial

• CBT-I with Bright Light TherapyTreatment being tested

  The intervention for the CBT-I plus bright light therapy group will involve six weekly 90-minute group-based, face-to-face sessions of CBT-I, together with daily home-based morning bright light therapy starting from week 2. The CBT-I components are designed to address the behavioural, cognitive, and physiological factors that perpetuate insomnia while taking into account the sleep and circadian features of adolescents with ADHD, and include psychoeducation about sleep, circadian rhythm, and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring, and relapse prevention. Bright light therapy will be administered at home using a portable light device for 30 minutes each morning, with timing individually determined and adjusted according to weekly sleep diary data.

  Treatment: CBT-I with Bright Light Group

• CBT-I with Placebo Light TherapyTreatment being tested

  The intervention for the CBT-I plus placebo light therapy group will involve six weekly 90-minute group-based, face-to-face sessions of CBT-I delivered, together with daily home-based morning placebo light therapy starting from week 2. The CBT-I components are designed to address the behavioural, cognitive, and physiological factors that perpetuate insomnia while taking into account the sleep and circadian features of adolescents with ADHD and include psychoeducation about sleep, circadian rhythm, and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring, and relapse prevention. Placebo light therapy will be administered at home using a portable placebo light device for 30 minutes each morning, with timing individually determined and adjusted according to weekly sleep diary data.

  Treatment: CBT-I with Placebo Light Group

• Waitlist controlNo study treatment, for comparison

  Participants in the waiting-list control group will not receive any active intervention during the study period but will complete the same set of assessments as the intervention groups at baseline and at post-waiting. This group will serve as a comparator for evaluating changes in outcomes over time. Participants will continue with their usual care and clinical follow-up as appropriate during the waiting period.