Effects of CBT-I on Impulsivity and Risk Taking in Youths With Insomnia

Официальное название

Effects of Cognitive Behavioural Therapy for Insomnia (CBT-I) on Impulsivity and Risk Taking in Youths With Insomnia: A Randomised Controlled Trial

Обзор

Insomnia is prevalent in adolescents. Impulsive behaviours and excessive risk-taking have been linked to the manifestation of psychopathology in youths. Previous research based on behavioural and neurophysiological measures has found that individuals with insomnia demonstrated impaired inhibitory control, which is associated with detrimental outcomes such as substance abuse and self-harm. Existing evidence has shown some positive effects of cognitive behavioural therapy for insomnia (CBT-I) on insomnia symptoms and daytime functioning in youths. Given the link between insomnia and impulsivity reported in previous research, and sleep as a highly modifiable factor, we are conducting this randomised controlled trial to examine the impact of CBT-I in improving impulsivity and risk-taking in youth with insomnia.

Подробное описание

A randomised, assessor-blind, parallel-group controlled trial will be conducted on youths with insomnia. The study aims to test the effects of CBT-I on impulsivity in adolescents, as assessed through both self-report and objective measures when compared with the psychoeducation control. Eligible participants will be randomised to either group-based CBT-I or psychoeducation control condition. Randomisation will be carried out using an automated online system. Assessments will be conducted at pre-treatment (week 0) and post-treatment (week 7/one-week after the last group session), as well as post-treatment 6 months in order to examine the maintenance effects following the CBT-I intervention.

Вмешательства

• Поведенческое Cognitive Behavioural Therapy for Insomnia
  CBT-I consists of 6 weekly group sessions (90-min, 5-8 adolescents in each group) delivered in the afternoon/evening after school within a 10-week window. The intervention is structured and based on the well-established CBT elements for treating insomnia. The treatment components aim to address the behavioural, cognitive, and physiological factors perpetuating insomnia whilst considering the sleep and circadian features in adolescents and developmental context with the following key elements: ps
• Другое Health-related Psychoeducation
  The active control group will receive group-based health-related psychoeducation, a format that has been adopted in the previous research, in order to provide the credibility of the intervention to the participants, and to control for the potential effects of attention and nonspecific components, e.g., receiving health-related information, expectations of benefit. It will also consist of 6 weekly sessions which contain education on general well-being, diet, and exercise/activity.

Первичные конечные точки

• Change in Impulsivity [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]

Вторичные конечные точки (12)

• Change in Insomnia Symptoms [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Sleep Diary Measure - Time in Bed (TIB) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Sleep Diary Measure - Total Sleep Time (TST) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Sleep Diary Measure - Sleep Onset Latency (SOL) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Sleep Diary Measure - Sleep Efficiency (SE) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Actigraphy- based Measure [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Objective Cognitive Performance (Cued Go/NoGo) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Objective Cognitive Performance (Balloon Analogue Risk Task) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Objective Cognitive Performance (Delay Discounting Task) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change of Objective Cognitive Performance (Information Sampling Task) [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change in ERP components on the Cued Go/NoGo task [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]
• Change in ERP components on the Balloon Analogue Risk Task [Срок оценки: Baseline, one week after the intervention and 6-month after the intervention]

Критерии участия

Критерии включения

• Chinese aged 12-24 years old
• Written informed consent of participation in the study is given by the participant and his/her parent or guardian (for those aged under 18)
• Willing to comply with the study protocol
• Meeting the DSM-V diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)

Критерии исключения

• A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities
• Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease)
• Having a clinically diagnosed sleep disorder (other than insomnia disorder) that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria
• Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter OTC medications (e.g. melatonin, Traditional Chinese Medicine, TCM)
• In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt)
• Currently receiving any psychological treatment for insomnia
• With hearing or speech deficit
• Night shift worker

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kon — Гонконг

Идентификаторы

NCT: NCT07399964 · EA230518

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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