CBT for Insomnia in Adolescents With ADHD

NCT06351930 | Recruiting

• 1 other identifier: EA210473
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement.

Conditions

Insomnia; ADHD

Keywords

Insomnia; ADHD; Adolescents; Youth; CBT-I

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Symptoms

  Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.

  Baseline, week 2&4 of the intervention, one-week post-treatment and post-treatment 3 month.

Secondary Outcomes (17)

• Change in ADHD Symptoms (Self-report)

  Baseline, one-week post-treatment and post-treatment 3 month

• Change in Internalising and Externalising Symptoms (Parent-rated)

  Baseline, one-week post-treatment and post-treatment 3 month

• Change in depressive symptoms (Self-report)

  Baseline, one-week post-treatment and post-treatment 3 month

• Change in anxiety symptoms (Self-report)

  Baseline, one-week post-treatment and post-treatment 3 month

• Change in Sleep Diary Measure - Time in Bed (TIB)

  Baseline, one-week post-treatment and post-treatment 3 month

Study Arms (2)

cognitive behaviour therapy for insomnia (CBT-I) + usual care (UC) group

EXPERIMENTAL

The intervention for the CBT-I + UC group will involve five weekly 50-minute individual, face-to-face sessions of CBT-I. The treatment components aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia whilst considering the clinical context of ADHD and include: psycho-education about ADHD, sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.

Behavioral: CBT-I + UC group

UC group

NO INTERVENTION

Participants will continue their usual clinical follow-up and receive standard treatment at the clinic.

Interventions

CBT-I + UC group BEHAVIORAL

Refer to the arm description

cognitive behaviour therapy for insomnia (CBT-I) + usual care (UC) group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cantonese-speaking adolescent aged 12-18 years old;
• A diagnosis of ADHD as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
• Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥ 9 (suggested cut-off for adolescents);
• Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
• Being able to comply with the study protocol;
• Those who are not on ADHD medication or have been stabilized on psychostimulant or nonstimulant ADHD medications (maintaining the optimal medication dosage for at least 6 months).

You may not qualify if:

• A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, autism spectrum disorder, organic mental disorders, or intellectual disabilities;
• Having a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe eczema, gastro-oesophageal reflux disease);
• Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
• Concurrent, regular use of psychotropic medications(s) known to affect sleep continuity and quality (e.g., hypnotics, steroids), except for the use of psychostimulant medication for ADHD;
• Receiving ongoing psychological treatment for sleep problems;
• With hearing or speech deficit;
• In the opinion of the research clinician, having a clinically significant suicidality (e.g., with suicidal ideation with a plan or a suicide attempt in the recent one month), and/or endorsing "nearly everyday" for item 9 (suicidal thoughts) in the Patient Health Questionnaire - 9 (PHQ-9).

Sponsors & Collaborators

• The University of Hong Kong: lead
• Kwai Chung Hospital: collaborator

Study Sites (2)

Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital

Hong Kong, Hong Kong

RECRUITING

Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Central Study Contacts

Shirley X Li, PhD, DClinPsy

CONTACT

852-39177035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomised, assessor-blind, parallel group controlled trial

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 8, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)