Testing the effectiveness of online cognitive behavioral therapy for insomnia compared to waiting list on sleep-efficiency in adolescent and young adults after childhood cancer.

Testing the effectiveness of online cognitive behavioral therapy for insomnia compared to waiting list on sleep-efficiency in adolescent and young adults after childhood cancer. - Managing Insomnia after cancer in adolescents (MICADO-2 project)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50766

Enrollment

Registered

2018-08-01

Start date

2019-01-24

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia sleeplessness

Interventions

Participants that are randomized to the intervention group will receive 5 online sessions within the eCBT-I program i-Sleep over 5-8 weeks supported by an online coach. The coach will be a trained a

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: - insomnia symptoms according to the ISI >= 8 - diagnosed with cancer - diagnosed with cancer within the last 10 years - 12-30 years old at time of study participation

Exclusion criteria

Exclusion criteria: - anti-cancer treatment within the last 6 months - patients receiving palliative therapy - patients that are not able to properly fill out the study questionnaires or participate in the online CBT-I because they are insufficiently fluent in Dutch or have significant cognitive impairment - patients with comorbidities that can affect sleep: retinoblastoma with severely diminished eye-sight, schizophrenia, substance abuse or history of seizure disorder or seizure in the past 12 months - pregnancy or had a baby

Design outcomes

Primary

Measure	Time frame
The main outcome sleep efficiency will be evaluated at baseline (T0), 3 (T3), 6 (T6) and 12 (T12) months after randomization. Sleep efficiency will be measured with a 7-day watch Actigraph (GTX3+) and sleep log. SE contains information on difficulties falling asleep as well as difficulties staying asleep and is therefore often considered the best primary outcome measure as it represents different types of sleep problems.	—

Measure

Time frame

The main outcome sleep efficiency will be evaluated at baseline (T0), 3 (T3), 6 (T6) and 12 (T12) months after randomization. Sleep efficiency will be measured with a 7-day watch Actigraph (GTX3+) and sleep log. SE contains information on difficulties falling asleep as well as difficulties staying asleep and is therefore often considered the best primary outcome measure as it represents different types of sleep problems.

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Secondary

Measure	Time frame
Insomnia: Insomnia Severity Index (ISI) Quality of life: Pediatric Quality of Life Inventory (PedsQL) Fatigue: Checklist Individual Strenght (CIS) Depressive and Anxiety symptoms: Hospital Anxiety and Depression Scale (HADS) Chronic stress: Chronic Stress Questionnaire for Children and Adolescents (CSQ-CA) General questionnaire will also be assessed with suicidality and current psychological treatment for psychopathology on T0 and subjective pain, sleep medication use on T3, T6 and T12. Post-treatment intervention feedback and satisfaction of i-Sleep will be evaluated at T3 with a a 20-item satisfaction questionnaire, adherence and intervention feedback per session.	—

Measure

Time frame

Insomnia: Insomnia Severity Index (ISI) Quality of life: Pediatric Quality of Life Inventory (PedsQL) Fatigue: Checklist Individual Strenght (CIS) Depressive and Anxiety symptoms: Hospital Anxiety and Depression Scale (HADS) Chronic stress: Chronic Stress Questionnaire for Children and Adolescents (CSQ-CA) General questionnaire will also be assessed with suicidality and current psychological treatment for psychopathology on T0 and subjective pain, sleep medication use on T3, T6 and T12. Post-treatment intervention feedback and satisfaction of i-Sleep will be evaluated at T3 with a a 20-item satisfaction questionnaire, adherence and intervention feedback per session.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)