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.

Completed

Conditions: Insomnia
sleeplessness
10040991

Registration Number: NL-OMON50766

Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

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

- 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 <6 months
- shift work employment
- current psychological treatment for a sleeping disorder or psychopathology
- comorbid sleep disorders explain the sleep problems instead of insomnia as
assessed in telephonic screening.
- suicidality
- lack of informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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