Objectives: 1) to evaluate the effectiveness of the e-CBT-i *i-Sleep* compared to a waiting list condition on sleep efficiency at 3, 6 and 12 months in ACC. 2) to assess the effects of eCBT-I on secondary outcomes: fatigue, quality of life, chronic…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
Background summary
Insomnia after childhood cancer is prevalent (26-28%) and a disabling sleep
disorder impacting quality of life, fatigue, pain and general functioning.
Adolescents after childhood cancer (ACC) may be also at increased risk for
insomnia, being critically ill during a phase of life that is important in the
development of good sleep habits. Currently, screening for insomnia is not
routinely done and guidelines for treatment are lacking within pediatric
oncology. The first-line treatment of insomnia is the cognitive behavioral
therapy for Insomnia (CBT-I)- protocol. However, access this care is often
limited. Therefore, the online CBT-I treatment *i-Sleep* has been developed to
facilitate access via online care. i-Sleep has been shown feasible and
effective in adult (cancer) patients, but it is unknown if online CBT-I is
feasible and effective in adolescents after cancer treatment.
Study objective
Objectives:
1) to evaluate the effectiveness of the e-CBT-i *i-Sleep* compared to a waiting
list condition on sleep efficiency at 3, 6 and 12 months in ACC.
2) to assess the effects of eCBT-I on secondary outcomes: fatigue, quality of
life, chronic stress and psychosocial functioning.
3) To psychometrically assess the responsiveness of the PROMIS sleep item banks
over time.
4) Feasibility and acceptability of i-Sleep in the target population
Study design
Randomized-controlled clinical trial with two conditions: 1) e-CBT-I and 2) a
waiting-list condition, stratified on sleep medication use in the past month.
There are 3 (control group) to 4 (intervention group) measurement at T0, T3, T6
and T12. After T6 participants in the waiting-list condition are offered to
also follow the e-CBT-I.
Intervention
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 and supervised by a clinical
psychologist. Participants in the waiting-list (WL) group will be asked not to
seek any new sleep interventions for the duration of the study. After 6 months
they will be offered the eCBT-I program.
Study burden and risks
The risks for taking part in this study are minimal. Participants will invest
time to complete the e-CBT-I program. The time-burden of the accompanying
measurements per time-point are: wearing an Actigraph for 7 days, sleep log
(+/- 1 minute/day) and filling out questionnaires (25-30 min.). We expect that
participation will improve insomnia complaints and increase the quality of life
of the participants. Patients that are allocated to the WL-group, are therefore
offered the program after 6 months.
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | inschrijving NTR/NCT na goedkeuring METC |
| CCMO | NL65009.041.18 |
| OMON | NL-OMON27901 |