NCT02444026 — Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors · CancerIndex
Clinical trial · Interventional
Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors
Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
The aim is, in a randomized controlled trial, to test the feasibility and evaluate the efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US cancer patients, in a large sample of Danish breast cancer survivors who are experiencing significant sleep problems 0-3 years after treatment. The investigators aim to test the following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep, fewer awakenings during the night, improved sleep efficiency, increased subjective sleep quality, and improved quality of life after the intervention, when compared to a waiting list control group. The investigators also aim to explore a number of possible moderators of the effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Insomnia
—
UNRESOLVED
—
Interventions
Interventions (1)
Intervention
Type
Mapped drug
Match
iCBT for Insomnia
Behavioral
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
iCBT for Insomnia
description
The Internet intervention offered is the SHUT-i program (Sleep Healthy Using The Internet), which is based on the existing consensus concerning non-pharmacological treatment of insomnia and builds on previous validated CBT's for insomnia (CBT -I)
interventionNames
Behavioral: iCBT for Insomnia
type
NO_INTERVENTION
label
Control
description
The control group will be offered the intervention AFTER the study
Primary outcomes (3)
measure
Sleep diary
timeFrame
Up to 7 month
description
The online sleep diaries contains 10 standard questions including information about bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids (medication and/or alcohol use).
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Maximum age
75 Years
Show eligibility criteria text
Inclusion Criteria:
* Reported moderate-to-severe sleep disturbances, defined as a score\> 5 on the Pittsburgh Sleep Quality Index (PSQI).
* Disease free.
* Access to the Internet.
Exclusion Criteria:
* Recurrence of breast cancer
* A second cancer
* Other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD)
* Night work schedule
* Other sleep disorders (sleep apnea, narcolepsy) .
References
Publications (67)
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measure
The Pittsburgh Sleep Quality Index
timeFrame
Up to 7 month
measure
The Insomnia Severity Index
timeFrame
Up to 7 month
Secondary outcomes (9)
measure
Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame
Up to 7 month
measure
Beck's Depression Inventory (BDI-II)
timeFrame
Up to 7 month
measure
State-Trait Anxiety Inventory (STAI)
timeFrame
Up to 7 month
measure
EQ-5D
timeFrame
Up to 7 month
measure
SF-12
timeFrame
Up to 7 month
description
Quality of life (QoL) is measured with the SF-12
measure
Cognitive Failures Questionnaire (CFQ)
timeFrame
Up to 7 month
measure
Sleep habits and sleep-relevant lifestyle
timeFrame
Up to 7 month
description
Is assessed by adapting, further developing, and testing in the first phase of the study an existing instrument (Suzuki E, Tsuchiya M, Hirokawa K, Taniguchi T, Mitsuhashi T, Kawakami N. Evaluation of an internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial. J Occup Health 2008;50(5):387-99.), that measures: activities before bedtime, eating habits before bedtime, use of stimulants (coffee, tea, cola), alcohol, activities in the bedroom, exercise, thought patterns concerning sleep, etc.
measure
Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment
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