The main purpose of this study is to determine the treatment effects and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
154
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)
Coimbra, Portugal
Insomnia severity
Insomnia Severity Index: validated questionnaire among cancer survivors; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Anxiety
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest anxiety level)
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Depression
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level)
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Health-related quality of life
European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30; World Health Organization Quality of Life - Brief (overall scores 0-100, higher scores indicate higher quality of life)
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Cancer-related fatigue
Multidimensional Fatigue Symptom Inventory-Short Form (overall score -24-96, higher scores denote higher levels of cancer-related fatigue)
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Sleep efficiency
Sleep Diary
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Total sleep time
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Sleep Diary
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Sleep onset latency
Sleep Diary
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Number of nocturnal awakenings
Sleep Diary
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)
Wake after sleep onset
Sleep Diary
Time frame: Changes from baseline to post-intervention (8 weeks after randomization)