The overall purpose with this investigation was to increase access to cognitive behavioural therapy for insomnia (CBT-I) by examining CBT-I delivered through a smartphone application The first aim that will be addressed is to explore the efficacy of the smartphone delivered CBT-I on overall insomnia and on nighttime symptoms by comparing CBT-I to a waitlist control in a randomised controlled trial. The second aim is to investigate the effect smartphone delivered CBT-I compared to the waitlist on secondary outcomes related to insomnia, such as stress, anxiety, depression, quality of life and functional impairment. The third aim that will be addressed is to examine what patient characteristics that CBT delivered to a smartphone depend on to be effective with a treatment-moderator strategy. To investigate moderators, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, somatic/psychiatric co-morbidity, and proposed behavioral mediators of sleep restriction and stimulus control will also be employed as moderators. The fourth aim that will be addressed is to examine behavioural processes of sleep restriction and stimulus control as potential mediators of treatment outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.
Karolinska institute
Stockholm, Stockholm County, Sweden
Insomnia severity index
Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.
Work and Social Adjustment Scale
Score: 0-40, with higher scores indicating worse outcome.
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment
Sleep onset latency (SOL)
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Wake time after sleep onset (WASO).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Early morning awakenings (EMA).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Total sleep time (TST).
Time frame: Pretreatment (week 0), post-treatment (week 6).
Depression, anxiety and stress scale-21
Score: 0-63, with higher scores indicating worse outcome.
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Brunnsviken Brief Quality of life index
Score: 0-96, with higher scores indicating better quality of life.
Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.
Bed and rise time variability
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Time in bed (TIB)
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).
Pre sleep arousal scale
Score: 16-80, with higher scores indicating worse outcome.
Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.
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