Sleep is a fundamental human need with large impact on both psychological and somatic functioning. However, for patients with mental disorders, sleep is often disturbed. Across all diagnostic groups, sleep disturbance is one of the most common and disruptive symptoms. For decades it has been assumed that the sleep disturbance these patients experience was a secondary symptom of a primary mental disorder, but recently this has changed. Experimental and clinical data now suggest that there is a reciprocal relationship between sleep disturbance and mental disorders where they perpetuate and aggravate each other. This makes sleep disturbance a potential therapeutic target in the treatment of mental disorders. Evidence emerging the last decade indicate that providing Cognitive Behavior Therapy for Insomnia (CBT-I) to patients with mental disorders not only improves sleep, but also has clinically meaningful effects on their primary mental disorder. However, a major problem has been disseminating CBT-I and few therapists are trained in this intervention. Consequently, most patients receive sleep medication although evidence clearly indicate that CBT-I is more effective and should be the treatment of choice. In this study, the investigators will use a fully automated digital version of CBT-I that might be used to treat a large number of patients while they are still on the waiting list to receive ordinary outpatient treatment in secondary mental health care clinics in Norway. The main goal is to test the effectiveness of digital CBT-I for this patient group.
(27th May 2021) We have revised one of the study exclusion criteria. In the initial protocol we reported that we would exclude individuals with clinical evidence of sleep apnea, namely, we stated that: "Sleep apnea screening: An Epworth Sleepiness Scale (ESS) score >=13, indicative of high levels of objective daytime sleepiness associated with organic sleep disorders and/or positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")." We have now modified the exclusion criterion, so that it is based on the screening question alone. Our updated exclusion criterion is now stated as follows: "Sleep apnea screening: A positive endorsement of a screening question for sleep apnea (the item asks if they "usually or everyday snore and stop breathing and have difficulties staying awake during the day")." i.e. the ESS score is no longer part of the assessment for eligibility for inclusion. The rationale for this change is that several publications and international experts have questioned the reliability and validity of the ESS cut-off score (>=13) when the scale is used in psychiatric outpatient populations (psychometrics in clinical samples are only modest when compared with ESS for screening community-based and/or non-clinical samples). As such ESS score is no longer used as an exclusion criterion, but we will continue to collect these data at baseline assessment and will report the ESS scores for the recruited sample.
At the time of making the amendment, 29 participants had been excluded on the basis of the ESS score.
| Condition | Mental Disorder, Insomnia |
|---|---|
| Treatment | digital cognitive behavioral therapy (dCBT-I), Digital patient education about insomnia (PE) |
| Clinical Study Identifier | NCT04621643 |
| Sponsor | St. Olavs Hospital |
| Last Modified on | 20 September 2023 |
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