Study Protocol for Treatment of Insomnia in Primary Care Study (TIP Study)

Ansa Rantanen, Elina Bergman, Päivi Korhonen, Juha Markkula

Keywords: insomnia, CBT-I

Background:

Chronic insomnia is highly prevalent in Finnish primary care patients. Guidelines suggest cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment, but its availability has been poor. In 2020 and 2021, a structured “Sleep School” group CBT-I method was implemented in health centres of Southwest Finland. The effect and feasibility of the Sleep School method has not yet been studied. Also, its effect on objectively measured sleep is unknown.

Research questions:

The primary aim is to investigate whether Sleep School is an effective treatment to decrease self-reported harm of insomnia among primary care patients, compared to treatment as usual. Sleep School’s long-term effects, and its effects on quality of life, depressive symptoms, and objective measurements of sleep (duration, quality, structure), and patient-related factors affecting its effectiveness are also assessed.

Method:

The TIP study is an open, randomised clinical treatment study conducted among Finnish primary care population. Patients aged ≥18 years who want help with their insomnia symptoms and whose Insomnia severity index (ISI) score is ≥8 are included. The planned sample size is 250 patients. Subjects are randomly assigned to those participating in the Sleep School and to those receiving usual care (short counselling by a nurse) and stratified by sleep medicine use and the severity of insomnia. Self-administered questionnaires are used to gather information about participants’ sociodemographic factors, health, and habits at the baseline and during the follow-up (at 2, 4, 6, and 12 months). Some participants are also followed objectively with a smart watch application. The primary outcome is the ISI score. Linear mixed models are used to analyse repeatedly measured continuous variables. The associations between objective and subjective measurements are assessed with correlation, linear models, or chi-square test, as appropriate.

Results:

Conclusions:

Points for discussion:

Experiences in implementing CBT-I in primary care

Use of objectively measured sleep in detailed diagnosis of insomnia and its treatment