(Cost-)effectiveness of a guided online CBT intervention in comparison to care-as-usual for patients with insomnia in general practice

In the Netherlands, most patients that refer to their GPs with sleeping
problems receive medication. Behavioral interventions (psycho-education,
cognitive behavioral therapy) are known to be more effective, but are not often
offered. The present proposal is focussed around an online course (5 sessions)
aimed at treating insomnia.

Primary Objective:
To determine the effectiveness of guided CBT compared to care-as-usual in
treating insomnia in the general practice.

Secondary Objective(s):
Secondary objectives include investigation of cost-effectiveness. Several
variables will be included as potential moderators of treatment effects, e.g.
age, medication use, duration of the sleep problem, and alcohol use.

The proposed study entails a randomized controlled intervention study with two
conditions:
(1) the E-health intervention supported by psycholgical wellbeing practitioners
(PWPs), (2) care-as-usual*. The control group will
gain access to the intervention six months after inclusion.

* Care-as-usual:
In July 2014 an updated version of the Dutch guideline for insomnia in general
practice was published (Workgroup Insomnia NHG, 2014). We will provide the
participating GPs in our study with a written version of the new guideline
(which is also available online as is usual after publication of a guideline).
The guideline distinguishes specific sleep disorders (such as sleep apnea and
restless leg syndrome) from the DSM-5 Insomnia Disorder. The guideline
estimates that 90% of the people presenting with sleep problems suffer from
insomnia disorder, rather than from any other specific sleep disorder. The core
message of the guideline is formulated as:

(1) the preferred insomnia treatment is non-pharmacological,
(2) the GP might consider medication in exceptional situations, and only short
term,
(3) the preferred treatment for short-term sleep problems is psycho-education
and information about sleep hygiene,
(4) for longer term sleep problems the preferred treatment is a combination of
stimulus-control, sleep restriction, relaxation and structured exercise.

The patients in the usual-care (control) group might be treated within the GP
practice (either by GP or PWP), be referred to specialized sleep courses
(practically unavailable in the Netherlands) or be referred to the website of
Teleac where patients can purchase a self-help book (including video material,
but unguided). We will not interfere with the usual care that the individual
GPs offer their patients. It must be noted that even though previous guidelines
also advised to refrain from medication this is still the most offered
treatment for insomnia although there is a high practice variation.

More information can be found in the study protocol, chapter 4.E.

The intervention under study, developed at the VU university, is a 5-week
CBT-based program consisting of psycho-education, sleep hygiene, sleep
restriction, stimulus control, and cognitive restructuring (tackling worrying
and promoting relaxation). A Psychological Wellbeing Practitioner (PWP, Dutch:
POH-GGZ) will offer guidance and feedback to increase motivation and adherence.

The sole burden of participation in this trial will be adhering to the program,
i.e. completing homework assignments and questionnaires. No physical or
physiological fatigue associated with participation is expected. There are no
known risks associated with the investigational treatment.