The effect of an additional short group cognitive behavioural therapy for insomnia (CBT-I) on depressive complaints in patients with a unipolar depressive disorder and insomnia

Insomnia is defined by the presence of difficulty falling asleep or staying
asleep, for the duration of at least one month (APA, 2000). About one third of
the adults face sleeping problems at some point in their lives, about 10% has
to deal with chronic insomnia. The prevalence of insomnia is 1,5 times higher
for women than men, especially after the beginning of the menopause
(Vandereycken et al., 2008).
Insomnia is a common comorbid disorder with many disorders on Axis 1 of the
DSMI IV TR, especially with a major depressive disorder (Ford et al., 1989)
The start of a major depressive disorder is often preceded by insomnia (Ford et
al., 1989; Ohayon et al., 2003): between 41% and 69% of patients with major
depressive disorder reports the occurrence of insomnia preceding other
depressive symptoms (Ohayon et al., 2003; Johnson et al., 2006)
The chance of developing a major depressive disorder is three times higher for
patients with insomnia, compared to those without insomnia.
Perlis et al. (2007) found that patients with a recurrent depression
experienced insomnia during a couple of weeks preceding the other depressive
symptoms. Possibly, insomnia precedes other symptoms that are associated with
major depressive disorder. This implies that insomnia. could be a predictor for
the recurrence of a depressive episode.
After a successful cognitive behavioral treatment (CBT) of a .depressive
episode, generally about half of the patients still have trouble sleeping
(Carney et al., 2007), which results in a higher risk for the recurrence of the
depression(Perlis et al., 2007).
Cognitive behavioral therapy for insomnia (CBT-I) is a commonly used
evidence-based therapy for insomnia and consists of three components: 1) Sleep
restriction, which concerns the limitation of the number of hours spent in bed
to improve the sleep. 2) stimulus control, which means that the bedroom should
only be used for the purposes of sleeping or sex. 3) Cognitive restructuring,
which includes challenging negative thoughts about sleep to reduce the anxiety
for insomnia (Koffel et al., 2015).
Six studies have shown that CBT-I leads to a significant remission of both
insomnia and depressive symptoms in patients with both disorders (Taylor et
al., 2007; Manber et al., 2008; Manber et al., 2011; Watanabe et al., 2011;
Wagley et al., 2013; Ashworth et al., 2015; Norrel-Clarke et al., 2015).
Significant effect of CBT-I on both insomnia and depressive symptoms is
demonstrated in three of these studies. One study involved a comprehensive
group CBT-I consisting of seven sessions (Manber et al., 2008), the other two
studies involved an individual CBT-I consisting of four sessions ( Watanabe et
al., 2011; Ashworth et al , 2015).

Whether a CBT*I of four sessions is also effective when offered as a group
therapy in the treatment of major depressive disorder with co-morbid insomnia
has not been studied sufficiently. So far the CBT-I group therapy is only
studied as a stand-alone treatment in comparison with relaxation therapy. No
study have been done into the effects of CBT-I group therapy as an addition to
treatment as usual (TAU) for depression in patients with major depressive
disorder and comorbid insomnia.

Aims of this study:
In the current study we want to compare the effects of four sessions CBT-I
group therapy added to the treatment as usual for depression, with the effects
of treatment as usual on patients with a major depressive disorder and comorbid
insomnia. With this study we aim to optimize the treatment of patients with a
major depressive disorder and comorbid insomnia.

Japanese research (Watanabe et al., 2011) concluded that the addition of an
abbreviated version of four individual sessions CBT-I, is probably
cost-effective for patients with persistent sleeping problems and depressive
symptoms (Watanabe et al., 2015).

Research Question
Primary research question: Is Cognitive Behavioral Group Therapy efficacious as
an adjunctive treatment to the treatment as usual in patients with a major
depressive disorder and comorbid insomnia on depressive symptoms?

Hypothesis:
It is hypothesized that four sessions of group CBT-I, in addition to TAU, in
patients with major depressive disorder as the primary diagnosis and comorbid
insomnia, will lead to a greater reduction in both depressive symptoms and
insomnia, compared to only treatment as usual (CBT for depression).

In a randomized controlled trial patients will be offered either four sessions
of group CBT-I in addition to the treatment as usual (TAU) of depression or to
the TAU for depression only. The patients are randomly assigned to one of the
two conditions groups after inclusion. The CBT-I consists of four biweekly
group sessions. Measurements are carried out at the start of the CBT-I, after
the CBT-I (after 8 weeks) and one month after completing the CBT-I. Timing and
the contents of these measurements are the same for both conditions. As soon as
the experimental condition ends, participants from the waiting list condition
will be offered the CBT-I treatment.

Five CBT-I group session are offered by a experienced Mental Health
care-psychologists, and an experienved cognitive behavioral groupworker, with a
frequency of once in every two weeks.The group will consist of a minimum of
four and a maximum of six participants. The sessions have a duration of a 120
minutes each time. Every 10 weeks a new group will start or, if there are
sufficient participants every five weeks, in which case there will be two
groups simultaneously.
The CBT-I is offered according to the CBT-I protocol. The protocol is based on
the published protocol of Carney and Edinger (2008). Translation to Dutch is
done by abbreviating and adjusting the Dutch protocol 'treatment of long-term
insomnia (Verbeek and van de Laar, 2015). The first author of this original
protocol have been responsive in the drafting of the study. The following
topics are covered: Information about sleep, recommendations about sleep
hygiene and abdominal breathing exercises (Session 1) Stimulus control, sleep
restrictions, and progressive muscle relaxation (session 2), cognitive
restructuring and imaginary relaxation exercise (session 3) and
self-management, relapse prevention and mindfulness relaxation (session 4).

This study will cost the participants about 10 hours in total, including 8
hours for the group therapy and about one and half to two hours to fill in
questionnaires (distributed on three occasions). No known risks are
associated with participating in cognitive behavioral therapy for insomnia.