Improving medication adherence with Treatment Adherence Therapy in patients with Schizophrenia.

It has been estimated that non-adherence rates for prescribed antipsychotic
medications are about 50% (Cramer & Rosenheck, 1998; Lacro et al., 2002; Nose
et al., 2003; Valenstein et al., 2002). Relapse rates have been shown to be
five times higher in people with schizophrenia who are non-adherent to
medication compared with adherent people, resulting in a significant social and
economic burden (Robinson et al., 1999).
To date, several interventions have been developed to enhance adherence. Each
of these interventions typically target a different aspect of medication
non-adherence. Some focus more on behavioural or practical aspects of
medication intake, others on social, affective or cognitive areas.
Unfortunately, there is no single approach underpinned by convincing evidence
that it is effective (Byerly et al., 2007; van Dulmen et al., 2007). As a
result, professionals remain deprived of proper interventions, guidelines or
recommendations. The Dutch Multidisciplinary Guideline for the treatment of
schizophrenia (2005) notes that cognitive behavioural therapy and family
interventions may be effective in improving medication adherence. However, it
does not provide specific recommendations about how to cope with non-adherence.
Obviously, many patients have no problems adhering to their medication
regimens, and adherence interventions are unlikely to have any effect in these
cases. It would therefore be advisable to make an individual assessment of the
need to take action with respect to medication adherence. Furthermore, if
intervention is indicated, a careful assessment may identify the underlying
cause of non-adherence. Some patients may find side effects intolerable, others
lack insight, or forget to take the medication. As a result, the effectiveness
of any intervention will depend on how well it fits in with patients' needs,
ideas and expectations. Some strategies may not be effective for all patients,
but only for a small subsample. Daily SMS reminders will for instance only be
effective in patients who want to use their medication but find it difficult to
do so regularly. Given this differentiation, it is unlikely that any single
intervention will be effective for the vast majority of patients (Marland &
Cash, 2005). A good example is a study by Hudson et al. (2008), which showed
that patient-tailored strategies to address individual medication adherence
barriers were more effective in improving adherence than a basic implementation
strategy. This also supports the conclusion of several reviewers who found that
complex combinations of strategies are most effective in improving adherence
(Dolder et al., 2003; Haynes et al., 2008; McDonald et al., 2002; Roter et al.,
1998).
Recently Prof. Dr. Mulder and Dr. T. Staring of the Erasmus University have
developed the Treatment Adherence Therapy (TAT). TAT consists of three main
therapeutical modules, based on an empirical theoretical model developed by
Staring (2006). Each of these modules focus on one of three main reasons for
non-adherence; a. cognitive deterioration or poor daily structure resulting in
forgetting of medication mistakes, b. poor subjective medication efficacy and
or adverse side effects, c. deliberate non-adherence due to denial of sickness,
poor medication attitude, not aware of consequences of non-adherence (Staring
et al., 2006). Modules will be deployed based on an extensive assessment of the
underlying cause of non-adherence. TAT is therefore tailored to the needs and
the situation of the patient. If the patient is adherent TAT will not be
deployed. TAT consists of 12 individual weekly sessions and 3 monthly
individual booster sessions. A first randomized controlled trial in 109
outpatients with psychotic disorders, demonstrated that TAT added to TAU
significantly improved service engagement and compliance (Staring et al., 2010).
Given the huge impact of non-adherence, it is important that evidence based
adherence interventions become available. The positive results with TAT are
most promising. Therefore, in this study proposal, we would like to further
examine the effectiveness of TAT added to treatment as usual in patients with
schizophrenia.

The primary objective of this study is to evaluate in a randomized controlled
clinical trial the clinical effectiveness of TAT on the proportion of
medication non-adherent patients over 24 months, in schizophrenia outpatients
who have poor medication adherence, compared with treatment as usual.

Patients will be allocated at random to either TAU or TAU with added TAT. TAU
consists of the regular care that patients receive at our FACT teams for severe
mental illness patients. This care is provided by an experienced
multidisciplinary team and typically consists of regular outpatient visits and
medical treatment. The experimental TAT intervention will last 10 weekly
sessions in the first three months, and 3 monthly booster sessions in the
following three months. Assessment of outcome variables will be performed at
baseline prior the start of the intervention, and 12 and 24 months later.

Secondary objectives of this study are:
1. The effect of added TAT on (re-)hospitalization, quality of life,
functioning, therapeutical alliance, psychopathology, insight, and medication
treatment satisfaction.
2. Cost effectiveness of added TAT compared with TAU.

A randomized controlled clinical trial comparing the effectiveness of added
Treatment Adherence Therapy (TAT) to Treatment As Usual (TAU), versus TAU alone.

Time-schedule; recruitment: months 1-3, intervention: months 2-7, follow-up
assessments: months 2-26, data-analysis/reporting: months 26-30.

Treatment Adherence Therapy (TAT) has recently been developed by Prof Dr Niels
Mulder en Dr Tonnie Staring (Erasmus Universiteit, Rotterdam). TAT consists of
three main therapeutical modules, based on an empirical theoretical model
developed by Staring (2006). Modules will be deployed based on an extensive
assessment of the underlying cause of non adherence. TAT is therefore tailored
to needs and situation of the patient. TAT consists of 10 individual weekly
sessions followed by 3 monthly individual booster sessions.

Treatment As Usual
Treatment as usual consists of regular outpatient care according to the
principles of FACT.

Benefits:
All subjects receive unrestricted TAU.
Subjects allocated to the experimental trial arm will be offered an additional
intervention for which there is evidence to suggest that this will improve
their medication adherence and consequently reduces risk for relapse and
hospitalization.

Risks:
We see no risks associated with participating in this study.