Cognitive Remediation Therapy (CRT) as a treatment enhancer in eating disorders and obsessive compulsive disorders

Obsessive Compulsive Disorders (OCD) and Eating disorders (ED) are *according
to the WHO - among the most incapacitating and costly of all mental disorders.
Cognitive behavior treatment and/or medication have proven to be only
moderately successful in both disorders in between 40% and 60% of patients,
leaving much room for more effective treatment algorithms. A striking
underlying deficit shared by both disorders is patients' cognitive
inflexibility, a trait that is likely to hamper treatment engagement and
ability to benefit from treatment. New promising evidence indicates that
Cognitive Remediation Therapy (CRT), an easy-to-use technique, successfully
enhances flexible thinking styles, and therefore enhances benefit from
symptom-based therapies, and improvement of quality of life. Although not
investigated directly, CRT-like strategies have also been effective in
enhancing symptom reduction in OCD.

The objectives of this study are: 1) To investigate the treatment enhancing
effect of CRT in anorexia nervosa/eating disorders not otherwise specified -
subtype anorexia nervosa and OCD (i.e to what extent does CRT lead to shorter
duration of treatment, increased symptom reduction and quality of life, reduced
dropout rates?) 2) To investigate neurocognitive markers of treatment
enhancement by CRT in OCD and ED, i.e. which characteristics determine for
which patients augmentation with CRT is most beneficial in clinical practice?
3)To investigate cost effectiveness and budget impact of CRT on treatment of ED
and OCD

This controlled multicenter trial involves 64 adult patients with ED (anorexia
nervosa/eating disorders not otherwise specified - subtype anorexia nervosa),
and 64 patients with OCD, randomized to 10 bi-weekly sessions with either CRT
or a control condition, followed by TAU which will involve ao weekly sessions
of 60-90 minutes CBT. Additionally, a control group will be included who will
be asked to do the baseline assessment but not the other assessments. Treatment
effect will be analysed using linear mixed model analyses including
calculations of clinically significant change. A Markov modeling approach will
be applied for the economic evaluation. Cost utility analyses will be performed
from a societal perspective estimating the cost per QALY. The budget impact
analysis will be conducted from a payers and societal perspective.
Disorder-specific symptom severity (EDEQ; YBOCS severity scale), Quality of
Life (EQ-5D), cognitive flexibility (D-flex), healthcare use costs, budget
impact, and loss of work productivity will be assessed at baseline, post CRT,
and after 6 and 12 months (or end of treatment) TAU.

Cognitive Remediation Therapy (CRT): CRT consists of ten individual sessions
(45 minutes each), given within six weeks. These CRT sessions are delivered by
trained professionals (therapists, clinical nurses). CRT uses a range of
cognitive (paper and pencil) exercises that are specifically aimed at improving
cognitive flexibility and increasing global information processing as opposed
to detail-oriented processing. Also CRT aims to improve the awareness of
ongoing thinking patterns. Reflection about thinking styles during these
cognitive exercises is a crucial part of CRT. Patients are also encouraged to
find out how these thinking styles affect their daily life and from about the
sixth session onwards, the cognitive exercises are linked to real life
behavioral tasks. These behavioral tasks are designed to allow patients to
practice skills in daily life, thereby introducing more flexible behavior in
their everyday life. A CRT manual is adapted for eating disorders by Tchanturia
et al.2010.


Supportive Counseling Therapy: The placebo treatment condition will entail 10
bi-weekly individual sessions of 45 minutes duration, delivered by
psychologists or trained nurses, adapted from the placebo treatment developed
by Bryant et al. (1998), called: nondirective supportive counseling (SC). This
placebo treatment condition has been used ao in treatment studies of acute
stress disorder. In the first treatment session the rationale of nondirective
supportive counseling will be explained. The subsequent SC sessions will entail
1) education about mental disorders in general, 2) general problem solving
skills, and uncondiotnal support. Further, the patients are encouraged to keep
a diary of current problems and mood
scales (with similar load as for the assignments in CRT). If the patient raises
an issue with respect to his/ her mental illness, treatment goal to be
achieved, inter relational issues or psychosocial situation, no explanations
nor any direct advice is given. The sessions are audiotaped to check for
treatment integrity (therapeutic ingredients).

Riscs are minimal for this study and only related to the research assessments.
Patients are, seeing the TOPGGz status of each of the participating centres,
used to completing questionnaires and doing computertasks. Patients are also
used to answering questions about their symptoms and problems.