Psycho-education in depression - an important step in treatment!

In the patient-practitioner relationship psycho-education is legally required
according to the WGBO (law of medical treatment agreement). A patient has the
right to be informed about his disease or disorder and must be able to value
the diagnostic and treatment options. The multidisciplinary guideline for
depression says 'always start with psycho-education and individual advices in
order to activate the patient and to promote a healthy lifestyle '.

Psycho-education is a didactic intervention: on cognitive and emotional level
experiences will be shared with the patient and his relatives, which leads to
more knowledge and understanding of the disease or disorder the patient suffers
from. The premise is that patients can make their own important decisions about
their treatment instead of depending on the opinion of the practitioner. This
principle also applies to the current development in mental health care in
which patients stay in control as much as possible and in which autonomy and
self-efficacy will be pursued as much as possible.

Research of psycho-education in depression only focused on the prevention of
depression. A meta-analysis of thirteen studies examined the effectiveness of
the course 'coping with depression' (in different variants) on reducing
depression, measured with the BDI (Cuijpers, 1996). Of the participants in
these studies the average BDI score was 21, which means a moderate depression
(range 20-28). The average BDI score after following this course was 9.4. This
comes close to the average BDI score in the general population (7.0), which
means that the participants no longer met the criteria of a depression (mild
depression 14-19). The average effect size was 0.62 (95% confidence interval),
which can be considered as a big effect. In these studies the participants were
recruited by mass media, which can lead to a different population in comparison
to depressive patients following treatment in the specialized mental
healthcare. Most of these studies focused on a course of ten sessions of
psycho-education in combination with cognitive behavioral therapy, which is
more extended than what is generally meant by psycho-education. A meta-analysis
of studies focusing on the prevention of depression showed that participants of
the course 'coping with depression' had 38% less chance of developing a
depressive disorder (Cuijpers et al., 2009).

Valli et al., 2010, showed by means of a literature review (nine Rcts) to the
prevention of depression that post measurements an immediate positive effect of
psycho-education on depression was to see and that this effect at a follow-up
after two years retain remained.

These are promising results, however this may not be without more generalized
to depressive patients within the specialist mental healthcare (or 2nd line).
In these patients, there is often a serious depression that is often associated
with comorbid mental disorders, such as post-traumatic stress disorder and
(cluster C) personality problems, and comorbid physical symptoms such as
headaches and intestinal problems. In addition, patients with major depression
often lead to concentration problems, what the record and retain information
more difficult. It is very unlikely that the course ' coping with depression '
at this serious and complex depressive patients will lead to remission of
depression. This shows once again that the patients within the specialist
mental healthcare not to be compared with the depressed people who participated
in the above studies. That psycho-education in depressive patients within the
specialist mental healthcare important is found, it is clear from the directive
and WGBO multidisciplinary and also seems to general thoughts well with
practitioners, however, is the effect of psycho-education at this Group
depressive patients never examined.

In addition to the above mentioned background of this research, it is important
to investigate the effectiveness of psycho-education in depressed patients
within specialized mental health care. In this study, the focus is on
self-efficacy, because it is expected that psycho-education will increase the
self-efficacy of the patient. It is expected that patients who are well
informed about their disorder and its treatment are better able to make their
own choices. Explorative the study will examine the effect of psycho-education
on the severity of the depression, because this ultimately is the purpose of
treatment for depression.

The ultimate goal of this study is more attention to psycho-education and a
better implementation within settings for treatment of depressive patients. In
practice, the way psycho-education is given (and its quality) differs between
institutions, but also within institutions. It is important that all depressed
patients recieve good psycho-education, regardless of the setting in which they
are treated.

Hypotheses:
Psycho-education given to depressive patients increase their self-efficacy.
Explorative: Psycho-education given to depressive patients decrease the
severity of depression.
Explorative: At 5 weeks follow up the effect on self-efficacy and depression is
retained.

Design:
Randomized Controlled Trial (RCT)
Subjects will be randomly assigned to the intervention or control condition by
a randomization program.
Intervention condition: Subjects participate in a psycho-education group for
depression.
Control condition: Subjects do not participate in a psycho-education group for
depression.

Instruments:
1. Dutch General Self-efficacy Scale (GSE-scale)
This questionnaire is used to determine the degree of self-efficicy. The
psychometric properties of the Dutch GSE-scale are good (review Dijcks en
Joeris, 2012).
2. Inventory of Depressive Symptomotology (IDS-SR).
This questionnaire is used to determine the severity of the depression. The
psychometric properties of the IDS-SR are good (Rush et al. 1996, Trivedi et
al, 2004). Fried (2017) compared seven in research and practice frequently used
questionnaires of depression and it appeared that the IDS-SR measures the most
symptoms of depression. In outpatients the self report version can be used
(Nolen en Dingemans, 2004).

Questionnaires per moment:
GSE-scale IDS-SR
0 weeks x x
5 weeks x x
10 weeks x x

Power analysis:
F tests-ANOVA: Repeated measures, within-between interaction
Analysis: A priori: Compute required sample size
Input: Effect size f (f) = 0.6 (clinical relevance)
* err prob = 0.05
Power (1-* err prob) = 0.95
Number of groups = 2
Number of measurements = 3
Nonsphericity correction * = 1
Output: Noncentrality parameter * = 16.5600000
Critical F = 3.1000686
Numerator, df = 2.0000000
Denominator df = 88.0000000
Total sample size = 46
Actual power = 0.9566890

N = 46, 23 in the intervention condition and 23 in the control condition.

N=46, waarvan 23 in de interventieconditie en 23 in de controleconditie.
Subjects with missing data will be replaced by more subjects. For this reasen,
more subjects will be recruited. With an estimated drop-out of 20%
approximately 58 (2*29) subjects will be recruited.

Feasibility:
Inclusion criteria: all patients with a depressive disorder and/or dysthymic
disorder, according to the DSM5, who are indicated for treatment at PsyQ
Depression after the intake.
Exclusion criteria: insufficient knowledge of the Dutch language.
Estimated number of participants in a year and 8 months: 58 subjects.
In practice: in a year and 8 months 266 patients participate in the
psycho-education group (2 groups, each consists of 8 patients, 10 times a
year).

Subjects in the intervention condition participate in a psycho-education groups
during five sessions of 1.5 hours. Subjects will be adviced to participate
together with a partner, parent or other close relative. This can increase the
understanding and support of the patient, and attention is also given to their
role and burden. During these meetings the subjects will be informed about and
will share experiences with the diagnosis (symptoms, course, causes, effects),
dealing with a depressed person, sleep and rhythm, exercise and positive
activities, social network and the options for treatment. Two therapists of
PsyQ Depression lead the group and at one of the sessions someone who had a
depression for herself is present.

Subjects in the control condition get no intervention.

Subjects are not at risk and the burden is limited.
Subjects will be assigned to the intervention condition or control condition by
a randomization program.
Subjects in the intervention participate in a psycho-education group for
depression, consisting of five weekly sessions of 1.5 hours.
All subjects (in the intervention and the control condition) fill in two
questionnaires at three different moments. The questionnaires are easy to fill
in and the it takes 10-15 minutes per moment.
(E9 contains a detailed description)