D*Phase psychotherapy study - Research on counselling for depression
What works best for whom* and when?

Depression has important consequences, for patients* wellbeing as well as
economically. Treatment has been found effective. Not only medication, but also
different kinds of psychotherapy have been studied and found to work to a
certain extent, to relieve depressive symptoms. Short-term Psychodynamic
Psychotherapy (STSP) has been studied less, but is also promising. In order for
STSP to be considered as a first-choice treatment for depression according to
the Dutch Guidelines for treatment of depression, one more, well-conducted RCT
is needed.
Despite evidence for the effectiveness of different kinds of psychotherapy in
the treatment of depression, a major part of patients does not, or not fully
recover. Beforehand, we cannot predict who will benefit from treatment, and who
will benefit from which kind of treatment. If this were possible, we would be
able to specifically assign patients to a certain kind of psychotherapy, which
would be one possible step towards maximizing treatment effects.
Another step towards maximizing treatment effects would be knowing exactly what
to do if psychological treatment doesn*t have the desired effect. According to
the Dutch Guidelines for the treatment of depression the advice is to shift to
another kind of psychotherapy, but there is no scientific evidence underlying
this choice. According to recent literature, it would be even better to
transfer the patient to another psychotherapist.
Not enough is known about the influence of the working alliance between the
patient and the therapist and we specifically don*t know at what point in time
and treatment the relationship can predict treatment effect. Knowing this is
the key to answering the question if changes could be made earlier in treatment
(eg. a change of therapist) so an optimal decrease in depressive symptoms can
be accomplished.

1. To prove that Short-Term Psychodynamic Psychotherapy (STPP) is in fact
non-inferior to Cognitive Behavioural Therapy (CBT) in the treatment of Major
Depression so it can be considered a treatment of first choice in the Dutch
Guidelines for treatment of Depression.
2. To identify prognostic and prescriptive variables that can predict the
effect of psychotherapy for Major Depression and specifically for CB versus
STPP.
3. Acquiring knowledge about whether, and if so at which moment in time,
individual variation in affect and emotions during the first phase of treatment
of Major Depression predicts treatment effect and if there is a difference
between STPP and CBT.
4. Increasing knowledge about the influence of the therapeutic relation on
treatment effect.
5. Gaining knowledge about an effective policy (change of therapist and/or
change of treatment method) in psychotherapeutic treatment in the case of
initial non-response.
Secondary, we are interested in whose ratings (therapist*s or patient*s), if
significant, are the best predictors of treatment effect, what characteristics
of the therapist influence the working alliance and, lastly, the influence of
protocol adherence and allegiance on treatment effect.

We will conduct a randomized non-inferiority study aimed at proving that STPP
is not inferior to CBT, a well-researched and proven effective treatment for
Major Depression. By conducting post-hoc analyses we will try to gain more
evidence for the prescriptive and prognostic qualities of variables that were
found to predict treatment results in earlier studies. Subjects that can be
considered *non-responders* after the first phase of treatment will be randomly
assigned to three groups. For the first group this means continuing treatment
with another therapist, the second group will, apart from such a change of
therapist, also be offered another form of treatment, and for a third group
nothing changes. Another post-hoc analysis is aimed at finding out what
influence working alliance and characteristics of the therapist have on
treatment effect. An additional group of 30 patients will follow the same
design, but will use a specially designed app to measure individual variation
in affect and emotions shortly before, and during the first four weeks of
treatment.

Subjects will receive 16 treatment sessions of STPP or CBT in the initial phase
of treatment, within 8 weeks. In the second phase, the patients who did not
respond in the first phase will again receive the same number of treatment
sessions.

There are no known risks associated with either of the treatment methods. The
biggest burden for subjects is filling out the questionnaires to assess the
different variables that are needed for answering the primary research
questions. For subjects who respond in phase 1, this will take 3 hours; for
subjects who receive another 8 weeks of treatment, filling out the
questionnaires will take about 3,5 to 4 hours. Patients will get treatment
sessions twice a week, which is relatively frequent compared to treatment as
usual, but by doing this, we expect treatment effects to set in sooner.
Subjects cannot use antidepressant medication, unless the maximal effect has
been reached prior to the start of the study. They are asked not to make
changes with regard to medication, except when necessary, e.g. in case of
crisis or severe side effects. For measuring affect and emotions an Experience
Sampling Method will be used in an additional group of 30 patients, who will be
asked to answer short questions in an app 10 times a day during 3 days a week
for a number of weeks.