Versterken van eigen emotionele veerkracht tijdens behandeling met antidepressiva.

Rationale:
Recent evidence indicates that individual daily life
person-context interactions determine vulnerability for depression, and
predict relapse as well as recovery. We hypothesize that momentary
assessment technology (with the Psy-mate) to monitor these daily life
person-context interactions during treatment will enrich passive
antidepressant pharmacotherapy with an active resource-mobilising
psychotherapeutic context, thus enhancing therapeutic efficacy (reducing
symptoms and relapse rate).

Objective:
(1) Does feedback on continuous
monitoring with the Psy-mate during pharmacotherapy result in a better
treatment response (immediate and follow-up reductions of depressive
symptoms, decreased relapse risk)? (2) Do measurements of daily life
person-context interactions improve the prediction of future courses of
depressive symptoms? (3) Can individual differences in (1) the effect of
feedback on daily life person-context interaction and (2) the predictive
value of these person-context interactions be traced back to genetic
differences?

Study design:
Randomized clinical trial with three groups
of 40 subjects each (2 experimental groups and 1 control group). The
first group receives a 5-day pre- and post Psy-mate assessment and a
continuous Psy-mate assessment (3 days of Psy-mate measurements during
a 6-weeks period) with weekly feedback (to both patient and therapist)
during treatment as usual (TAU). The second group also receives a 5-day
pre- and post Psy-mate assessment and a continuous Psy-mate assessment
(3 days of Psy-mate measurements during a 6-weeks period) but without
feedback during treatment as usual (TAU). The third group receives a
5-day pre- and post Psy-mate assessment but no additional intervention
during TAU. This is the control group.

Study population:
A sample of
patients (n=120) with a depressive disorder will be recruited within (i)
SEARCH, the research network of mental health institutions within
Limburg and South-Brabant, The Netherlands, (ii) general practices and
(iii) the general population.

Intervention (if applicable):
The Psy-mate
is a recently developed wearable interactive palmtop suitable for the
Experienced Sampling Method (ESM) to study subjects in their daily life.
The intervention group receives feedback on Psy-mate measurements of the
experience of positive emotions in daily life.

Main study
parameters/endpoints:
The rate of change in reward experience measured
with the Psy-mate, and the change in depression symptomatology measured
with the Structured Clinical Interview for DSM-IV Axis I Disorders
(SCID-I) and the Hamilton Depression Rating Scale (HDRS).

1. Individualized feedback on the experience of positive emotions in
daily life situations (activities, events and social interactions)
increases the ability of patients to generate positive emotions. In
addition, we hypothesize therefore that the feedback condition combined
with antidepressant treatment compared to antidepressant treatment alone
is more effective in reducing immediate and follow-up depressive
symptomatology and future relapse;

2. Giving individualized feedback on relevant daily life person-context
interactions during pharmacotherapy is cost-effective compared to
treatment as usual;

3. Measurement of relevant dynamic daily life behaviours significantly
contributes to the prediction of the future course of depressive
symptomatology;

4. Individual differences in (i) the effect of feedback on daily life
person-context interactions and (ii) the predictive value of these
person-context interactions can be traced back to genetic differences;

5. Subjects who receive feedback on their experience of positieve
emotions in daily life will develop an increase in feelings of
empowerment compared to subjects who do not receive feedback.

Screening:

Hamilton Depression Rating Scale (HAM-17), Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), personality inventory (NEO-PI), Interview for depression symptomatology (IDS), trauma (Childhood Trauma Questionnaire and Recent life Event Scale), PRODISQ, TiC-P, Euroquol-5D and a saliva sample.



Baseline:
5 days of measurement with the Psy-mate, and after completion of this period: the depression part of the SCID-I, the HAM-17, and the IDS.



Intervention period (week 2 to 8):

1. Intervention group: 3 days/week during a 6 week period of Psy-mate measurements combined with weekly feedback during treatment as usual (TAU);

2. Control group 1: 3 days/week during a 6 week period of Psy-mate measurements without weekly feedback during TAU;

3. Control group 2: no Psy-mate measurements, no feedback during TAU.

At the end of the intervention period, all 3 groups have to complete the depression part of the SCID-I, the HAM-17, the IDS, and the Empowerment questionnaire.



Post intervention measurement:
5 days of measurement with the Psy-mate, and after completion of this period: the depression part of the SCID-I, the HAM-17, and the IDS.



Follow-up measurements:

1. 4 weeks after the intervention period: the depression part of the SCID-I, the HAM-17, and the IDS;

2. 8 weeks after the intervention period: the depression part of the SCID-I, the HAM-17, and the IDS;

3. 12 weeks after the intervention period:the depression part of the SCID-I, the HAM-17, the IDS, TiC-P, PRODISQ, EQ-5D;

4. 24 weeks after the intervention period:the depression part of the SCID-I, the HAM-17, the IDS, TiC-P, PRODISQ, EQ-5D, Interview for Recent Life Events.

The Psy-mate is a recently developed wearable interactive palmtop
suitable for the Experience Sampling Method (ESM) to study subjects in
their daily life. The intervention group receives feedback on Psy-mate
measurements of positive affect in their daily life.