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Versterken van eigen emotionele veerkracht tijdens behandeling met antidepressiva.


- candidate number6374
- NTR NumberNTR1974
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2009
- Secondary IDsM09-1935 METC Unimaas
- Public TitleVersterken van eigen emotionele veerkracht tijdens behandeling met antidepressiva.
- Scientific TitleActive mobilisation of psychological resources during passive antidepresant pharmacotherapy.
- ACRONYMREMOD-ID
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteria1. 18-65 years;
2. DSM IV diagnosis of current major depressive disorder or a past DSM-IV diagnosis of major depression with residual symptoms (HAM-17>7);
3. Use of antidepressants;
4. Adequate vision;
5. Sufficient Dutch language skills.
- Exclusion criteria1. Diagnosis of non-affective psychosis, schizo-affective disorder, bipolar disorder or mental retardation;
2. Patients who receive current psychotherapeutic treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2012
- Target number of participants120
- InterventionsThe 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.
- Primary outcomeMain outcomes are pre-post intervention change in:
1. Depressive symptomatology;
2. Daily life emotional experience (in terms on NA and PA) and person-context interaction;
3. Pre-post intervention change on the empowerment questionnaire;
4. Health care comsumption and costs. In addition, long-term outcome will be examined.
- Secondary outcome1. Change in daily life emotional dynamics during the intervention period will be examined in association with future course of depressive symptomatology;
2. Can individual differences in both the effect of feedback on daily life person-context interaction and the predictive value of these daily life emotional dynamics be traced back to genetic variation in polymorphisms related to the brain reward system.
- TimepointsScreening:
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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marieke Wichers
- CONTACT for SCIENTIFIC QUERIES Marieke Wichers
- Sponsor/Initiator University Maastricht (UM), Department of Psychiatry and Neuropsychology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
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).
- Main changes (audit trail)End date of trial: 2-10-2012
Inclusion criteria: 3. ‘Use of antidepressants or moodstabilizers’
Exlusion criteria: (i) diagnosis of bipolar disorder and (ii) receiving current psychotherapeutic treatment are deleted. ‘No (hypo) manic or mixed episode within the past month’ is added.
- RECORD31-aug-2009 - 14-jun-2013


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