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Stress sensitisation and psychosis risk.


- candidate number9828
- NTR NumberNTR2963
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2011
- Secondary IDsNL37381.068 CCMO
- Public TitleStress sensitisation and psychosis risk.
- Scientific TitleReactivity to social stress in second generation Moroccan men and siblings of patients with psychotic disorder.
- ACRONYM
- hypothesisWe hypothesize that Moroccan-Dutch differ from native-Dutch in stress reactivity. This difference is not explained by group differences in known non-social risk factors for psychosis. Affirmative findings in the current study would support to the idea that social factors, notably the experience of social exclusion, increase psychosis risk through the mechanism of sensitization. Additionally, we hypothesize that genetic factors can moderate the relationship between exposure to social exclusion and sensitisation to stress. Individuals with such genes might have increased stress reactivity in the first place, but they could also predispose individuals to become sensitised to stress.
- Healt Condition(s) or Problem(s) studiedPsychosis, Stress, Migration, Experience sampling method
- Inclusion criteria1. Male;
2. Age 18-30;
3. Second generation Moroccan or native-Dutch.
- Exclusion criteria1. Mental retardation (IQ < 70) and/or illiteracy;
2. Diagnosis of psychotic disorder.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate31-dec-2012
- Target number of participants160
- InterventionsAfter completing the ESM data collection all participants are exposed to a social stress situation. This involves negative feedback on a personal digital profile given by (fictional) peers. It is varied if feedback is possible discriminatory. All participants get the same feedback, but half are shown same-ethnicity peers and half are shown other-ethnicity peers. In the latter case participants might interpret the information as discrimination. Immediately before and after the exposure participants are tested on the white noise task (measuring psychotic perceptions) and the PANAS (measuring mood). The total procedure takes about 30 minutes.

The current study uses the Social Defeat Stress Task developed by van Winkel and Wichers (unpublished). In this paradigm, participants are asked to present themselves in a profile of the type used on social networks and dating sites. They are told their profile will be rated by 5 peers. They record a 1 minute clip, in which they talk about their interests and their life motto. They are then presented with 5 fake peer profiles, introduced as the profiles of other participants in the experiment. They watch the clips and rate each person on three dimensions (coolness, attractiveness and intelligence) with 1 - 10 marks. They also comment on each rating in a short sentence. The fake peers are matched in age to the participant (+/- 2 years) and are all male. As an addition to the original paradigm, we vary the ethnicity of the peers. Half of the participants in each ethnic group are shown five Moroccan- Dutch profiles and the other half are shown five native-Dutch profiles. In a follow up session the paradigm exposes participants to an experimental social stressor. Participants complete a Positive And Negative Affect Scale (PANAS; visual analogue format) and a white noise task. Participants view their own film clip again. They are then presented with the same type of feedback they generated in the initial session, 3 grades and 3 short comments, by each of the five fake peers. The feedback is moderately negative. By random assignment participants are in a condition with peers of their own ethnicity or not, hence a condition with or without possible ethnic discrimination. Such discrimination is always in the eye of the beholder, since the message content is exactly the same in both conditions, only the message source is varied. To further process the feedback, the participants have to rate to what extent they agree with each of the 15 comments. Finally they are made to believe that they compare unfavourably to the rest of the study population. They then complete the PANAS and the white noise task again. Directly after the end of data collection the participants are thoroughly debriefed about the deception. This involves showing that all participants received the same feedback, and will continue until it is clear to the researcher that the participant has fully understood.
- Primary outcome1. Reactivity (changes in affect and psychotic symptoms) to self-reported stress in daily life, assessed using the Experience Sampling Method (ESM);
2. Changes in affect and psychotic symptoms in response to an experimental social stress situation involving negative feedback from peers.
- Secondary outcome1. Group level differences in reactivity to other forms of (event related, activity) stress;
2. Differences in reactivity to an experimental social stress situation as dependent on the ethnicity of the peers causing the stress.
Controlling for: Family structure, SES, urbanicity, IQ (non-verbal), IQ (verbal), non-clinical psychotic symptoms, depression score, social defeat score, self-other schemas, childhood trauma, psychopathy, discrimination, perception of living environment, self-esteem, childhood care and abuse, drug use, life events, bullying, ethnic identity, perceived effects of stigma.
- TimepointsBriefing with questionnaires, 8 days of experience sampling, intervention and immediate debriefing.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. M.J. Gevonden
- CONTACT for SCIENTIFIC QUERIESMSc. M.J. Gevonden
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University
- PublicationsN/A
- Brief summaryBackground of the study:
It has been suggested that the experience of social defeat / social exclusion is a major risk factor for psychosis. Such experience may account for a large portion of the increased psychosis risk under Moroccan-Dutch, an immigrant group which is unsuccessful in Dutch society and is frequently the subject of discrimination. Research with the Experience Sampling Method has shown that psychosis patients and their siblings react more strongly to daily life stress. Increased stress reactivity meets the criteria for an endophenotype for psychosis. We hypothesize that sensitisation of the stress system through chronic exposure to social stress is an important mechanism leading to increased psychosis risk in migrants. If this is the case, healthy Moroccan-Dutch should show increased stress reactivity and this result should not be explainable by non-social risk factors for psychosis. Understanding the pathogenic mechanism would allow for the development of preventive interventions to improve migrant mental health.

Objective of the study:
To examine whether second-generation Moroccan-Dutch males are sensitised to social stress and whether the sensitisation process might be moderated by genetic vulnerability.

Study design:
2x2x2 full-factorial design with 2 observational factors (ethnicity; family history) and 1 intervention varying whether certain feedback might be discriminating.

Study population:
160 healthy human male volunteers, 18-30 years old. Brothers of patients with psychotic disorder and non-sibling controls. Second generation Moroccan-Dutch men and native-Dutch controls.

Intervention:
Exposure to a social stress situation, involving negative feedback from (fictional) peers. Peers are either members of the own or the other ethnic group.

Primary study parameters/outcome of the study:
1. Reactivity (changes in affect and psychotic symptoms) to self-reported stress in daily life, assessed using the Experience Sampling Method (ESM);
2. Changes in affect and psychotic symptoms in response to an experimental social stress situation involving negative feedback from peers.

Secundary study parameters/outcome of the study:
Group level differences in reactivity to other forms of (event related, activity) stress.
Differences in reactivity to an experimental social stress situation as dependent on the ethnicity of the peers causing the stress.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Briefing, debriefing and all tests and questionnaires can be done at home in 4 hours. ESM is integrated in daily life and takes about 3 hours over a period of eight days. Time investment (7.5 hrs) will be compensated with a monetary reward. Participants will not benefit directly, but will contribute to better prevention of psychotic disorder. Risks of participating are negligible. Second generation Moroccan males are selected as proxy for social exclusion because of consistent reports of a strongly elevated psychosis risk in that group as well as reports of high discrimination rates. Additionally Moroccans are the most numerous minority group in the region. Siblings of patients are a practical proxy for genotypic vulnerability.
- Main changes (audit trail)
- RECORD24-jun-2011 - 12-jul-2011


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