Trial document





This trial has been registered retrospectively.
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  DRKS00005709

Trial Description

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Title

Psychological and physiological consequences of exposure to mass media in young women – the role of moderators

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Trial Acronym

TSF

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URL of the Trial

http://www.unifr.ch/psycho/de/research/klipsy/research

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Brief Summary in Lay Language

Mass media promoting unrealistic beauty ideals contribute to the normative discontentment with the own body of a large population of especially young women. In this research project we focus on the influence of daily exposition to beauty ideals in magazines on healthy women and women suffering from different psychological conditions: mixed mental disorder such as anxiety, somatoform and depressive disorders or eating disorders. The experimental group will be exposed to a fashion magazine, the control group to a nature magazine and the reaction of the two groups will be compared.
Therefore we assess the influence of media exposition on body image, mood and eating behavior as well as on the consequent bodily stress response. A negative body image does not only play a major role in the development of eating disorders but also seems to be crucial in the etiology of anxiety and depressive disorders. The project will thus shed light on the role of cognitive distortions such as “thought shape fusion, TSF” where the pure thinking of food and ideal bodies is assumed to be equal to weight gain and food intake. Additionally, components of the individual emotion regulation capacity are in the center of interest. We expect the findings to specify and differentiate existing models of development of a negative body image and the related risk for the development of further mental disorders, especially eating disorders. The results will foster early identification and prevention of especially eating behavior. Specifying the knowledge about the role of cognitive factors and emotion regulation with respect to the susceptibility to beauty ideals promoted via mass media will help to target and improve intervention strategies in eating disorders and beyond.

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Brief Summary in Scientific Language

In today’s modern eloctronical world repeated exposure to thin beauty ideals is part of the daily routine. Data indicate that under certain circumstances, exposure to thin ideals via mass media plays an important role in the development and maintenance of eating disorders (EDs), low self-esteem and depressive feelings in young females. There are also contradicting results, revealing short-term positive effects of exposure to thin ideals. It is thus important to elucidate the specific circumstances under which exposure to thin ideals develops its detrimental impact and to investigate whether these features are more pronounced in EDs than in other mental disorders also related to negative body image. However, despite the striking clinical relevance of detrimental effects of body dissatisfaction, negative affect and disordered eating behavior, the influence of moderators on effects of exposure to the thin ideal in ED samples compared to patients suffering from mixed mental disorders such as depression, somatoform disorders and anxiety disorders as well as to healthy controls has not yet been examined. Consequently, the current study sets out to investigate the following key questions:
(1) Does laboratory induced exposure to thin ideals relate to psychological impairments in terms of body image, affect and eating behavior in 18 to 35 year old female suffering from anorexia and bulimia nervosa (AN, BN) compared to female healthy controls and to a sample of females suffering from mixed mental disorders (depression, somatoform and anxiety disorders)?
(2) How do moderators such as cognitive distortions (“Thought-Shape Fusion, TSF”), and correlates of emotion regulation (ER) moderate the influence of the exposure to thin ideals?
(3) Are these characteristics amenable to change after treatment?
As a second focus it will be explored how exposure to media promoting the thin ideal relates to biological parameter of stress. We combine questionnaire-based and observational data and include biological measures of stress response such as saliva cortisol, alpha-amylase, heart rate and heart rate variability to assess impact of exposure to the thin ideal.
To achieve these interdisciplinary goals, two research groups (Prof. Dr. Simone Munsch, University of Fribourg, Switzerland; Prof. Dr. Silvia Schneider, Ruhr-University Bochum, Germany) provide their expertise for the investigation of ED pathology, negative affect, cognitive style, emotion regulation and psychological aspects of stress. As a specialist in terms of the concept TSF, Jennifer Coelho (Simon Fraser University, Vancouver) is participating as an expert in this study. Developmental aspects of body image and risk behavior in youth are covered by Grégoire Zimmermann (University of Lausanne, Switzerland), expertise on mechanisms transporting thin ideals promoted by mass media is guaranteed by W. Wirth, (University of Zurich) and expertise on computerized procedures for ER assessment is represented by Roberto Caldara (University of Fribourg, Switzerland).
A sample of 250 female participants including patients with AN, BN, depressive, somatoform and anxiety disorders, and healthy women will be recruited in four collaborating Clinics in Switzerland and in the University Clinic in Bochum. This project will provide pertinent findings about the role of moderators influencing the psychological and physiological effects of exposure to thin ideals promoted by mass media in AN and BN patients using an ecologically valid design. Comparing this susceptibility in ED patients to healthy participants and patients suffering from other mental disorder in a cross and longitudinal design will contribute to a better understanding of psychopathological mechanisms maintaining EDs and distinctions from depressive and somatoform disorders. Findings could be used to develop tailored interventions including a training in ER competences as well as cognitive restructuring of distorted beliefs about the own body shape and weight.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005709
  •   2014/02/06
  •   [---]*
  •   yes
  •   Approved
  •   023/12-CER-FR, Kantonale Ethikkommission des Kantons Fribourg, Schweiz Zudem wurde die Studie von den kantonalen Ethikkommissionen der Kantone Aargau, Thurgau und Zürich beurteilt, ebenfalls mit positivem Votum. Es gab keine Leit-Ethikkommission.
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Secondary IDs

  •   U1111-1153-0040 
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Health Condition or Problem studied

  •   F50.0 -  Anorexia nervosa
  •   F50.2 -  Bulimia nervosa
  •   F33 -  Recurrent depressive disorder
  •   F32 -  Depressive episode
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F45 -  Somatoform disorders
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Interventions/Observational Groups

  •   Arm 1 - experimental group

    Exposure material: magazine representing the female thin ideal (Vogue) in the waiting room.

    The study will be conducted with four groups of participants:
    1) patients with Anorexia Nervosa
    2) patients with Bulimia Nervosa
    3) mixed clinical group (patients with depressive, somatoform and anxiety disorders)
    4) healthy control subjects

    The participants in each group are randomly assigned to either the experimental or the control group. The data collection will proceed the same way in all four study groups:

    Pre-assessment, time point T1:
    Week 1) Structured diagnostic interview (DIPS)
    Week 2) Online questionnaires (BDI-II, BAI, BDDQ, RSES, DEBQ, EDE-Q, SATAQ-G, TSF trait, BIS-15, DERS, ASI-R, TPP, PACS)
    Week 3) waiting-room experiment with a media exposure (magazine), imagination task (TSF induction), self-report questionnaires, (ThreeAS, FRS, VAS_body image, VAS_eating, Emoreg state, TSF state, TPP, PACS), assessment of heart rate and of saliva cortisol and saliva alpha-amylase at 9 time points, as well as an emotion recognition experiment (Expression Noise Experiment).
    24h after the experiment: Post Event Processing Questionnaire, PEPQ.

    Post-assessment, time point T2 (three months after the pre-assessment):
    Week 1) Structured diagnostic interview (DIPS)
    Week 2) Online questionnaires (BDI-II, BAI, BDDQ, RSES, DEBQ, EDE-Q, SATAQ-G, TSF trait, BIS-15, DERS, ASI-R, TPP, PACS)
    Week 3) waiting-room experiment with a media exposure (magazine), imagination task (TSF induction), self-report questionnaires, (ThreeAS, FRS, VAS_body image, VAS_eating, Emoreg state, TSF state, TPP, PACS), assessment of heart rate and of saliva cortisol and saliva alpha-amylase at 9 time Points, as well as an emotion recognition experiment (Expression Noise Experiment).
    24h after the experiment: Post Event Processing Questionnaire, PEPQ.
  •   Arm 2 - control group

    Exposure material: neutral magazine (national geographic) in the waiting room
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Outcome:
Body image: FRS, VAS_Body
Mood: ThreeAS
Eating behavior: VAS_Eating
Moderators: cognitive distortions (TSF) emotion regulation (ER)
Time points: T1 (pre), T2 (3 month after pre)

H1.1 We expect that exposure to thin ideal in contrast to neutral magazines causes an impairment of body image (FRS, VAS_body), affect (threeAS), and eating behavior (VAS_eating).

H1.2 We expect that exposure to thin ideal in contrast to neutral magazines is related to more pronounced negative body image (FRS, VAS_body), negative affect (threeAS), and disordered eating behavior (VAS_eating) in individuals with AN (Anorexia Nervosa), BN (Bulimia Nervosa), and the clinical control group (depression, somatoform and anxiety disorders) compared to the healthy control group, both at T1 and less at T2.

H1.3 We expect that exposure to thin ideal in contrast to neutral magazines is related to more pronounced negative body image (FRS, visual VAS_body), negative affect (threeAS), and disordered eating behavior (VAS_eating) in individuals with AN and BN compared to the clinical control group, both at T1 and less at T2.

H1.4 We expect that the impact of thin ideal exposure on negative body image (FRS, VAS_body), negative affect (threeAS), and disordered eating behavior (VAS_eating) is moderated by cognitive style (TSFstate/ TSFtrait) and ER capacity. We expect stronger responses for participants with high TSF and low ER capacity.

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Secondary Outcome

Outcome:
Stress response: salivary cortisol and alpha-amylase; heart rate and heart rate variability
Moderators: cognitive distortions (TSF) and emotion regulation

H2.1 We expect that exposure to thin ideal in contrast to neutral magazines causes a physiological stress response (increase in mean salivary cortisol and alpha-amylase concentrations, heart rate and decrease in heart rate variability).

H2.2 We expect that exposure to thin ideal in contrast to neutral magazines is related to a more pronounced stress response (increase in mean salivary cortisol and alpha-amylase concentrations, heart rate and decrease in heart rate variability) in clinical groups compared to the healthy control group, both at T1 and T2.

H2.3 We expect that the impact of thin ideal exposure is related to a more pronounced stress response (increase in mean salivary cortisol and alpha-amylase concentrations, heart rate and decrease in heart rate variability) in individuals with AN and BN compared to the clinical control group, at T1 and T2.

H2.4 We expect that the impact of thin ideal exposure on stress response (mean salivary cortisol and alpha-amylase concentrations, heart rate and heart rate variability) is moderated by cognitive style (TSFstate/ TSFtrait) and ER capacity.

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Countries of Recruitment

  •   Switzerland
  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/01/01
  •   250
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   35   Years
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Additional Inclusion Criteria

Inclusion criteria for the AN and BN group are based on DSM-5 assessed in face to face diagnostic interview (DIPS) and will be ascertained by the EDE-Q.

For the mixed mental disorder group, depressive, somatoform and anxiety disorders will be evaluated using the DIPS and will be ascertained by BDI-II, SOMS and BAI.

Inclusion criteria for the healthy control group are absence of past or present mental disorder according to the DIPS. For both, the healthy and the mixed mental disorders group the absence of EDs and the absence of a subclinical level of disordered eating behavior (EDE-Q general score below 2.5) is required.

Further inclusion criteria that apply to all groups are of 18 to 35 years of age, female gender, availability for and capability of study participation; informed consent, sufficient German language skills.

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Exclusion Criteria

Exclusion criteria are pregnancy, psychotic disorders, and serious medical conditions having an effect on eating and mood. Individuals are all asked to report whether they receive medical prescriptions.

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Addresses

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    • Universität Fribourg, Schweiz Lehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  Prof. Dr.  Simone  Munsch 
    • Rue de Faucigny 2
    • 1700  Fribourg
    • Switzerland
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    • Klinische Kinder- und JugendpsychologieRuhr-Universität Bochum
    • Ms.  Prof. Dr.  Silvia  Schneider 
    • Universitätsstrasse 150
    • 44780  Bochum
    • Germany
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    • Universität Fribourg, SchweizLehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  Prof. Dr.  Simone  Munsch 
    • Rue de Faucigny 2
    • 1700  Fribourg
    • Switzerland
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    • Universität Fribourg, SchweizLehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  Prof. Dr.  Simone  Munsch 
    • Rue de Faucigny 2
    • 1700  Fribourg
    • Switzerland
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Sources of Monetary or Material Support

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    • Schweizerischer Nationalfonds (SNF)
    • Mr.  Dr.  Thomas  Zimmermann 
    • Wildhainweg 3
    • 3001  Bern
    • Switzerland
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/08/10
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.