Trial document




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  DRKS00014375

Trial Description

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Title

Efficacy of an Internet-based intervention for somatic symptoms in university students (iSOMA): a randomized controlled trial

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Trial Acronym

iSOMA - online training

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URL of the Trial

https://klipsy.uni-mainz.de/forschung/isoma/

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Brief Summary in Lay Language

Persistent somatic symptoms and medically unexplained symptoms are common in university students and are associated with mental distress and reduced quality of life. Internet-based Trainings are promising, effective and low-threshold isntruments in health promotion. This study thus aims to evaluate the effectiveness of an e-coach guided Internet-based training for somatic symptoms and related disstress in a nation-wide sample of university students. The interactive training will be hosted on a secure web-plattform and includes seven weekly lectures covering different aspects of coping mechanisms based on established psychological intervention techniques. The trial will examine efficacy of the training compared to a waitlist control group, which is given access to the training later. University students will be recruited in Germany, Austria and Switzerland via the internet as well as on-site universities. Surveys will take place before and after the training in order to evaluate effectiveness concerning somatic symptoms, depression, anxiety, quality of life, health care utilization, attitutes towards psychotherapy, satisfaction and acceptance of the training. It is expected that these parameters are positively influenced by the training.

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Brief Summary in Scientific Language

Objective: Persistent somatic symptoms and medically unexplained symptoms (MUS) are common in university students and are associated with mental distress and reduced quality of life. However, individuals seldomly find their way into psychosocial interventions that have been proven to be effective in somatic and mental symptom reduction. In this regard, Internet-and mobile based interventions (IMIs) are promising, low-threshold and efficient interventions for health promotion. This trial this aims to investigate the effectiveness and acceptance of a newly developed internet-based guided intervention for somatoform syndromes in university students.
Methods: The two-armed RCT compares the training with a waitlist control group, which is given access to the training 8 weeks after randomization. A sample size of N = 128 is intended. University students will be recruited in Germany, Austria and Switzerland via the internet as well as on-site universities based on the severity of somatic symptoms (PHQ-15 ≥ 4). Surveys will take place before (t1) and after completion of the training (t2) by the intervention and control group (t3). Primary outcome will be the somatoform syndrome (PHQ-15, SSD-12). Secondary outcomes include depression, (health) anxiety, quality of life, attitutes towards psychotherapy, intervention satisfaction, adherence and acceptance. As potential moderators/mediators of effectiveness, tje following variables will be assessed: somatosensory amplification, emotional reactifity, health care utilization, treatment expectancy, therapeutic alliance, subjective side effects and sociodemographic characteristics.
Discussion: This is the first study examining an Internet-based intervention for somatoform syndromes in German university students. Among the strenghts of this trial are its scalablity, the theoretical and clinical foundation. The trial may give directions to future prevention and treatment options in health promotion in academia and may extend the existing evidence for IMIs in somatic symptom disorders and provide valuable insights into feasiblity, (moderators of) effectiveness and diagnostic indication of IMIs in this population.

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Organizational Data

  •   DRKS00014375
  •   2018/06/20
  •   [---]*
  •   yes
  •   Approved
  •   2017-JGU-psychEK-012 , Ethikkommission des Psychologischen Instituts; Universität Mainz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   somatic symptoms and related distress (measured dimensionally with self-report)
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Interventions/Observational Groups

  •   Intervention group with immediate access after randomization to an e-coach guided internet-based intervention based on principles of Cognitive Behavioral therapy (e. g. coping with stress, attention shift); consisting of seven weekly modules.
  •   Waitlist control group; access to same internet-based training as intervention group (guidance on demand) after waiting period of 8 weeks post-randomization.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Somatic symptom and associated distress measured with the Patient Health Questionnaire (PHQ-15) and the Somatic Symptom Disorder - B Criteria Scale (SSD-12). Measurement before and 8/16 weeks afer randomization.

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Secondary Outcome

Depression (PHQ-9); anxiety (GAD-7); health anxiety (mSHAI); level of functioning (PDI); attitudes towards (face-to-face) psychotherapy (ATSPPH); intervention satisfaction (CSQ-I); adherence (number of completed modules). Measurement before randomisation and 8/16 weeks thereafter. Covariates: demographics; medical variables; somatosensory amplification (SSAS); expectancy (CEQ); emotional reactivity (ERS); therapeutic alliance (WAI-SR); subjective side effects (INEP).

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Austria
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/08/29
  •   154
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

At least moderate somatic symtpoms (PHQ-15 ≥ 4); minimum age 18 years; enrolled as a university student; sufficient knowledge of the German language; Internet access; informed consent

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Exclusion Criteria

/

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Addresses

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    • Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und Experimentelle Psychopathologie
    • Wallstraße 3
    • 55122  Mainz
    • Germany
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    •   [---]*
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    • Universität Ulm; Institut für Psychologie und Pädagogik; Abt. Klinische Psychologie und Psychotherapie
    • Albert-Einstein-Alle 47
    • 89081  Ulm
    • Germany
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    • Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und experimentelle Psychopathologie
    • Ms.  Katja  Böhme 
    • Wallstraße 3
    • 55122  Mainz
    • Germany
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    • Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und experimentelle Psychopathologie
    • Ms.  Katja  Böhme 
    • Wallstraße 3
    • 55122  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und Experimentelle Psychopathologie
    • Wallstraße 3
    • 55122  Mainz
    • Germany
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    • Studicare: Barmer GEK
    • Axel-Springer-Str. 44
    • 10969   Berlin
    • Germany
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Status

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