Trial document





This trial has been registered retrospectively.
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  DRKS00009741

Trial Description

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Title

Predictors, consequences and changeability of psychoneuroendrocrinologically stress response in social phobia

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The study aims to investigate the relationship between the subjective (e.g. subjective severity of fear) and the physiological response to a social stress event in patients with social phobia.

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Brief Summary in Scientific Language

The study aims is to investigate subjective and endocrinological paramenters of stress response, their psychological predictors and consequences as well as their changeability in patients with social phobia. For this purpose, psychotherapy patients, a waitlist control group and healthy controlls underwent the Trier Social Stress Test (TSST). Thereby central assumptions of the Clark/Wells-Modell for social phobia on the interaction of emotional-cognitive factors and objective physiological parameters of stress reaction are testable.

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Organizational Data

  •   DRKS00009741
  •   2015/12/04
  •   [---]*
  •   yes
  •   Approved
  •   EK137062007, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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

  •   F40.1 -  Social phobias
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Interventions/Observational Groups

  •   Treatment group: Patients with Social Phobia who got 25 sessions cognitive therapy à 50 minutes according to the manual of Stangier, Clark and Ehlers (2006) between the first and the second measuring time. At three measuring time (before therapy, after, therapy, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated.
  •   Waitlist control group: Patients with Social Phobia who got no intervention between the first and the second measuring time. At three measuring time (before wait time, after wait time, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated.
  •   Health controls: Healthy participants who got no intervention between the first and the second measuring time. At three measuring times (pre, after 4-6 month, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Reduction in the Liebowitz Social Anxiety Scale (LSAS; German version: Stangier & Heidenreich, 2005) between baseline and post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.

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Secondary Outcome

Blood or plasma cortisol during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) at baseline and at the post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2009/10/02
  •   125
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Diagnosis of social phobia according to the DSM-IV as primary diagnosis as well as a sum score > 30 in the Liebowith social anxiety scale (LSAS)

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Exclusion Criteria

Psychotic Disorder (acute or lifetime); Self-endangerment; current substance disorder; current personality disorder except avoidant, compulsive or dependent personality disorder; organically caused mental disorder; serious physical illness; current psychotherapeutic or psychopharmacological treatment

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Addresses

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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/05
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Trial Publications, Results and other Documents

  •   Klumbies, E., Braeuer, D., Hoyer, J., & Kirschbaum, C. (2014). The reaction to social stress in Social Phobia: Discordance between physiological and subjective parameters. Plos one 9(8): e105670. doi:10.1371/journal.pone.0105670
  •   Hoyer, J., Baeuer, D., Crawcour, S., Klumbies, E., & Kirschbaum, C. (2013). Depersonalization/ Derealization during acute social stress in social phobia. Journal of Anxiety Disorders 27, 178-187
  •   Ziegler, C. et al. (2015). Oxytocin receptor gene methylation: Converging multilevel evidence for a role in social anxiety. Neuropsychopharmacology, 40, 1528-1538.
  •   Schweden, T.L.K., Pittig, A., Bräuer, D., Klumbies, E., Kirschbaum, C., & Hoyer, J. (2016). Reduction of depersonalization during social stress through cognitive therapy for social anxiety disorder: A randomized controlled trial. Journal of Anxiety Disorders, 43, 99-105.
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* This entry means the parameter is not applicable or has not been set.