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Glucocorticoid Treatment for Social Phobia

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ClinicalTrials.gov Identifier: NCT01574014
Recruitment Status : Terminated (Recruiting problems)
First Posted : April 10, 2012
Last Update Posted : December 5, 2012
Sponsor:
Collaborator:
University of Basel
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date December 5, 2012
Study Start Date  ICMJE July 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
Change from baseline in spider phobia symptoms / social phobia symptoms [ Time Frame: at follow-up visit, expected to be after 3 months ]
measured by various standardized questionnaires
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
  • Change from baseline in state and trait anxiety [ Time Frame: 1-3 weeks before treatment, 4 weeks after treatment, 3 months after treatment ]
    measured by standardized questionnaires
  • Change from baseline in personality traits [ Time Frame: 1-3 weeks before treatment ]
    measured by standardized questionnaires
  • Change from baseline in amygdala activation [ Time Frame: 1-3 weeks before treatment, 4 weeks after treatment ]
    measured by several magnetic resonance sequences
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucocorticoid Treatment for Social Phobia
Official Title  ICMJE Glucocorticoid Treatment for Social Phobia
Brief Summary

Social phobia is the third most common psychiatric disorder besides depression and alcoholism. Several studies have demonstrated the efficacy of cognitive-behavioral therapy in the treatment of social phobia. Nevertheless, there is no effect in a third of the people at the existing treatment methods. Pharmacological therapies have similar effects, but there is a high rate of relapse after discontinuation of medication.

Social phobia is characterized by fear of performance or interaction situations. The strong fear of negative evaluation by others is usually accompanied by a marked avoidance behavior and increased physical symptoms such as blushing, sweating, palpitations, or tremors. The confrontation with a phobic stimulus leads to a retrieval of stimulus-associated aversive memories, resulting in an immediate anxiety response. Several studies had already shown that elevated glucocorticoids impair retrieval of declarative memory contents in healthy subjects. The investigators demonstrated an anxiety-reducing effect after the administration of cortisone before the confrontation with a phobic stimulus in patients with social and spider phobia.

Detailed Description

Background

Anxiety disorders have major public health significance and social phobia ranks as the third most common mental health disorder after depression and alcoholism. Even though cognitive-behavioral therapy (CBT) is the most effective non-pharmacological approach to the treatment of social phobia, more than one third of the patients do not respond to treatment, or achieve only partial remission of symptoms. Pharmacotherapy (e.g., SSRIs, benzodiazepines) has been shown to be effective in the acute treatment of social phobia, however, with high rates of relapse when medication is discontinued. In addition, the combination of CBT and medication does not seem to be more beneficial than CBT alone. Consequently, the development of innovative psychobiological approaches combining effective psychotherapy methods with synergizing substance administration is a primary challenge in interdisciplinary research on treatment of social phobia.

In a recent study the investigators found evidence that a pharmacological elevation of glucocorticoid levels reduces fear in patients with social phobia and spider phobia exposed to a phobic stimulus. Furthermore, the investigators have shown that repeated administration of glucocorticoids before exposure to a phobic stimulus leads to an extinction of phobic fear. Also the low-dose administration of cortisone over a month in patients with post-traumatic stress disorder reduces cardinal of symptoms the disorder. Based on these findings, glucocorticoid treatment, in combination with exposure therapy, may help to reduce fear and promote extinction of phobic fear.

In an interdisciplinary research project involving psychology, behavioral pharmacology psychiatry, genetics and neuroimaging the investigators propose to investigate the therapeutic efficacy of combining an exposure-based cognitive-behavioral group therapy (CBGT) with hydrocortisone treatment. The investigators hypothesize that hydrocortisone exerts both acute beneficial effects by reducing fear during exposure, and long-term beneficial effects by facilitating the extinction of phobic fear. Furthermore, the investigators hypothesize differential treatment responses depending on genetic variations in glucocorticoid-related genes (substudy 1). These hypotheses will be tested in a clinical study with 100 patients with mainly speech anxiety who fulfill DSM-IV criteria for a diagnosis of social phobia and 60 patients with spider phobia.

This is the first study aimed at determining the therapeutic efficacy of combining hydrocortisone administration and a short-term exposure-based cognitive-behavioral group therapy for the treatment of social phobic patients with specific speech anxiety and patients with spider phobia. Considering the large number of patients suffering from social phobia, the suggested interdisciplinary project will have important clinical implications for the development of a more effective therapy.

Objective

To determine whether short-term treatment with 20 mg hydrocortisone enhances the efficacy of exposure-based cognitive-behavioral group therapy (CBGT) in patients with social phobia, specifically speech anxiety and patients with spider phobia.

A series of studies indicate that elevated glucocorticoid levels inhibit the retrieval of memory in healthy humans. Further the low-dose administration of glucocorticoids over a month inhibited the retrieval of traumatic memories in patients with post traumatic stress disorder. These findings suggest that glucocorticoids might also inhibit retrieval of fear memory in phobia and social phobia exposed to a phobic stimulus. Additionally, the investigators found evidence indicating that repeated administration of glucocorticoids before exposure to a phobic stimulus leads to an extinction of phobic fear. Based on these findings, glucocorticoid treatment, in combination with exposure therapy, may help to reduce fear and promote extinction of phobic fear.

Methods

In a placebo-controlled double-blind study design, patients will be randomly assigned to receive CBGT + hydrocortisone (Social Phobia: N=50 / Spider Phobia: N=30) or CBGT + placebo (Social Phobia: N=50 / Spider Phobia: N=30). Psychopathological symptoms and stress reactivity will be assessed by psychometric and endocrine parameters before, during and after CBGT therapy. The patients have further the possibility to attend to a neuroimaging study, in which the investigators examine and localize the anxiolytic effect of acute glucocorticoid administration in the brain (substudy 2). In this substudy 2 the investigators compare the patients with social phobia with patients with specific spider phobia and healthy controls as they did in their previous studies (Soravia et al. 2006).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Phobic Disorders
  • Phobias
Intervention  ICMJE
  • Behavioral: CBGT
    Cognitive-behavioral group therapy
  • Drug: Hydrocortisone
    3 x 20 mg Hydrocortisone (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
  • Drug: Placebo
    Placebo (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
Study Arms  ICMJE
  • Active Comparator: 1: CBGT & Hydrocortisone
    Interventions:
    • Behavioral: CBGT
    • Drug: Hydrocortisone
  • Placebo Comparator: 2: CBGT & Placebo
    Interventions:
    • Behavioral: CBGT
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)
66
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2012)
160
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age (20-55)
  • Spider Phobia
  • Right Handed
  • Social Phobia

Exclusion Criteria:

  • Other Psychiatric Disorder / Comorbidities
  • Smoking more than 15 cigarettes per day
  • Medication
  • Contraceptives
  • Physical illness
  • Neurological disease
  • Drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574014
Other Study ID Numbers  ICMJE 161/07
32003B_124947 ( Other Grant/Funding Number: SNF )
2008DR2002 ( Other Identifier: Swissmedic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE University of Basel
Investigators  ICMJE
Principal Investigator: Leila M Soravia, PhD Department of Psychiatric Neurophysiology, University Hospital of Psychiatry, University of Bern
PRS Account University Hospital Inselspital, Berne
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP