We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Globus Sensations With Psychotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590992
First Posted: May 3, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Basel
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
The purpose of this study is to determine whether psychotherapy (based on exposure techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform Disorders (as exemplified here in subjects with globus sensations in the throat).

Condition Intervention Phase
Somatoform Disorders Globus Hystericus Behavioral: Exposure-based psychotherapy for somatic symptoms Behavioral: Relaxation therapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Clinical Global Impression Scale - indirect (change from baseline) [ Time Frame: Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline) ]
    German version

  • Glasgow-Edinburgh Throat Scale (change from baseline) [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Functional Esophageal Disorder Module Interview (change from baseline) [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Screening for somatoform disorder (SOMS-7) (change from baseline) [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]

Secondary Outcome Measures:
  • Acceptance & Action Questionnaire (AAQ-II) [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Fragebogen zu Körper und Gesundheit (FKG-SSAS) [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
  • Daily Symptom Exposure Interview [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Hospital Anxiety and Depression Scale [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Positive and Negative Affect Scale [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
  • Sheehan Disability Scale [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Whiteley Index [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
    German version

  • Salivary Cortisol Awakening Response [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline) ]
  • DNA-methylation [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline) ]
  • Questions on adverse/side effects [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy) ]
  • psychophysiological reaction after symptom-relevant stimulus exposure [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline) ]

Estimated Enrollment: 175
Study Start Date: May 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exposure-based Psychotherapy for Somatic Symptoms
First: 1-2 months waiting period; followed by: exposure-based psychotherapy
Behavioral: Exposure-based psychotherapy for somatic symptoms
Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes)
Other Names:
  • Behavioral therapy for somatic symptoms
  • Behavioural therapy for somatic symptoms
  • Exposure-therapy for somatic symptoms
  • Exposure-based psychotherapy for somatoform disorders
  • Behavioral therapy for somatoform disorders
  • Behavioural therapy for somatoform disorders
  • Exposure-therapy for somatoform disorders
  • Exposure-based psychotherapy for somatic symptom disorders
  • Behavioral therapy for somatic symptom disorders
  • Behavioural therapy for somatic symptom disorders
  • Exposure-therapy for somatic symptom disorders
Active Comparator: Relaxation Therapy
First: 1-2 months waiting period; followed by: relaxation therapy
Behavioral: Relaxation therapy
Progressive muscle relaxation (Jacobson)
Other Name: Progressive relaxation

Detailed Description:
Functional somatic symptoms (FSS) and somatoform disorders are characterized by the presence of medically unexplained symptoms. They are among the most prevalent disorders in the general medical setting, leading to individual suffering and having huge impact on public health alike. Unfortunately, many patients still remain untreated and not all patients get better, even when receiving currently proposed treatments. The aim of the present project is twofold: First, we want to improve the understanding of risk factors and psychobiological processes leading to the development of FSS. Second, we will explore and evaluate new ways of treating subjects with FSS. Within the project, we will examine subjects with globus sensations in the throat, a very common und impairing form of FSS. The proposed study i) may provide insight into the development of FSS, thereby improving our way by which we recognize and diagnose subjects with FSS, and ii) may help fostering our understanding of how to better treat subjects suffering from FSS.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sufficient spoken and written knowledge of German
  • Presence of globus sensations and somatoform disorder
  • Clinically significant impairment

Exclusion Criteria:

  • Current (past 12 months) severe chronic physical illnesses, especially neurological, endocrine or metabolic diseases
  • Current (past 12 months) substance dependence or eating disorder
  • Lifetime history of psychotic disorder or bipolar disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590992


Locations
Switzerland
University of Basel
Basel, Switzerland, 4055
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Swiss National Science Foundation
Investigators
Study Director: Gunther Meinlschmidt, Ph.D. University of Basel, Ruhr-University Bochum
Study Director: Roselind Lieb, Ph.D. University of Basel
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01590992     History of Changes
Other Study ID Numbers: PT1_135328_A
First Submitted: April 11, 2012
First Posted: May 3, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by University Hospital, Basel, Switzerland:
Somatoform disorder
Functional Somatic Syndrome
Functional Somatic Symptoms
Somatic Symptom Disorder
globus sensation
globus pharynges
globus hystericus

Additional relevant MeSH terms:
Somatoform Disorders
Conversion Disorder
Mental Disorders