Treatment of Globus Sensations With Psychotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
University of Basel
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01590992
First received: April 11, 2012
Last updated: May 12, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • DNA-methylation [ Time Frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590992

Contacts
Contact: Gunther Meinlschmidt, Ph.D. gunther.meinlschmidt@unibas.ch

Locations
Switzerland
University of Basel Recruiting
Basel, Switzerland, 4055
Contact: Gunther Meinlschmidt, Ph.D.       gunther.meinlschmidt@unibas.ch   
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

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01590992     History of Changes
Other Study ID Numbers: PT1_135328_A
Study First Received: April 11, 2012
Last Updated: May 12, 2014
Health Authority: Switzerland: Swissmedic

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:
Conversion Disorder
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014