Treatment of Globus Sensations With Psychotherapy
Primary Purpose
Somatoform Disorders, Globus Hystericus
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exposure-based psychotherapy for somatic symptoms
Relaxation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Somatoform Disorders focused on measuring Somatoform disorder, Functional Somatic Syndrome, Functional Somatic Symptoms, Somatic Symptom Disorder, globus sensation, globus pharynges, globus hystericus
Eligibility 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
Sites / Locations
- University of Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exposure-based Psychotherapy for Somatic Symptoms
Relaxation Therapy
Arm Description
First: 1-2 months waiting period; followed by: exposure-based psychotherapy
First: 1-2 months waiting period; followed by: relaxation therapy
Outcomes
Primary Outcome Measures
Clinical Global Impression Scale - indirect (change from baseline)
German version
Glasgow-Edinburgh Throat Scale (change from baseline)
German version
Functional Esophageal Disorder Module Interview (change from baseline)
German version
Screening for somatoform disorder (SOMS-7) (change from baseline)
Secondary Outcome Measures
Acceptance & Action Questionnaire (AAQ-II)
German version
Fragebogen zu Körper und Gesundheit (FKG-SSAS)
Daily Symptom Exposure Interview
German version
Hospital Anxiety and Depression Scale
German version
Positive and Negative Affect Scale
Sheehan Disability Scale
German version
Whiteley Index
German version
Salivary Cortisol Awakening Response
DNA-methylation
Questions on adverse/side effects
psychophysiological reaction after symptom-relevant stimulus exposure
Full Information
NCT ID
NCT01590992
First Posted
April 11, 2012
Last Updated
October 22, 2018
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01590992
Brief Title
Treatment of Globus Sensations With Psychotherapy
Official Title
Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Swiss National Science Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatoform Disorders, Globus Hystericus
Keywords
Somatoform disorder, Functional Somatic Syndrome, Functional Somatic Symptoms, Somatic Symptom Disorder, globus sensation, globus pharynges, globus hystericus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure-based Psychotherapy for Somatic Symptoms
Arm Type
Experimental
Arm Description
First: 1-2 months waiting period; followed by: exposure-based psychotherapy
Arm Title
Relaxation Therapy
Arm Type
Active Comparator
Arm Description
First: 1-2 months waiting period; followed by: relaxation therapy
Intervention Type
Behavioral
Intervention Name(s)
Exposure-based psychotherapy for somatic symptoms
Other Intervention Name(s)
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
Intervention Description
Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes)
Intervention Type
Behavioral
Intervention Name(s)
Relaxation therapy
Other Intervention Name(s)
Progressive relaxation
Intervention Description
Progressive muscle relaxation (Jacobson)
Primary Outcome Measure Information:
Title
Clinical Global Impression Scale - indirect (change from baseline)
Description
German version
Time Frame
Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline)
Title
Glasgow-Edinburgh Throat Scale (change from baseline)
Description
German version
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)
Title
Functional Esophageal Disorder Module Interview (change from baseline)
Description
German version
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)
Title
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 Measure Information:
Title
Acceptance & Action Questionnaire (AAQ-II)
Description
German version
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)
Title
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)
Title
Daily Symptom Exposure Interview
Description
German version
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)
Title
Hospital Anxiety and Depression Scale
Description
German version
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)
Title
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)
Title
Sheehan Disability Scale
Description
German version
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)
Title
Whiteley Index
Description
German version
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)
Title
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)
Title
DNA-methylation
Time Frame
Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunther Meinlschmidt, Ph.D.
Organizational Affiliation
University of Basel, Ruhr-University Bochum
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roselind Lieb, Ph.D.
Organizational Affiliation
University of Basel
Official's Role
Study Director
Facility Information:
Facility Name
University of Basel
City
Basel
ZIP/Postal Code
4055
Country
Switzerland
12. IPD Sharing Statement
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Treatment of Globus Sensations With Psychotherapy
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