Treatment of Globus Sensations With Psychotherapy
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
| Active Comparator: Relaxation Therapy First: 1-2 months waiting period; followed by: relaxation therapy |
Behavioral: Relaxation therapy
Progressive muscle relaxation (Jacobson)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Clinical Global Impression Scale - indirect (change from baseline) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)]
- DNA-methylation [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 [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 [Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Sufficient spoken and written knowledge of German
-
Presence of globus sensations and somatoform disorder
-
Clinically significant impairment
Exclusion Criteria:
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Current (past 12 months) severe chronic physical illnesses, especially neurological, endocrine or metabolic diseases
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Current (past 12 months) substance dependence or eating disorder
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Lifetime history of psychotic disorder or bipolar disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PT1_135328_A