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| Name | Class |
|---|---|
| University of Basel | OTHER |
| Swiss National Science Foundation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure-based Psychotherapy for Somatic Symptoms | Experimental | First: 1-2 months waiting period; followed by: exposure-based psychotherapy |
|
| Relaxation Therapy | Active Comparator | First: 1-2 months waiting period; followed by: relaxation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure-based psychotherapy for somatic symptoms | Behavioral | Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale - indirect (change from baseline) | German version | Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline) |
| Glasgow-Edinburgh Throat Scale (change from baseline) | German version | 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) |
| Functional Esophageal Disorder Module Interview (change from baseline) | German version | 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance & Action Questionnaire (AAQ-II) | German version | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunther Meinlschmidt, Ph.D. | University of Basel, Ruhr-University Bochum | Study Director |
| Roselind Lieb, Ph.D. | University of Basel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel | Basel | 4055 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37730963 | Derived | Imperiale MN, Lieb R, Meinlschmidt G. Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study. Sci Rep. 2023 Sep 20;13(1):15615. doi: 10.1038/s41598-023-42186-y. |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D000079564 | Globus Sensation |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003291 | Conversion Disorder |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D007171 | Implosive Therapy |
| D012064 | Relaxation Therapy |
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003887 | Desensitization, Psychologic |
| D026441 | Mind-Body Therapies |
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| Relaxation therapy | Behavioral | Progressive muscle relaxation (Jacobson) |
|
|
| 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 | German version | 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) |
| Hospital Anxiety and Depression Scale | German version | 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) |
| 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 | German version | 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) |
| Whiteley Index | German version | 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) |
| 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) |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D006990 | Hypnosis |