Treatment of Globus Sensations With Psychotherapy

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial

Conditions
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Globus Hystericus, Somatoform Disorders

Intervention / Treatment
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* Behavioral: Exposure-based psychotherapy for somatic symptoms
* Behavioral: Relaxation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure-based Psychotherapy for Somatic Symptoms<br>First: 1-2 months waiting period; followed by: exposure-based psychotherapy | Behavioral: Exposure-based psychotherapy for somatic symptoms<br>* Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes)<br>* Other names: Exposure-therapy for somatic symptom disorders;|
| Active Comparator: Relaxation Therapy<br>First: 1-2 months waiting period; followed by: relaxation therapy | Behavioral: Relaxation therapy<br>* Progressive muscle relaxation (Jacobson)<br>* Other names: Progressive relaxation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Somatoform disorder, Functional Somatic Syndrome, Functional Somatic Symptoms, Somatic Symptom Disorder, globus sensation, globus pharynges, globus hystericus