Treatment of Globus Sensations With Psychotherapy

Not Applicable

Completed

• Conditions: Globus Hystericus; Somatoform Disorders
• Interventions: Behavioral: Exposure-based psychotherapy for somatic symptoms; Behavioral: Relaxation therapy

• Registration Number: NCT01590992
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2012-04-11
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure-based Psychotherapy for Somatic Symptoms	Exposure-based psychotherapy for somatic symptoms	First: 1-2 months waiting period; followed by: exposure-based psychotherapy
Relaxation Therapy	Relaxation therapy	First: 1-2 months waiting period; followed by: relaxation therapy

Primary Outcome Measures

Name	Time	Method
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
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
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)
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

Secondary Outcome Measures

Name	Time	Method
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
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)
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)
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
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)
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
Salivary Cortisol Awakening Response	Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
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
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)

Trial Locations

Locations (1)

University of Basel; 🇨🇭 Basel, Switzerland