Treatment of Globus Sensations With Psychotherapy

University Hospital Basel

Status: Completed

Conditions: Somatoform Disorders; Globus Hystericus

Treatments: Behavioral: Relaxation therapy; Behavioral: Exposure-based psychotherapy for somatic symptoms

Study type: Interventional

Funder types: Other

Identifiers

NCT01590992

PT1_135328_A

Details and patient eligibility

About

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).

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 2 patient groups

Exposure-based Psychotherapy for Somatic Symptoms

Experimental group

Description:

First: 1-2 months waiting period; followed by: exposure-based psychotherapy

Treatment:

Behavioral: Exposure-based psychotherapy for somatic symptoms

Relaxation Therapy

Active Comparator group

Description:

First: 1-2 months waiting period; followed by: relaxation therapy

Treatment:

Behavioral: Relaxation therapy