Overview

This trial is active, not recruiting.

Conditions somatoform disorders, globus hystericus
Treatments exposure-based psychotherapy for somatic symptoms, relaxation therapy
Phase phase 2/phase 3
Sponsor University Hospital, Basel, Switzerland
Collaborator University of Basel
Start date May 2012
End date December 2017
Trial size 175 participants
Trial identifier NCT01590992, PT1_135328_A

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
First: 1-2 months waiting period; followed by: exposure-based psychotherapy
exposure-based psychotherapy for somatic symptoms Behavioral therapy 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)
(Active Comparator)
First: 1-2 months waiting period; followed by: relaxation therapy
relaxation therapy Progressive relaxation
Progressive muscle relaxation (Jacobson)

Primary Outcomes

Measure
Clinical Global Impression Scale - indirect (change from baseline)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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 Outcomes

Measure
Acceptance & Action Questionnaire (AAQ-II)
time frame: 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)
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
DNA-methylation
time frame: 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
time frame: 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
time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.