Clinical trial NCT01590992: Treatment of Globus Sensations With Psychotherapy
Official title: Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatoform Disorders
Globus Hystericus
Keywords: Somatoform disorder
Functional Somatic Syndrome
Functional Somatic Symptoms
Somatic Symptom Disorder
globus sensation
globus pharynges
globus hystericus
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Swiss National Science Foundation
First posted: 2012-05-03
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression Scale - indirect (change from baseline)
timeFrame: Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline)
measure: Glasgow-Edinburgh Throat Scale (change from baseline)
timeFrame: 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: Functional Esophageal Disorder Module Interview (change from baseline)
timeFrame: 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: Screening for somatoform disorder (SOMS-7) (change from baseline)
timeFrame: 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)
timeFrame: 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: Fragebogen zu Körper und Gesundheit (FKG-SSAS)
timeFrame: 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: Daily Symptom Exposure Interview
timeFrame: 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: Hospital Anxiety and Depression Scale
timeFrame: 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: Positive and Negative Affect Scale
timeFrame: 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: Sheehan Disability Scale
timeFrame: 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: Whiteley Index
timeFrame: 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: Salivary Cortisol Awakening Response
timeFrame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
measure: DNA-methylation
timeFrame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
measure: Questions on adverse/side effects
timeFrame: 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: psychophysiological reaction after symptom-relevant stimulus exposure
timeFrame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
affiliation: University of Basel, Ruhr-University Bochum
name: Gunther Meinlschmidt, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Basel
name: Roselind Lieb, Ph.D.
role: STUDY_DIRECTOR
References: