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Completed

NCT Number: NCT01590992

Treatment of Globus Sensations With Psychotherapy

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).

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Key information

Conditions

Somatoform Disorders Conversion Disorder Globus Hystericus Globus Sensation Mental Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel

Basel, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure-based psychotherapy for somatic symptoms

Behavioral

Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes)

Other names: Behavioral therapy for somatic symptoms, Behavioural therapy for somatic symptoms, Exposure-therapy for somatic symptoms, Exposure-based psychotherapy for somatoform disorders, Behavioral therapy for somatoform disorders, Behavioural therapy for somatoform disorders, Exposure-therapy for somatoform disorders, Exposure-based psychotherapy for somatic symptom disorders, Behavioral therapy for somatic symptom disorders, Behavioural therapy for somatic symptom disorders, Exposure-therapy for somatic symptom disorders

Relaxation therapy

Behavioral

Progressive muscle relaxation (Jacobson)

Other names: Progressive relaxation

Primary outcomes

  1. 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)

    German version

  2. 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)

    German version

  3. 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)

    German version

  4. 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

  1. 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)

    German version

  2. 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)

  3. 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)

    German version

  4. 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)

    German version

  5. 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)

  6. 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)

    German version

  7. 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)

    German version

  8. 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)

  9. DNA-methylation

    Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation
  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 3, 2012
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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