Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01590992
Other study ID # PT1_135328_A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date December 2017

Study information

Verified date October 2018
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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


Intervention

Behavioral:
Exposure-based psychotherapy 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)
Relaxation therapy
Progressive muscle relaxation (Jacobson)

Locations

Country Name City State
Switzerland University of Basel Basel

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Swiss National Science Foundation, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Global Impression Scale - indirect (change from baseline) German version Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline)
Primary Glasgow-Edinburgh Throat Scale (change from baseline) German version 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)
Primary Functional Esophageal Disorder Module Interview (change from baseline) German version 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)
Primary 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)
Secondary Acceptance & Action Questionnaire (AAQ-II) German version 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 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)
Secondary Daily Symptom Exposure Interview German version 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 Hospital Anxiety and Depression Scale German version 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 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)
Secondary Sheehan Disability Scale German version 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 Whiteley Index German version 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 Salivary Cortisol Awakening Response Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Secondary DNA-methylation Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Secondary 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)
Secondary 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)
See also
  Status Clinical Trial Phase
Completed NCT00276887 - Cognitive Behavior Therapy for Somatization Disorder Phase 2
Enrolling by invitation NCT05565352 - Observation of Ketamine Treatment Safety and Tolerability in Adult Psychiatry Clinic Medical University of GdaƄsk Inpatients
Active, not recruiting NCT04847310 - Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care N/A
Completed NCT05631860 - Psychological Risk Factors for Functional Somatic Disorders
Completed NCT05611606 - Welfare Benefits in Functional Somatic Disorders
Completed NCT02151500 - Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms N/A
Completed NCT00368212 - Integrated Treatment Program for Hypochondriasis in Primary Care Settings Phase 3
Completed NCT00149799 - Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder Phase 3
Terminated NCT02843932 - Subjective Perception of Motor Control During Psychogenic Disorders N/A
Terminated NCT03904784 - School Withdrawal in Adolescents
Recruiting NCT04807933 - Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest N/A
Completed NCT01119469 - Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis Phase 3
Recruiting NCT03188861 - Systematic Screening for Comorbid Psychological Conditions in Cardiac ACSC Patients With Multimorbidity in the ED
Recruiting NCT04835103 - Build a Research Clinic for Somatoform Patients N/A
Completed NCT02346071 - Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes N/A
Completed NCT01518647 - Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4) N/A
Completed NCT01518634 - Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome Phase 2
Recruiting NCT01391897 - Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy N/A
Completed NCT01924715 - Evaluating the Cost Effectiveness of ISTDP: A Quasi Experimental Study N/A
Completed NCT00130988 - DEPENAS: A Psychosocial Intervention for Patients With Medically Unexplained Symptoms Phase 3