NCT01590992

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

5.6 years

First QC Date

April 11, 2012

Last Update Submit

October 22, 2018

Conditions

Somatoform DisordersGlobus Hystericus

Keywords

Somatoform disorderFunctional Somatic SyndromeFunctional Somatic SymptomsSomatic Symptom Disorderglobus sensationglobus pharyngesglobus hystericus

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (11)

  • Acceptance & Action Questionnaire (AAQ-II)

    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)

    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

    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

    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

    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 more secondary outcomes

Study Arms (2)

Exposure-based Psychotherapy for Somatic Symptoms

EXPERIMENTAL

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

Behavioral: Exposure-based psychotherapy for somatic symptoms

Relaxation Therapy

ACTIVE COMPARATOR

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

Behavioral: Relaxation therapy

Interventions

Exposure-based psychotherapy for somatic symptomsBEHAVIORAL

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

Also known as: 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
Exposure-based Psychotherapy for Somatic Symptoms
Relaxation therapyBEHAVIORAL

Progressive muscle relaxation (Jacobson)

Also known as: Progressive relaxation
Relaxation Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sufficient spoken and written knowledge of German
  • Presence of globus sensations and somatoform disorder
  • Clinically significant impairment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, 4055, Switzerland

Location

Related Publications (1)

  • Imperiale MN, Lieb R, Meinlschmidt G. Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study. Sci Rep. 2023 Sep 20;13(1):15615. doi: 10.1038/s41598-023-42186-y.

    PMID: 37730963DERIVED

MeSH Terms

Conditions

Somatoform DisordersGlobus Sensation

Interventions

Behavior TherapyImplosive TherapyRelaxation TherapyAutogenic Training

Condition Hierarchy (Ancestors)

Mental DisordersConversion Disorder

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDesensitization, PsychologicMind-Body TherapiesComplementary TherapiesTherapeuticsHypnosis

Study Officials

  • Gunther Meinlschmidt, Ph.D.

    University of Basel, Ruhr-University Bochum

    STUDY DIRECTOR

  • Roselind Lieb, Ph.D.

    University of Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

May 3, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

CH(1)