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Tailored Care for Somatoform Vertigo/Dizziness

Primary Purpose

Somatoform Vertigo/Dizziness

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SVD-tailored Integrative Psychotherapy (IPT)
Self-help group (SHG)
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatoform Vertigo/Dizziness focused on measuring Somatoform disorder, Functional vertigo/dizziness, Chronic subjective dizziness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SVD diagnosis
  • Clinically relevant SVD (VHQ sum score > 45)
  • Informed consent

Exclusion Criteria:

  • Insufficient German language ability
  • Insufficient cognitive abilities (Mini Mental State Test (MMST) ≤ 27)
  • Severe and chronic comorbid somatic or mental disease (e.g., suicidality, severe depression, drug addiction)
  • Current psychotherapeutic treatment
  • Living > 50 km away from Munich

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SVD-tailored Integrative Psychotherapy (IPT)

    Self-help group (SHG)

    Arm Description

    IPT is a short-term psychotherapy aiming to ameliorate both physical and psychosocial distress. It emanates from a multidirectional and dynamic relationship among body, mind, and environment irrespective of causality. In a multi-component approach, other elements are integrated into it, such as cognitive-behavioral and psychodynamic techniques, psychoeducation and body-oriented techniques. The IPT intervention tailored to SVD will be delivered for 16 weeks in a manualised setting with one group session per week (à 90 minutes) and one additional booster session three months after the end of the therapy. The group psychotherapy is on a 6-8:1 basis and will be conducted by a psychotherapist trained on the basis of the manual and under regular clinical supervision.

    The experimental condition will be compared to moderated self-help groups without the implementation of additional therapeutic interventions. Those can be classified as low-level non-placebo control. Treatment will consist of 16 weekly moderated SHG sessions (one weekly session à 90 minutes) and one additional booster-session at three months after the end of the control intervention to be delivered on a 6-8:1 basis by a trained SHG moderator under clinical supervision.

    Outcomes

    Primary Outcome Measures

    Vertigo-related quality of life
    Absolute improvement of vertigo-related quality of life on the Vertigo Handicap Questionnaire (VHQ) at 12 months after the 16-week therapy sessions from VHQ at randomisation/baseline.

    Secondary Outcome Measures

    Generic quality of life
    Generic quality of life will be measured using the Quality of Life Questionnaire (EQ-5D).
    Severity of vertigo
    Severity of vertigo will be measured using the Vertigo Symptom Scale (VSS).
    Depression
    Depression will be measured using the Beck Depression Inventory (BDI-II).
    Anxiety
    Anxiety will be measured using the Beck Anxiety Inventory (BAI).
    Somatisation
    Somatisation will be measured using the Patient Health Questionnaire 15 (PHQ-15).
    Computerized Static Posturography and Head Impulse Test
    Both assessments (Computerized Static Posturography and Head Impulse Test) are introduced as state-of-the-art validated objective dimensions that address relevant core elements of the study conditions and allow for the estimation of possible intervention effects independent from the patients' self-reported outcomes.

    Full Information

    First Posted
    December 16, 2014
    Last Updated
    December 18, 2014
    Sponsor
    Technical University of Munich
    Collaborators
    German Center for Vertigo and Balance Disorders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02320851
    Brief Title
    Tailored Care for Somatoform Vertigo/Dizziness
    Official Title
    Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Technical University of Munich
    Collaborators
    German Center for Vertigo and Balance Disorders

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of a manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to somatoform vertigo/dizziness (SVD) subgroups of mental disorders, compared to self-help groups (SHGs) in patients with SVD. The investigators hypothesise that patients who received IPT will demonstrate greater improvement concerning their vertigo-related handicap compared to patients from the SHGs. The investigators will also analyse the cost-effectiveness of experimental and control intervention.
    Detailed Description
    Vertigo/dizziness (VD) is one of the most frequent problems in medicine with a one-year prevalence of 23%. Approximately 50% of the complex VD disorders (i.e., VD is the cardinal symptom and persists > 6 months) are not fully explained by an identifiable medical condition and could be labelled as somatoform vertigo/dizziness (SVD), fulfilling the criteria of somatoform disorder according to ICD-10 or DSM-IV, respectively. SVD shows a high comorbidity rate of other mental disorders, such as anxiety/phobic and depressive disorders. The majority of the patients with SVD suffer severe impairments in their daily and working lives and report a poorer quality of life compared to the patients with organic VD. Although preliminary evidence indicates that psychotherapy may be effective in these patients, the therapeutic options in the treatment of SVD remain unsatisfactory. In this two-armed, single-centre, randomised, controlled, open superiority clinical trial, the long-term efficacy of manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to SVD subgroups of mental disorders will be investigated in patients with SVD compared to self-help groups (SHGs). IPT describes a differentiated psychotherapeutic approach, which combines different therapeutic techniques, such as interpersonal skills and psychodynamic aspects, self-management and symptom management skills, psychoeducation, and relaxation techniques. Within this study, IPT is tailored to SVD including its common mental comorbidity. Patients will be recruited via routine care appointments at the German Centre for Vertigo and Balance Disorders, a specialised tertiary care unit at the Klinikum Großhadern (Ludwig-Maximilians-Universitaet, Munich). Our principal research questions are as follows: Will IPT result in a clinically relevant improvement in vertigo/dizziness-related quality of life? Does this long-term improvement also apply to associated mental symptoms, such as depression, anxiety and somatisation, as well as balance strategies measured by posturography? Is IPT in the long term superior to moderated SVD-SHGs? The investigators hypothesise that the patients who received IPT will demonstrate greater improvement concerning their vertigo-related handicap compared to the patients from the SHGs. The investigators will also analyse the cost-effectiveness of this trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Somatoform Vertigo/Dizziness
    Keywords
    Somatoform disorder, Functional vertigo/dizziness, Chronic subjective dizziness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SVD-tailored Integrative Psychotherapy (IPT)
    Arm Type
    Experimental
    Arm Description
    IPT is a short-term psychotherapy aiming to ameliorate both physical and psychosocial distress. It emanates from a multidirectional and dynamic relationship among body, mind, and environment irrespective of causality. In a multi-component approach, other elements are integrated into it, such as cognitive-behavioral and psychodynamic techniques, psychoeducation and body-oriented techniques. The IPT intervention tailored to SVD will be delivered for 16 weeks in a manualised setting with one group session per week (à 90 minutes) and one additional booster session three months after the end of the therapy. The group psychotherapy is on a 6-8:1 basis and will be conducted by a psychotherapist trained on the basis of the manual and under regular clinical supervision.
    Arm Title
    Self-help group (SHG)
    Arm Type
    Active Comparator
    Arm Description
    The experimental condition will be compared to moderated self-help groups without the implementation of additional therapeutic interventions. Those can be classified as low-level non-placebo control. Treatment will consist of 16 weekly moderated SHG sessions (one weekly session à 90 minutes) and one additional booster-session at three months after the end of the control intervention to be delivered on a 6-8:1 basis by a trained SHG moderator under clinical supervision.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SVD-tailored Integrative Psychotherapy (IPT)
    Intervention Description
    (see description of corresponding study arm)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-help group (SHG)
    Intervention Description
    (see description of corresponding study arm)
    Primary Outcome Measure Information:
    Title
    Vertigo-related quality of life
    Description
    Absolute improvement of vertigo-related quality of life on the Vertigo Handicap Questionnaire (VHQ) at 12 months after the 16-week therapy sessions from VHQ at randomisation/baseline.
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Secondary Outcome Measure Information:
    Title
    Generic quality of life
    Description
    Generic quality of life will be measured using the Quality of Life Questionnaire (EQ-5D).
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Title
    Severity of vertigo
    Description
    Severity of vertigo will be measured using the Vertigo Symptom Scale (VSS).
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Title
    Depression
    Description
    Depression will be measured using the Beck Depression Inventory (BDI-II).
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Title
    Anxiety
    Description
    Anxiety will be measured using the Beck Anxiety Inventory (BAI).
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Title
    Somatisation
    Description
    Somatisation will be measured using the Patient Health Questionnaire 15 (PHQ-15).
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Title
    Computerized Static Posturography and Head Impulse Test
    Description
    Both assessments (Computerized Static Posturography and Head Impulse Test) are introduced as state-of-the-art validated objective dimensions that address relevant core elements of the study conditions and allow for the estimation of possible intervention effects independent from the patients' self-reported outcomes.
    Time Frame
    Improvement at follow-up (12 months after treatment)
    Other Pre-specified Outcome Measures:
    Title
    Cost-effectiveness
    Description
    Cost-effectiveness will be measured as quality-adjusted life years (QALYs) derived from the EQ-5D at baseline and at 12 months after the 16-week therapy sessions. Costs related to absence from work and health care utilisation will be obtained using a modified German version of the Trimbos/iMTA questionnaire for costs associated with Psychiatric Illness (TiC-P).
    Time Frame
    Baseline and follow-up (12 months after treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: SVD diagnosis Clinically relevant SVD (VHQ sum score > 45) Informed consent Exclusion Criteria: Insufficient German language ability Insufficient cognitive abilities (Mini Mental State Test (MMST) ≤ 27) Severe and chronic comorbid somatic or mental disease (e.g., suicidality, severe depression, drug addiction) Current psychotherapeutic treatment Living > 50 km away from Munich
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriele Schmid, Dr. phil. Dipl.-Psych.
    Phone
    +49 (0)89 4140 4398
    Email
    g.schmid@tum.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katharina Radziej, Dipl.-Psych.
    Phone
    +49 (0)89 4140 4398
    Email
    k.radziej@tum.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claas Lahmann, PD Dr. med.
    Organizational Affiliation
    Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34065517
    Citation
    Limburg K, Radziej K, Sattel H, Henningsen P, Dieterich M, Probst T, Dale R, Lahmann C. A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness. J Clin Med. 2021 May 20;10(10):2215. doi: 10.3390/jcm10102215.
    Results Reference
    derived
    PubMed Identifier
    26001913
    Citation
    Lahmann C, Henningsen P, Dieterich M, Radziej K, Schmid G. Tailored care for somatoform vertigo/dizziness: study protocol for a randomised controlled trial evaluating integrative group psychotherapy. J Neurol. 2015 Aug;262(8):1867-75. doi: 10.1007/s00415-015-7784-6. Epub 2015 May 23.
    Results Reference
    derived

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