Tailored Care for Somatoform Vertigo/Dizziness

NCT02320851 | Unknown DMC

• 1 other identifier: 01EO1401
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Somatoform Vertigo/Dizziness

Keywords

Somatoform disorder; Functional vertigo/dizziness; Chronic subjective dizziness

Outcome Measures

Primary Outcomes (1)

• 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.

  Improvement at follow-up (12 months after treatment)

Secondary Outcomes (6)

• Generic quality of life

  Improvement at follow-up (12 months after treatment)

• Severity of vertigo

  Improvement at follow-up (12 months after treatment)

• Depression

  Improvement at follow-up (12 months after treatment)

• Anxiety

  Improvement at follow-up (12 months after treatment)

• Somatisation

  Improvement at follow-up (12 months after treatment)

Other Outcomes (1)

• Cost-effectiveness

  Baseline and follow-up (12 months after treatment)

Study Arms (2)

SVD-tailored Integrative Psychotherapy (IPT)

EXPERIMENTAL

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.

Behavioral: SVD-tailored Integrative Psychotherapy (IPT)

Self-help group (SHG)

ACTIVE COMPARATOR

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.

Behavioral: Self-help group (SHG)

Interventions

SVD-tailored Integrative Psychotherapy (IPT) BEHAVIORAL

(see description of corresponding study arm)

SVD-tailored Integrative Psychotherapy (IPT)

Self-help group (SHG) BEHAVIORAL

(see description of corresponding study arm)

Self-help group (SHG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• German Center for Vertigo and Balance Disorders: collaborator

Related Publications (2)

• 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.

  PMID: 34065517 DERIVED

• 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.

  PMID: 26001913 DERIVED

MeSH Terms

Conditions

Dizziness; Somatoform Disorders

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Claas Lahmann, PD Dr. med.

  Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Schmid, Dr. phil. Dipl.-Psych.

CONTACT

+49 (0)89 4140 4398; g.schmid@tum.de

Katharina Radziej, Dipl.-Psych.

CONTACT

+49 (0)89 4140 4398; k.radziej@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 19, 2014

Record last verified: 2014-12