Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
216 participants
INTERVENTIONAL
2015-01-31
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SVD-tailored Integrative Psychotherapy (IPT)
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.
SVD-tailored Integrative Psychotherapy (IPT)
(see description of corresponding study arm)
Self-help group (SHG)
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.
Self-help group (SHG)
(see description of corresponding study arm)
Interventions
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SVD-tailored Integrative Psychotherapy (IPT)
(see description of corresponding study arm)
Self-help group (SHG)
(see description of corresponding study arm)
Eligibility Criteria
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Inclusion Criteria
* Clinically relevant SVD (VHQ sum score \> 45)
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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German Center for Vertigo and Balance Disorders
OTHER
Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Claas Lahmann, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich
Central Contacts
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Gabriele Schmid, Dr. phil. Dipl.-Psych.
Role: CONTACT
Phone: +49 (0)89 4140 4398
Email: [email protected]
References
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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.
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.
Other Identifiers
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01EO1401
Identifier Type: -
Identifier Source: org_study_id