Tailored Care for Somatoform Vertigo/Dizziness

Technical University of Munich

Status: Unknown

Conditions: Somatoform Vertigo/Dizziness

Treatments: Behavioral: Self-help group (SHG); Behavioral: SVD-tailored Integrative Psychotherapy (IPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02320851

01EO1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

SVD-tailored Integrative Psychotherapy (IPT)

Experimental group

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.

Treatment:

Behavioral: SVD-tailored Integrative Psychotherapy (IPT)

Self-help group (SHG)

Active Comparator group

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.

Treatment:

Behavioral: Self-help group (SHG)