Somatoform Vertigo/DizzinessNCT02320851
Tailored Care for Somatoform Vertigo/Dizziness
A study testing SVD-tailored Integrative Psychotherapy (IPT) and Self-help group (SHG) in people with Somatoform Vertigo/Dizziness, run by Technical University of Munich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatoform Vertigo/Dizziness
- What is being tested?
- SVD-tailored Integrative Psychotherapy (IPT) and Self-help group (SHG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SVD diagnosis
- Clinically relevant SVD (VHQ sum score > 45)
- Informed consent
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
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.
Read the 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.
- Conditions
- Somatoform Vertigo/Dizziness
- Being tested
- SVD-tailored Integrative Psychotherapy (IPT), Self-help group (SHG)
- Keywords
- Somatoform disorder, Functional vertigo/dizziness, Chronic subjective dizziness
- Medical subject headings
- Dizziness, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVD-tailored Integrative Psychotherapy (IPT)Behavioural
(see description of corresponding study arm)
Self-help group (SHG)Behavioural
(see description of corresponding study arm)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-help group (SHG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Improvement at follow-up (12 months after treatment)
Secondary outcomes (6)
Generic quality of life
Generic quality of life will be measured using the Quality of Life Questionnaire (EQ-5D).
Measured: Improvement at follow-up (12 months after treatment)
Severity of vertigo
Severity of vertigo will be measured using the Vertigo Symptom Scale (VSS).
Measured: Improvement at follow-up (12 months after treatment)
Depression
Depression will be measured using the Beck Depression Inventory (BDI-II).
Measured: Improvement at follow-up (12 months after treatment)
Anxiety
Anxiety will be measured using the Beck Anxiety Inventory (BAI).
Measured: Improvement at follow-up (12 months after treatment)
Somatisation
Somatisation will be measured using the Patient Health Questionnaire 15 (PHQ-15).
Measured: Improvement at follow-up (12 months after treatment)
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.
Measured: Improvement at follow-up (12 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Somatoform Vertigo/DizzinessStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Vertigo and Balance Disorders
- Responsible party
- Sponsor
- Investigators
- Claas Lahmann, PD Dr. med., Principal investigator, Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320851
- Sponsor's protocol ID
- 01EO1401
- Status last verified
- Dec 2014
- First submitted
- 16 Dec 2014
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34065517Lahmann 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.
PubMed 26001913
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
- ClinicalTrials.gov ID
- NCT02320851
- Acronym / sponsor ID
- 01EO1401
- Conditions
- Somatoform Vertigo/Dizziness
- Keywords
- Somatoform disorder, Functional vertigo/dizziness, Chronic subjective dizziness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Center for Vertigo and Balance Disorders
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVD-tailored Integrative Psychotherapy (IPT) | Experimental | Behavioral: 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. |
| Self-help group (SHG) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SVD diagnosis
- Clinically relevant SVD (VHQ sum score > 45)
- Informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SVD-tailored Integrative Psychotherapy (IPT)(see description of corresponding study arm) | Behavioural | SVD-tailored Integrative Psychotherapy (IPT) |
| Self-help group (SHG)(see description of corresponding study arm) | Behavioural | Self-help group (SHG) |
Primary outcome
Vertigo-related quality of life
Time frame: Improvement at follow-up (12 months after treatment)
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.
6 secondary outcomes
Generic quality of life
Time frame: Improvement at follow-up (12 months after treatment)
Severity of vertigo
Time frame: Improvement at follow-up (12 months after treatment)
Depression
Time frame: Improvement at follow-up (12 months after treatment)
Anxiety
Time frame: Improvement at follow-up (12 months after treatment)
Somatisation
Time frame: Improvement at follow-up (12 months after treatment)
Computerized Static Posturography and Head Impulse Test
Time frame: Improvement at follow-up (12 months after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
- Derived from this study: PubMed 34065517Limburg 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.
- Derived from this study: PubMed 26001913Lahmann 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claas Lahmann, PD Dr. med. principal investigator
Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich
Questions about this trial
What is this clinical trial studying?
A study testing SVD-tailored Integrative Psychotherapy (IPT) and Self-help group (SHG) in people with Somatoform Vertigo/Dizziness, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Schmid, Dr. phil. Dipl.-Psych. (+49 (0)89 4140 4398, g.schmid@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertigo-related quality of life (time frame: Improvement at follow-up (12 months after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.