G25.81
Conditions
Interventions
Group 1: active-awake hypnosis
Group 2: behavioral therapy
Group 3: routine care
Sponsors
Charité – Universitätsmedizin Berlin Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Charité – Universitätsmedizin Berlin Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Age between 18 years and 70 years - Presence of a medically confirmed diagnosis of RLS - At least moderate to severe RLS symptoms (IRLS total score = 16) using the International Restless Legs Syn-drome Study Group's (IRLS) severity scale - No change in baseline RLS medication in the last 4 weeks prior to inclusion - No planned and foreseeable change/start of RLS medication during the study period - No use of RLS medication and no desire to start RLS medication during the course of the study - Willingness to be randomized and to participate in the study investigations - Willingness to complete questionnaires and diaries - Able to give informed consent and cognitively and linguistically capable of assessing the significance of the study - Availability of a signed declaration of consent.
Exclusion criteria
Exclusion criteria: -Known polyneuropathies -Known symptomatic spinal canal stenosis -Use of RLS-triggering medications (such as typical neuroleptics, beta-blockers, antiemetics, antidepressants including selective serotonin reuptake inhibitors, mirtazapine, amitriptyline) -History of iron deficiency and planned intravenous iron supplementation during the study -Known presence of severe acute and/or chronic organic or psychological disorders (particularly a history of severe trauma leading to post-traumatic stress disorder, current or past psychotic disorders, acute self-harm, or suicidality) -Use of opioids -Use of hypnosis or behavioral therapy to alleviate RLS symptoms within the last 8 weeks before enrollment or planned during the study -Use of other complementary medical therapies recommended in the German guidelines for reducing RLS symptoms during the study -Participation in another interventional study on the same condition during the study period or within the last 3 months prior to study start -Dependence on the study center/study management (e.g., employees) -Pregnancy or breastfeeding -Ongoing application for disability pension or intention to apply for one
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restless Legs Syndrome Study Group Rating Scale for Severity of Restless Legs Syndrome (IRLS) after week 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Perceived Stress Scale (PSS), RLS-Qol , PSQI, PGI-C after week 12 and 24 | — |
Countries
Germany
Contacts
Public ContactBenno Brinkhaus
Charité – Universitätsmedizin Berlin Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Charité – Universitätsmedizin Berlin Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Outcome results
None listed