Training to improve heart rate variability in patients with psychogenic disorders
Evaluation of the Effectiveness of a Heart Rate Variability Biofeedback Training in the Management of Dysfunctional (Somatoform) Disorders
This study is testing if heart rate variability training can help people with psychogenic cervical dystonia feel better by reducing their symptoms and improving their mental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04777825 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Heart Rate Variability (HRV) biofeedback training in patients diagnosed with psychogenic cervical dystonia, who are not candidates for surgery. Over a six-month period, participants will undergo 12 sessions of HRV biofeedback aimed at enhancing their self-regulatory skills and reducing symptoms such as abnormal head posture and pain. The intervention is designed to address the psychological aspects of their condition, potentially improving anxiety, depression, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who exhibit symptoms of psychogenic cervical dystonia and have been diagnosed with a somatoform disorder.
Not a fit: Patients with organic causes for their cervical dystonia or those who do not meet the criteria for psychogenic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and non-pharmacological treatment option for patients suffering from psychogenic disorders.
How similar studies have performed: While HRV biofeedback is a relatively novel approach in this specific context, similar interventions have shown promise in managing other psychogenic and functional disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age 18 to 75 * Responding to somatoform disorder characteristics as described in ICD-10 (F45: "The onset of physical symptoms associated with an insistent medical quest, persisting despite repeated negative assessments and statements by physicians that the symptoms have no organic basis. If there is a genuine physical disorder, it does not account for the nature or severity of the symptoms, or the distress or concerns of the subject. The multidisciplinary team will determine whether or not the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) \[ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"\] is associated with the diagnosis of conversion disorder (disorder with functional neurological symptoms) of the DSMV (300.11) \[ICD-10 equivalent: F44.4 "dissociative disorder with abnormal movements"\], selected by the multidisciplinary team after a phase 1 assessment. * Patient benefiting from a social security scheme Exclusion criteria: * Simulation identified with obvious search for secondary benefit according to the ICD-10 classification ( Z76.5 Simulator: Person pretending to be ill (with obvious motivation"), or DSM-V(V65.2) * Any other specific PAT-specific CEP (botulinum toxin, psychotherapy and/or relaxation provided by a professional (CBT, ACT, Mindfulness, etc.)) scheduled within 6 months, with the exception of the usual analgesics (Tier I or II)Presenting significant cognitive impairment (MoCa test ≤ 24/30), * Absence foreseeable at least 30% of the sessions, * Lack of informed consent. * Pregnancy or planned pregnancy during the study period, Pregnant or breastfeeding women * Major protected by law or patient under guardianship or curatorship * Participation in other ongoing research
Where this trial is running
Montpellier
- Montpellier University Hospital — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Philippe COUBES, MD, PhD — Montpellier University Hospital
- Study coordinator: Emily SANREY, MSc
- Email: e-sanrey@chu-montpellier.fr
- Phone: 467337445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.