How Reducing Anxiety in Schizophrenia

NCT02390271 | Completed Phase 4 DMC

• 1 other identifier: m trousselard
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Health care that addresses the emotional regulation capacity of patients with schizophrenia confronted with daily stress may contribute to a less anxious life. A psycho-physiological training (cardiac coherence training; CCT) focusing on emotion regulation is known to decrease anxiety for non-clinical individuals. Methods: the investigators performed a pilot cross sectional survey to explore the benefits of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the program consisting in height to twelve weekly one hour session program during a 2-month follow-up. Standardised questionnaires were used before and after the intervention assessing anxiety, well-being outcomes, and how patients deal with stress and stressors.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)

  outcomes assessed before and after the 3-month Cardiac Coherence Training

  up to two months

Secondary Outcomes (1)

• psychometric outcome: Freiburg Mindfulness Inventory (FMI)

  up to two months

Study Arms (1)

emotion focused therapy training CCT

EXPERIMENTAL

The general training includes in an individual adjusted way the following techniques: biofeedback-assisted breathing classes that erase negative emotion involving the cardiac and limbic neural pathways, control one's own and other's emotions, mastering positive cognition and enhance self-concept, anchoring positive memories, learning how to recognize psychological reversal in others

Other: emotion focused therapy training

Interventions

emotion focused therapy training OTHER

The Cardiac Coherence Training (CCT) incorporates a series of emotion-refocusing and restructuring techniques involving the use of biofeedback to control heart rate variability

Also known as: Cardiac Coherence Training

emotion focused therapy training CCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of remitted schizophrenia

You may not qualify if:

• exacerbation of schizophrenic symptoms over the previous three months (hospitalization or increases in medication)

Sponsors & Collaborators

• Institut de Recherche Biomedicale des Armees: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: June 1, 2011
• Last Updated: March 17, 2015

Record last verified: 2015-03