FaReWell Depression - Facial Exercise Program to Treat Depression

Depression Clinical Trial

Official title:

Facial Rehabilitation of Wellbeing in Depression: a Randomized Controled Trial of a Facial Physiotherapeutic Exercise Program in the Treatment of Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983291
• Other study ID #: Version 1.1
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Zentrum für Angst und Depressionsbehandlung Zürich
• Contact: Patricia Waldvogel, PhD
• Phone: +41 44 3866600
• Email: PWaldvogel[@]zadz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates if a physiotherapeutic exercise program designed to relax facial muscles associated with the expression of negative emotions and to activate and strengthen facial muscles associated with the expression of positive emotions can reduce the symptoms of depression and improve wellbeing and quality of life in the affected patients.

Description:

Activity of the facial musculature expresses emotions, but also generates proprioceptive signals to the emotional brain that maintain and reinforce the expressed emotions. This has been described by Charles Darwin and William James in the facial feedback hypothesis.

Studies have shown that interruption of facial feedback by the injection of botulinum toxin into the corrugator and procerus muscles, which express negative emotions like sadness, anger, and fear, can reduce the symptoms of depression.

In the present study we investigate, if similar effects can be achieved by a relaxing massage of these and other muscles that are associated with the expression of negative emotions and if strengthening exercises of muscles that express positive emotions, the zygomaticus and orbicularis oculi muscles, can contribute to the rehabilitation of positive emotionality in depression. After instruction by a physiotherapist, participants will practice the exercises daily for 15 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Mild to moderate unipolar depression

• Stable treatment for at least 6 weeks

Exclusion Criteria:

• Organic mental disorders

• Mental disorders due to psychoactive substance use

• Schizophrenia and other psychotic disorders

• Previous cosmetic procedures (botulinum toxin, fillers, lifting)

• Facial palsy

• Facial skin disorders

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• FaReWell Depression
Facial massage and force exercise

Locations

Country	Name	City	State
Switzerland	Zentrum für Angst- und Depressionsbehandlung	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Zentrum für Angst und Depressionsbehandlung Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)	The Montgomery-Asberg Depression Rating Scale (MADRS) is an expert rating scale with 10 items for the measurement of the severity of depressive symptoms. Change in depression severity is measured as change in the total score of the scale (0-60 points).	6 weeks
Secondary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)	The Montgomery-Asberg Depression Rating Scale (MADRS) is an expert rating scale with 10 items for the measurement of the severity of depressive symptoms. Change in depression severity is measured as change in the total score of the scale (0-60 points).	3, 9, 12 weeks
Secondary	Change in Patient-Health-Questionnaire-9 (PHQ-9)	The Patient-Health-Questionnaire-9 (PHQ-9) is a self-rating scale with 9 items for the measurement of the severity of depressive symptoms. Change in depression severity is measured as change in the total score of the scale (0-27 points).	3, 6, 9, 12 weeks
Secondary	Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D)	The Snaith-Hamilton-Pleasure-Scale (SHAPS-D) is a self-rating scale with 14 items for the measurement of pleasure. Change in anhedonia (inability to experience pleasure) is measured as change in the total score of the scale (0-14 points).	3, 6, 9, 12 weeks