FaReWell Depression – Facial Exercise Program to Treat Depression

Overview

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.

Full Title of Study: “Facial Rehabilitation of Wellbeing in Depression: a Randomized Controled Trial of a Facial Physiotherapeutic Exercise Program in the Treatment of Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 15, 2020

Detailed 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.

Interventions

  • Behavioral: FaReWell Depression
    • Facial massage and force exercise

Arms, Groups and Cohorts

  • Experimental: FaReWell Depression
    • Physiotherapeutic exercises for the relaxation of facial muscles associated with the expression of negative emotions and for the activation and strengthening of facial muscles associated with the expression of positive emotions 15 minutes daily
  • Placebo Comparator: Resting exercise
    • Resting 15 minutes daily

Clinical Trial Outcome Measures

Primary Measures

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)
    • Time Frame: 6 weeks
    • 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).

Secondary Measures

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS)
    • Time Frame: 3, 9, 12 weeks
    • 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).
  • Change in Patient-Health-Questionnaire-9 (PHQ-9)
    • Time Frame: 3, 6, 9, 12 weeks
    • 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).
  • Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D)
    • Time Frame: 3, 6, 9, 12 weeks
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zentrum für Angst und Depressionsbehandlung Zürich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patricia Waldvogel, PhD, Principal Investigator, Zentrum für Angst und Depressionsbehandlung Zürich
  • Overall Contact(s)
    • Patricia Waldvogel, PhD, +41 44 3866600, PWaldvogel@zadz.ch

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