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Recruiting NCT03983291

FaReWell Depression - Facial Exercise Program to Treat Depression

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FaReWell Depression.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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

Primary outcome measures

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: 6 weeks]
Secondary outcome measures (3)
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: 3, 9, 12 weeks]
  • Change in Patient-Health-Questionnaire-9 (PHQ-9) [Time frame: 3, 6, 9, 12 weeks]
  • Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D) [Time frame: 3, 6, 9, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Zentrum für Angst- und Depressionsbehandlung — Zurich

Identifiers

NCT: NCT03983291 · Version 1.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗