FaReWell Depression - Facial Exercise Program to Treat Depression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: FaReWell Depression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For six weeks one arm receives the FaReWell Depression intervention and one arm receives a control resting intervention. The former arm continues on the FaReWell Depression intervention while the latter arm is switched to the FaReWell Depression intervention for another six weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FaReWell Depression<br>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 | Behavioral: FaReWell Depression<br>* Facial massage and force exercise<br>|
| Placebo Comparator: Resting exercise<br>Resting 15 minutes daily | Behavioral: FaReWell Depression<br>* Facial massage and force exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |