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NCT Number: NCT03983291

FaReWell Depression - Facial Exercise Program to Treat Depression

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentrum für Angst- und Depressionsbehandlung

Zurich, 8008, Switzerland

Location status: Recruiting

Location contact

Patricia Waldvogel, PhD

CONTACT

[email protected]

+41 44 3866600

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FaReWell Depression

Behavioral

Facial massage and force exercise

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Wollmer, MD

CONTACT

[email protected]

+49 151 53136738

Patricia Waldvogel, PhD

CONTACT

[email protected]

+41 44 3866600

Sponsors and collaborators

Lead sponsor

Zentrum für Angst und Depressionsbehandlung Zürich

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2019
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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