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FaReWell Depression - Facial Exercise Program to Treat Depression

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ClinicalTrials.gov Identifier: NCT03983291
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Zentrum für Angst und Depressionsbehandlung Zürich

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: FaReWell Depression Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facial Rehabilitation of Wellbeing in Depression: a Randomized Controled Trial of a Facial Physiotherapeutic Exercise Program in the Treatment of Depression
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Behavioral: FaReWell Depression
Facial massage and force exercise

Placebo Comparator: Resting exercise
Resting 15 minutes daily
Behavioral: FaReWell Depression
Facial massage and force exercise




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983291


Contacts
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Contact: Patricia Waldvogel, PhD +41 44 3866600 PWaldvogel@zadz.ch
Contact: Axel Wollmer, MD +49 151 53136738 axel.wollmer@unibas.ch

Locations
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Switzerland
Zentrum für Angst- und Depressionsbehandlung Recruiting
Zürich, Switzerland, 8008
Contact: Patricia Waldvogel, PhD    +41 44 3866600    PWaldvogel@zadz.ch   
Sponsors and Collaborators
Zentrum für Angst und Depressionsbehandlung Zürich
Investigators
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Principal Investigator: Patricia Waldvogel, PhD Zentrum für Angst und Depressionsbehandlung Zürich

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Responsible Party: Zentrum für Angst und Depressionsbehandlung Zürich
ClinicalTrials.gov Identifier: NCT03983291     History of Changes
Other Study ID Numbers: Version 1.1
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders