FaReWell Depression - Facial Exercise Program to Treat Depression

NCT ID: NCT03983291

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2025-12-01

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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

FaReWell Depression

Intervention Type BEHAVIORAL

Facial massage and force exercise

Resting exercise

Resting 15 minutes daily

Group Type PLACEBO_COMPARATOR

FaReWell Depression

Intervention Type BEHAVIORAL

Facial massage and force exercise

Interventions

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FaReWell Depression

Facial massage and force exercise

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zentrum für Angst und Depressionsbehandlung Zürich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Waldvogel, PhD

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Angst und Depressionsbehandlung Zürich

Locations

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Zentrum für Angst- und Depressionsbehandlung

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Patricia Waldvogel, PhD

Role: CONTACT

+41 44 3866600

Axel Wollmer, MD

Role: CONTACT

+49 151 53136738

Facility Contacts

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Patricia Waldvogel, PhD

Role: primary

+41 44 3866600

Other Identifiers

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Version 1.1

Identifier Type: -

Identifier Source: org_study_id

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