search
Back to results

FaReWell Depression - Facial Exercise Program to Treat Depression

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FaReWell Depression
Sponsored by
Zentrum für Angst und Depressionsbehandlung Zürich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zentrum für Angst- und DepressionsbehandlungRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FaReWell Depression

Resting exercise

Arm Description

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

Resting 15 minutes daily

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
June 10, 2019
Last Updated
July 31, 2023
Sponsor
Zentrum für Angst und Depressionsbehandlung Zürich
search

1. Study Identification

Unique Protocol Identification Number
NCT03983291
Brief Title
FaReWell Depression - Facial Exercise Program to Treat Depression
Official Title
Facial Rehabilitation of Wellbeing in Depression: a Randomized Controled Trial of a Facial Physiotherapeutic Exercise Program in the Treatment of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zentrum für Angst und Depressionsbehandlung Zürich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FaReWell Depression
Arm Type
Experimental
Arm Description
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
Arm Title
Resting exercise
Arm Type
Placebo Comparator
Arm Description
Resting 15 minutes daily
Intervention Type
Behavioral
Intervention Name(s)
FaReWell Depression
Intervention Description
Facial massage and force exercise
Primary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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).
Time Frame
3, 9, 12 weeks
Title
Change in Patient-Health-Questionnaire-9 (PHQ-9)
Description
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).
Time Frame
3, 6, 9, 12 weeks
Title
Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D)
Description
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).
Time Frame
3, 6, 9, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Waldvogel, PhD
Phone
+41 44 3866600
Email
PWaldvogel@zadz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Wollmer, MD
Phone
+49 151 53136738
Email
axel.wollmer@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Waldvogel, PhD
Organizational Affiliation
Zentrum für Angst und Depressionsbehandlung Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Angst- und Depressionsbehandlung
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Waldvogel, PhD
Phone
+41 44 3866600
Email
PWaldvogel@zadz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

FaReWell Depression - Facial Exercise Program to Treat Depression

We'll reach out to this number within 24 hrs