FaReWell Depression - Facial Exercise Program to Treat Depression

NCT03983291 | Recruiting DMC

• 1 other identifier: Version 1.1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)

  3, 9, 12 weeks

• Change in Patient-Health-Questionnaire-9 (PHQ-9)

  3, 6, 9, 12 weeks

• Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D)

  3, 6, 9, 12 weeks

Study Arms (2)

FaReWell Depression

EXPERIMENTAL

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

Resting exercise

PLACEBO COMPARATOR

Resting 15 minutes daily

Behavioral: FaReWell Depression

Interventions

FaReWell Depression BEHAVIORAL

Facial massage and force exercise

FaReWell Depression; Resting exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate unipolar depression
• Stable treatment for at least 6 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Zentrum für Angst und Depressionsbehandlung Zürich: lead

Study Sites (1)

Zentrum für Angst- und Depressionsbehandlung

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Patricia Waldvogel, PhD

  Zentrum für Angst und Depressionsbehandlung Zürich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Waldvogel, PhD

CONTACT

+41 44 3866600; PWaldvogel@zadz.ch

Axel Wollmer, MD

CONTACT

+49 151 53136738; axel.wollmer@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 1, 2019
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)