Clinical trial NCT03983291: 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
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Zentrum für Angst und Depressionsbehandlung Zürich
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 3, 9, 12 weeks
measure: Change in Patient-Health-Questionnaire-9 (PHQ-9)
timeFrame: 3, 6, 9, 12 weeks
measure: Change in Snaith-Hamilton-Pleasure-Scale (SHAPS-D)
timeFrame: 3, 6, 9, 12 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Zentrum für Angst- und Depressionsbehandlung
Study officials:
affiliation: Zentrum für Angst und Depressionsbehandlung Zürich
name: Patricia Waldvogel, PhD
role: PRINCIPAL_INVESTIGATOR
References: