Cinematherapy for Women With Depression and Anxiety (GINEMOTION)

GINEMOTION: Cinematherapy for Women With Depression and Anxiety

Group cinematherapy program in reducing depressive and anxiety symptoms in women diagnosed with Depressive Disorders and Anxiety Disorders.

Study Overview

• Status: Completed
• Conditions: Depression Anxiety Disorder
• Intervention / Treatment: Behavioral: Cinematherapy

Detailed Description

Cinematherapy is a creative therapeutic intervention in which a trained professional prescribes the patient to watch a film and uses the characters and themes as metaphors to promote self-exploration and change. The effectiveness of cinematherapy as a therapeutic technique has been demonstrated through its effectiveness in improving participants' self-esteem, emotional expression and understanding, and interpersonal relationships, and in reducing depressive and anxious symptoms.The cinematherapy intervention involves a targeted selection of film content and activities designed to improve the patients' mental condition.The study includes eight meetings on a monthly basis (programming of eight films lasting approximately two hours and subsequent discussion on the contents of the film shown).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma
    • Rome, Roma, Italy, 00168
      • Marianna Mazza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• female, aged 18-75 years;
• Diagnosis of Depressive Disorders (unipolar and bipolar) and Anxiety Disorders according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5), both new onset in subjects without a previous psychiatric history, and depressive and anxious recurrences;
• Taking psychopharmacological therapy;
• Fluent knowledge of the Italian language;
• Release of a written informed consent, signed by the patient or legal representative and partner.

Exclusion Criteria:

• Diagnosis of Schizophrenia or other psychotic spectrum disorders;
• Diagnosis of neurological disorders associated with cognitive decline;
• Current abuse of alcohol and psychotropic substances, with the exception of smoking;
• Refusal to sign the informed consent to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cinematherapy intervention	Behavioral: Cinematherapy; Cinematherapy, also known as cinema therapy and movie therapy, involves therapist-directed viewing of movies for specific therapeutic purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change from baseline in anxiety symptoms.	The presence and degree of anxiety will be assessed using the Hamilton Anxiety Rating Scale (HARS). The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.	8 months
Assessment of change from baseline in depression symptoms.	The presence and degree of depression will be assessed using the Hamilton Depression Rating Scale (HDRS). The scale contains 17 items pertaining to symptoms of depression experienced over the past week. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight will be collected for all patients.	Weight in kilograms will be collected for all patients.	8 months
Eight will be collected for all patients.	Height in metres will be collected for all patients.	8 months
Body mass index (BMI) will be collected for all patients.	Body mass index, or BMI, gives an indication of body size. BMI is calculated using weight and height (weight in kilograms divided by height in metres squared).The formula is BMI = kg/m2; kg is a person's weight in kilograms and m2 is height in metres squared. BMI can help estimate risk of a heart attack or stroke.	8 months
Heart rate variability (HRV) will be collected for all patients.	HRV is a measure of the variation in time between each heartbeat in electrocardiogram . It is used as a reliable, noninvasive method of measuring physiological responses to stress. A consistent baseline score of 70 or higher is associated with health; whereas levels between 50 and 70 are compromised health and diseases; whereas a regular HRV below 50 puts the person at risk for catastrophic illness and even death.	8 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Marianna Mazza, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 7075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No