Cinematherapy for Women With Depression and Anxiety

Not Applicable

Not yet recruiting

• Conditions: Depression Anxiety Disorder

• Registration Number: NCT06884033
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study Start: 2025-03-15
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of change from baseline in anxiety symptoms.	8 months	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.
Assessment of change from baseline in depression symptoms.	8 months	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.

Secondary Outcome Measures

Name	Time	Method
Weight will be collected for all patients.	8 months	Weight in kilograms will be collected for all patients.
Eight will be collected for all patients.	8 months	Height in metres will be collected for all patients.
Body mass index (BMI) will be collected for all patients.	8 months	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.
Heart rate variability (HRV) will be collected for all patients.	8 months	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.