Cinematherapy for Women With Depression and Anxiety

NCT06884033 | Completed

• 1 other identifier: 7075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Weight will be collected for all patients.

  8 months

• Eight will be collected for all patients.

  8 months

• Body mass index (BMI) will be collected for all patients.

  8 months

• Heart rate variability (HRV) will be collected for all patients.

  8 months

Study Arms (1)

Cinematherapy intervention

EXPERIMENTAL

Cinematherapy intervention

Behavioral: Cinematherapy

Interventions

Cinematherapy BEHAVIORAL

Cinematherapy, also known as cinema therapy and movie therapy, involves therapist-directed viewing of movies for specific therapeutic purposes.

Cinematherapy intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Marianna Mazza

Rome, ROMA, 00168, Italy

Location

Study Officials

• Marianna Mazza

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 19, 2025
• Study Start: January 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)