Depression Anxiety DisorderGINEMOTIONNCT06884033
Cinematherapy for Women With Depression and Anxiety
A study testing Cinematherapy in people with Depression Anxiety Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Group cinematherapy program in reducing depressive and anxiety symptoms in women diagnosed with Depressive Disorders and Anxiety Disorders. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Depression Anxiety Disorder
- What is being tested?
- Cinematherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression Anxiety Disorder
- Being tested
- Cinematherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinematherapyBehavioural
Cinematherapy, also known as cinema therapy and movie therapy, involves therapist-directed viewing of movies for specific therapeutic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Cinematherapy intervention | Experimental | Cinematherapy intervention Receives: Behavioral: Cinematherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 months
Secondary outcomes (4)
Weight will be collected for all patients.
Weight in kilograms will be collected for all patients.
Measured: 8 months
Eight will be collected for all patients.
Height in metres will be collected for all patients.
Measured: 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.
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Jan 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna Mazza, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884033
- Sponsor's protocol ID
- 7075
- Acronym
- GINEMOTION
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GINEMOTION: Cinematherapy for Women With Depression and Anxiety
- ClinicalTrials.gov ID
- NCT06884033
- Acronym / sponsor ID
- GINEMOTION / 7075
- Conditions
- Depression Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinematherapy intervention | Experimental | Behavioral: CinematherapyCinematherapy intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinematherapyCinematherapy, also known as cinema therapy and movie therapy, involves therapist-directed viewing of movies for specific therapeutic purposes. | Behavioural | Cinematherapy intervention |
Primary outcome
Assessment of change from baseline in anxiety symptoms.
Time frame: 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.
Time frame: 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.
4 secondary outcomes
Weight will be collected for all patients.
Time frame: 8 months
Eight will be collected for all patients.
Time frame: 8 months
Body mass index (BMI) will be collected for all patients.
Time frame: 8 months
Heart rate variability (HRV) will be collected for all patients.
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna Mazza principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinematherapy in people with Depression Anxiety Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change from baseline in anxiety symptoms. (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.