GINEMOTION: Cinematherapy for Women With Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of change from baseline in anxiety symptoms.
研究概览
简要总结
Group cinematherapy program in reducing depressive and anxiety symptoms in women diagnosed with Depressive Disorders and Anxiety Disorders.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of change from baseline in anxiety symptoms.
时间窗: 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.
时间窗: 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.
次要结局
- 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)