Impact of Online or In-person Cognitive Behavioural Psychotherapy Interventions on Anxiety and Depression Symptoms in Caregivers of Patients with Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-9 for the assessment of depression symptomatology
研究概览
简要总结
Oncological diseases are considered a family disease because when one member is diagnosed with cancer, the psycho-physical, social and economic consequences affect the entire family. In Italy, approximately 17% of the population assists a family member. These caregivers are typically unpaid individuals such as partners, offspring, and relatives who provide daily support. In Italy, the prevalence of depressive disorders among caregivers of patients with cancer ranges between 40%-70%. Therefore, providing psychological support to patients and their caregivers throughout the illness and beyond is essential. This support should include the assistance of psychologists and psychotherapists experienced in coping with illness and grieving. Cognitive Behavioral Therapy (CBT) refers to a series of interventions aimed at treating psychological disorders by modifying dysfunctional cognitive factors that sustain and exacerbate this condition. In the telemedicine setting, psychological teleconsultation is experiencing extensive development, especially in the home setting for chronic illnesses. According to the scientific literature, much evidence suggests no difference in the effectiveness of psychological therapies provided telematically or in-person.
This study aims to evaluate the impact of CBT online or in-person intervention on anxiety and depression symptoms. The intervention is designed for caregivers of patients with cancer assisted at home. The sample population consists of caregivers of patients assisted by the oncological palliative home care programme of ANT Foundation and caregivers grieving for a loved one previously assisted by ANT Foundation.
Participants meeting the inclusion criteria will be randomised into two groups:
Online group: caregivers will receive an intervention of 10-12 psychological sessions in the online setting.
In-person group: caregivers will receive the same CBT intervention lasting 10-12 psychological sessions, in-person.
We are expecting:
- Reduction in anxiety symptoms measured by comparison of the results obtained at T0 and T1 of the Generalized Anxiety Disorder Scale-7 (GAD-7) questionnaire
- Reduction in depressive symptoms measured by comparing the results obtained at T0 and T1 of the Patient Health Questionnaire-9 (PHQ-9) questionnaire.
详细描述
Background Oncological diseases are considered a family disease because when one member is diagnosed with cancer, the psycho-physical, social and economic consequences affect the entire family. In Italy, approximately 17% of the population assists a family member. These caregivers are typically unpaid individuals such as partners, offspring, relatives who provide daily support. In Italy, the prevalence of depressive disorders among caregivers of patients with cancer ranges from 40% to 70%. Providing psychological support to patients and their caregivers throughout the course of the illness, including post-bereavement, is essential This support should include the assistance of psychologists and psychotherapists experienced in coping with illness and grieving.
Cognitive Behavioral Therapy (CBT) refers to a series of interventions aimed at treating psychological disorders by modifying dysfunctional cognitive factors that sustain and exacerbate this condition. In the telemedicine setting, psychological teleconsultation is experiencing extensive development, especially in the home setting for chronic illnesses. Web-based psychological interventions have been proven effective in reducing anxiety and depression symptoms and in improving the quality of life among various patient populations and their relatives. The clinical outcomes are also comparable to psychological interventions delivered in-person. Finally, a great deal of evidence suggests that there is no difference in the effectiveness of psychological therapies provided online or in-person.
Aim of the study The study aims to evaluate the impact of a CBT intervention conducted online or in-person on anxiety and depression symptoms. The intervention is designed for caregivers of patients with cancer assisted at home and for caregivers grieving for a loved one previously assisted at home.
Primary aim
- Evaluation of the impact of a CBT intervention conducted online or in-person on anxiety and depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of anxious-depressive symptomatology, included in the cut-off 5-21 of the Generalized Anxiety Disorder Scale-7 (GAD-7) and/or in the cut-off 5-27 of the Patient Health Questionnaire-9 (PHQ-9).
- •Aged 18 years or older.
- •Able to understand the aims of the study and to sign the informed consent.
- •Able to understand the Italian language.
- •Able to use a technological tool for tele-consultations (smartphone, tablet, computer, etc.).
排除标准
- •With severe psychiatric pathology causing clinically significant impairment of functioning in social, occupational or other important areas.
- •With cognitive impairment.
- •Engaged in psychological support/psychotherapy within the last 3 months.
- •Who does not meet the inclusion criteria.
结局指标
主要结局
Patient Health Questionnaire-9 for the assessment of depression symptomatology
时间窗: The questionnaire will be filled out by the participant at the time of recruitment (baseline, T0) and at the end of the intervention (T1, week 13).
The Patient Health Questionnaire - 9 is the major depressive disorder module of the full questionnaire. This scale is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. The scores of the 9 questions range from "0" (not at all) to "3" (nearly every day), providing a 0-27 severity total score. The last item ("How difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?") is not included in score, but is a good indicator of the patient's global impairment and can be used to track treatment response. Higher questionnaire scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization.
Generalized Anxiety Disorder Scale-7 for the assessment of anxiety symptomatology.
时间窗: The questionnaire will be filled out by the participant at the time of recruitment (baseline, T0) and at the end of the intervention (T1, week 13).
The General Anxiety Disorder-7 is a rapid screening for the presence of a clinically significant anxiety disorder, especially in outpatient settings. The questionnaire consists of 7 questions and reflects the frequency of symptoms during the preceding 2-week period. The questionnaire requires approximately 1-2 minutes to administer and for each symptom queried provides the following response options: "not at all," "several days," "over half the days" and "nearly every day" and these are scored, respectively, as 0, 1, 2 or 3, providing a 0-21 severity total score. Higher questionnaire scores correlate with disability and functional impairment (in measures such as work productivity and health care utilization).
次要结局
未报告次要终点