Actively Recruiting
Online or In-person Interventions on Anxiety and Depression Symptoms in Caregivers of Patients with Cancer
Led by Fondazione ANT Italia ONLUS · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Online or In-person Interventions on Anxiety and Depression Symptoms in Caregivers of Patients with Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of anxiety or depression symptoms within the cut-off ranges of GAD-7 (5-21) and/or PHQ-9 (5-27)
- Age 18 years or older
- Ability to understand the study aims and provide informed consent
- Ability to understand the Italian language
- Ability to use a technological device for tele-consultations (smartphone, tablet, computer, etc.)
You will not qualify if you...
- Severe psychiatric illness causing significant impairment in social, work, or other important areas
- Cognitive impairment
- Currently engaged in psychological support or psychotherapy within the last 3 months
- Does not meet the inclusion criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione ANT
Bologna, BO, Italy, 40128
Actively Recruiting
Research Team
R
Rita Ostan, PhD
CONTACT
A
Andrea Giannelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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