Online or In-person Interventions on Anxiety and Depression Symptoms in Caregivers of Patients with Cancer

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.

NCT Number	NCT06592573
Lead Sponsor	Fondazione ANT Franco Pannuti ETS
Conditions	Anxiety, Depressive Symptoms
Enrollment	50 participants
Start Date	2024-02-01
Primary Completion	2025-09-30 (estimated)
Study Completion	2026-01-31 (estimated)
Updated on ClinicalTrials.gov	2024-09-19