Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06592573

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.)
Not Eligible

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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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione ANT

Bologna, BO, Italy, 40128

Actively Recruiting

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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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