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

NCT06592573 | Recruiting

• 1 other identifier: 614-2023-OSS-AUSLBO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Anxiety; Depressive Symptoms

Keywords

Online Psychotherapy; Cargivers; Cancer; Grief; Cognitive-Behavioural Therapy

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire-9 for the assessment of depression symptomatology

  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.

  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).

• Generalized Anxiety Disorder Scale-7 for the assessment of anxiety symptomatology.

  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).

  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).

Study Arms (2)

CBT_ONLINE

EXPERIMENTAL

10-12 sessions of cognitive behavioural therapy conducted online.

Other: CBT_ONLINE

CBT_IN PERSON

ACTIVE COMPARATOR

10-12 sessions of cognitive behavioural therapy conducted in-person.

Other: CBT_IN PERSON

Interventions

CBT_ONLINE OTHER

10-12 sessions of cognitive behavioural therapy conducted online

CBT_ONLINE

CBT_IN PERSON OTHER

10-12 sessions of cognitive behavioural therapy conducted in-person.

CBT_IN PERSON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione ANT Italia ONLUS: lead

Study Sites (1)

Fondazione ANT

Bologna, BO, 40128, Italy

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Silvia Varani

  Fondazione ANT Italia ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Ostan, PhD

CONTACT

+390517190153; rita.ostan@ant.it

Andrea Giannelli

CONTACT

andrea.giannelli@ant.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: January 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)