{
    "info": {
        "nct_id": "NCT06592573",
        "official_title": "Impact of Online or In-person Cognitive Behavioural Psychotherapy Interventions on Anxiety and Depression Symptoms in Caregivers of Patients with Cancer",
        "inclusion_criteria": "* 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).\n* Aged 18 years or older.\n* Able to understand the aims of the study and to sign the informed consent.\n* Able to understand the Italian language.\n* Able to use a technological tool for tele-consultations (smartphone, tablet, computer, etc.).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* With severe psychiatric pathology causing clinically significant impairment of functioning in social, occupational or other important areas.\n* With cognitive impairment.\n* Engaged in psychological support/psychotherapy within the last 3 months.\n* Who does not meet the inclusion criteria.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 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).",
            "criterions": [
                {
                    "exact_snippets": "Presence of anxious-depressive symptomatology",
                    "criterion": "anxious-depressive symptomatology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cut-off 5-21 of the Generalized Anxiety Disorder Scale-7 (GAD-7)",
                    "criterion": "Generalized Anxiety Disorder Scale-7 (GAD-7) score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 21,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cut-off 5-27 of the Patient Health Questionnaire-9 (PHQ-9)",
                    "criterion": "Patient Health Questionnaire-9 (PHQ-9) score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 27,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to understand the Italian language.",
            "criterions": [
                {
                    "exact_snippets": "Able to understand the Italian language.",
                    "criterion": "language comprehension",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "Italian"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to use a technological tool for tele-consultations (smartphone, tablet, computer, etc.).",
            "criterions": [
                {
                    "exact_snippets": "Able to use a technological tool for tele-consultations (smartphone, tablet, computer, etc.)",
                    "criterion": "use of technological tool for tele-consultations",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* With severe psychiatric pathology causing clinically significant impairment of functioning in social, occupational or other important areas.",
            "criterions": [
                {
                    "exact_snippets": "severe psychiatric pathology",
                    "criterion": "psychiatric pathology",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant impairment of functioning in social, occupational or other important areas",
                    "criterion": "impairment of functioning",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "areas affected",
                            "expected_value": [
                                "social",
                                "occupational",
                                "other important areas"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With cognitive impairment.",
            "criterions": [
                {
                    "exact_snippets": "cognitive impairment",
                    "criterion": "cognitive impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Engaged in psychological support/psychotherapy within the last 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Engaged in psychological support/psychotherapy within the last 3 months.",
                    "criterion": "psychological support/psychotherapy",
                    "requirements": [
                        {
                            "requirement_type": "engagement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Who does not meet the inclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "does not meet the inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Able to understand the aims of the study and to sign the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to understand the aims of the study",
                    "criterion": "understanding of study aims",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able ... to sign the informed consent",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}