{
    "info": {
        "nct_id": "NCT04583891",
        "official_title": "Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design",
        "inclusion_criteria": "1. age ≥ 18 years (age 19 if in Nebraska, given age of consent);\n2. 0-5 years post-diagnosis of Stage I, II, or III female breast cancer;\n3. elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10 and/or symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks;\n2. mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care;\n3. do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later);\n4. cannot read and speak English (current intervention only available in English).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. age ≥ 18 years (age 19 if in Nebraska, given age of consent);",
            "criterions": [
                {
                    "exact_snippets": "age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "age 19 if in Nebraska",
                    "criterion": "age in Nebraska",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. 0-5 years post-diagnosis of Stage I, II, or III female breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "0-5 years post-diagnosis",
                    "criterion": "time since diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I, II, or III female breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage I",
                                "Stage II",
                                "Stage III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "female breast cancer",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Taking antidepressant medication",
                    "criterion": "antidepressant medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have had an appointment to adjust the dosage over the past 2 weeks",
                    "criterion": "appointment to adjust antidepressant dosage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care;",
            "criterions": [
                {
                    "exact_snippets": "mental health condition deemed to interfere with study procedures or put the participant at undue risk",
                    "criterion": "mental health condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with study procedures",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk to participant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "self-reported history of psychosis",
                    "criterion": "history of psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "self-reported history of ... bipolar disorder",
                    "criterion": "history of bipolar disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active suicidal ideation that necessitates more intense care",
                    "criterion": "active suicidal ideation",
                    "requirements": [
                        {
                            "requirement_type": "necessity for more intense care",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later);",
            "criterions": [
                {
                    "exact_snippets": "do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later)",
                    "criterion": "app-compatible phone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. cannot read and speak English (current intervention only available in English).",
            "criterions": [
                {
                    "exact_snippets": "cannot read and speak English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "3. elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10 and/or symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8.",
            "criterions": [
                {
                    "exact_snippets": "elevated symptoms of depression ... PHQ-8 score ≥ 10",
                    "criterion": "depression symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "PHQ-8 score"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptoms of anxiety ... GAD-7 score ≥ 8",
                    "criterion": "anxiety symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "GAD-7 score"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}