Major Depressive Disorder Clinical Trial
Official title:
Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
NCT number | NCT02176226 |
Other study ID # | R01MH100482-01FTIC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | June 2016 |
Verified date | March 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate a Smartphone intervention for depression and anxiety that uses machine learning to tailor treatment for patients. The intervention, referred to as IntelliCare, delivers patient-specific treatment material and motivational messaging via a mobile phone, to help individuals with depression and/or anxiety. Information and data received from the patient will inform the tailored treatment approach through machine learning. The purpose of this study is to obtain preliminary information on the feasibility and effectiveness of IntelliCare in improving symptoms of depression and anxiety.
Status | Completed |
Enrollment | 105 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Meets criteria for clinically significant symptoms of depression or anxiety using self-report measures used in screening for depression, as well as interviewer administered measures to ensure symptoms are not transitory and have been present for at least two weeks. - Is familiar with the use of mobile phones - Has an Android phone and is willing download the IntelliCare apps on their own device - Is able to speak and read English - Is at least 19 years of age - Is able to give informed consent Exclusion Criteria: - Has visual, hearing, voice, or motor impairment that would prevent completion of study and treatment procedures - Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, obsessive compulsive disorder, severe post traumatic stress disorder, etc.). - Exhibits severe suicidality, including ideation, plan, and intent. - Currently receiving psychotherapy or planning to receive psychotherapy during the 8 weeks of the study. - Participants who have been on an antidepressant or anxiolytic medication with no dose changes for 2 weeks and do not intend to change the dose will be eligible. Those who have been on the antidepressant or anxiolytic for less than 2 weeks or intend to have their medication optimized will be asked to wait for screening until they meet the 2-week criterion. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module | The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe. | Baseline, Week 4, and Week 8 | |
Primary | GAD-7 (Generalized Anxiety Disorder Scale-7) | The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms. | Baseline, Week 4, and Week 8 | |
Secondary | Mean Number of Treatment App Use Sessions by Study Week | Weekly for Two Months |
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