IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)

NCT02176226 | Completed Results DMC

• 2 other identifiers: R01MH100482-01-FTICR01MH100482-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Anxiety Disorders

Keywords

Major Depressive Disorder; Anxiety Disorders; Behavior Therapy; Technology Assisted; Mobile Phone; Cellular Phone; Smartphone; App

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Mean Number of Treatment App Use Sessions by Study Week

  Weekly for Two Months

Study Arms (1)

8-Week Single Arm Field Trial

EXPERIMENTAL

Use of IntelliCare program for 8 weeks.

Behavioral: IntelliCare

Interventions

IntelliCare BEHAVIORAL

Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.

8-Week Single Arm Field Trial

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Rubanovich CK, Mohr DC, Schueller SM. Health App Use Among Individuals With Symptoms of Depression and Anxiety: A Survey Study With Thematic Coding. JMIR Ment Health. 2017 Jun 23;4(2):e22. doi: 10.2196/mental.7603.

  PMID: 28645891 DERIVED

• Mohr DC, Tomasino KN, Lattie EG, Palac HL, Kwasny MJ, Weingardt K, Karr CJ, Kaiser SM, Rossom RC, Bardsley LR, Caccamo L, Stiles-Shields C, Schueller SM. IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. J Med Internet Res. 2017 Jan 5;19(1):e10. doi: 10.2196/jmir.6645.

  PMID: 28057609 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Results Point of Contact

• Title: David C. Mohr, PhD
• Organization: Northwestern University

d-mohr@northwestern.edu

312-503-1403

Study Officials

• David C Mohr, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 26, 2023
• Results First Posted: October 29, 2018

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)