A Study to Evaluate the Feasibility of MindLAMP Application to Develop Digitial Phenotypes in Depression

Overview

About this study

The purpose of this study is to assess the feasibility and acceptability of passive data collection with a smartphone in depressed patients and investigate how passive data gathered via technology platforms can generate transdiagnostic digital phenotypes that potentially inform the assessment and/or treatment outcome of major mood disorders. This study aims to assess self-reported, behavioral, cognitive, and physiological data gathered from smartphones and smart watches as compared to gold standard clinical measured in treatment seeking depressed patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Patients:

  • Age 18-65 years.
  • Currently depressed patients [n=100 major depressive disorder (MDD), n=100 bipolar (50 BPI, 50 BII)] confirmed by Mini International Neuropsychiatric Interview (MINI) active in clinical care.
  • Use a compatible smartphone. If participant has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, a smartwatch will be offered for the 12 week trial.

Inclusion Criteria - Healthy Controls:

  • Age 18-65 years old.
  • 100 age- and sex- matched controls as confirmed by Mini International Neuropsychiatric Interview (MINI).
  • Use a compatible smart phone. If participating has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, an accelerometer will be offered for the 12 week trial.

Exclusion Criteria - Patients:

  • Inability to understand written or spoken English.
  • Inability to provide valid written informed consent because of an identified/diagnosed intellectual disability, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
  • Primary reasons for treatment are not related to depression  (e.g., are due to an adjustment disorder, personality disorder  effect of substances or substance abuse, or exacerbation of a comorbid psychiatric disorder) based on available information, review of EHR, and/or investigator judgement.
  • Psychotic disorder or Current psychotic features;
  • Active suicidal ideation (QIDS-C question 12 score of > 2 and investigator judgement).
  • Women with known pregnancy at time of enrollment.*

Exclusion Criteria - Healthy Controls:

  • Inability to understand written or spoken English;
  • Inability to provide valid written informed consent because or mental retardation, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
  • Has had a current  psychiatric diagnosis within the last year.
  • Currently taking a psychotropic medication.
  • Women with known pregnancy at time of enrollment.*

* Healthy controls will not be receiving any psychiatric treatment during the study. For depressed female patients of child bearing potential who will be followed naturalistically, it is possible they may receive pharmacotherapy or other clinical intervention from her mental health provider. It will be up to the clinician providing care to determine the need to clarify the pregnancy status.

* If a patient or healthy control becomes pregnant at anytime throughout the study, the patient will be withdrawn from the study.

Eligibility last updated 6/7/22.  Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Frye, M.D.

Open for enrollment

Contact information:

Danielle Cox

(507) 255-5527

Cox.Danielle@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20509119

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