NCT05523843

Brief Summary

The proposed study aims to examine the usability, utility, and feasibility of the Tulsa Life Chart (TLC) in a sample of patients seeking mental health treatment and their healthcare providers. The TLC is an interactive, web-based application used to create a graphical interface for visualizing a patient's life history.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

August 22, 2022

Last Update Submit

November 13, 2023

Conditions

Keywords

AssessmentLife ChartWeb-based applicationClinical intake assessmentPragmatic Clinical Pilot

Outcome Measures

Primary Outcomes (2)

  • mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)

    Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability.

    Baseline assessment

  • mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Healthcare Professional)

    Validated self-report survey in which healthcare professional participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability.

    Baseline assessment

Secondary Outcomes (8)

  • mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)

    Baseline assessment

  • mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional)

    Baseline assessment

  • mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient)

    Baseline assessment

  • mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional)

    Baseline assessment

  • mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient)

    Baseline assessment

  • +3 more secondary outcomes

Other Outcomes (16)

  • mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient)

    Assessment two - on average 4 to 12 weeks after baseline assessment

  • Change in perception of usefulness

    Change from baseline to the post-treatment timepoint, approximately 4 - 12 weeks after baseline

  • mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient)

    Assessment two - on average 4 to 12 weeks after baseline assessment

  • +13 more other outcomes

Study Arms (2)

Treatment seeking individuals

Individuals seeking treatment in the Laureate Psychiatric Clinic and Hospital (LPCH).

Other: Tulsa Life Chart (TLC)

Healthcare professionals

Healthcare professionals (HCPS) include nurses, psychologists, therapists, medical doctors, dieticians, etc who work at LPCH and are engaged in direct patient care.

Interventions

The TLC is a self-administered, interactive assessment of patient history. Participants are asked to provide information from birth to their current age in developmental epochs (i.e., ages 0 to 5; 6 to 10; 11 to 14; 15 to 18; 19 to 25; 26 to 35; and so on in 10-year increments). Participants are first asked to rate their average mood during the epoch. They are then asked about locations lived, schools attended, people they were close to, hobbies, medical conditions, medications, hospitalizations, direct and indirect substance use exposure, mental health symptoms, mental health treatment, and important life events. The information is then displayed in an interactive, graphic of the individual's life that is reviewable by the patient and the healthcare providers enrolled in the study that the patient consents to having access.

Treatment seeking individuals

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Indviduals seeking mental health treatment and their healthcare providers who have been invited to participate in the study.

You may qualify if:

  • Actively seeking mental health treatment at Laureate Psychiatric Clinic and Hospital
  • Provision of informed consent or if \<18 assent and parental consent
  • Age 15 to 65 years
  • Necessary resources to engage in a technology-based intervention
  • English proficiency
  • Willingness to grant access to medical records
  • Employed at Laureate Psychiatric Clinic and Hospital in a patient care role
  • Informed consent
  • English proficiency
  • Access to resources to engage in technology-based intervention

You may not qualify if:

  • Active suicidal ideation with plan or intent
  • No access to resources to participate in a technology-based intervention
  • Completed more than 2 sessions of therapy with their current provider prior to enrollment in the study
  • Not proficient in English
  • No access to resources to participate in a technology-based intervention
  • Not proficient in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74008, United States

Location

Related Publications (5)

  • Aupperle RL, Paulus MP, Kuplicki R, Touthang J, Victor T, Yeh HW; Tulsa 1000 Investigators; Khalsa SS. Web-Based Graphic Representation of the Life Course of Mental Health: Cross-Sectional Study Across the Spectrum of Mood, Anxiety, Eating, and Substance Use Disorders. JMIR Ment Health. 2020 Jan 28;7(1):e16919. doi: 10.2196/16919.

    PMID: 32012081BACKGROUND
  • Manderscheid RW, Ryff CD, Freeman EJ, McKnight-Eily LR, Dhingra S, Strine TW. Evolving definitions of mental illness and wellness. Prev Chronic Dis. 2010 Jan;7(1):A19. Epub 2009 Dec 15.

    PMID: 20040234BACKGROUND
  • Post RM, Roy-Byrne PP, Uhde TW. Graphic representation of the life course of illness in patients with affective disorder. Am J Psychiatry. 1988 Jul;145(7):844-8. doi: 10.1176/ajp.145.7.844.

    PMID: 3381929BACKGROUND
  • Born C, Amann BL, Grunze H, Post RM, Scharer L. Saving time and money: a validation of the self ratings on the prospective NIMH Life-Chart Method (NIMH-LCM). BMC Psychiatry. 2014 May 7;14:130. doi: 10.1186/1471-244X-14-130.

    PMID: 24886463BACKGROUND
  • Denicoff KD, Ali SO, Sollinger AB, Smith-Jackson EE, Leverich GS, Post RM. Utility of the daily prospective National Institute of Mental Health Life-Chart Method (NIMH-LCM-p) ratings in clinical trials of bipolar disorder. Depress Anxiety. 2002;15(1):1-9. doi: 10.1002/da.1078.

    PMID: 11816046BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Robin Aupperle, PhD

    Laureate Institute for Brain Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 31, 2022

Study Start

September 12, 2022

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

The current study is enrolling participants from a specific treatment center and the data being collected and visualized as part fo the Tulsa Life Chart would be able to be used to potentially identify the individual participants. Thus, no data from this study will be shared through open access databases. If the visualization data from the TLC is shared for publication, data will be modified to for participant confidentiality and privacy. Data obtained from questionnaire measures may be shared upon request.

Locations