NCT02967835

Brief Summary

Will Tele-psychiatry be effective and acceptable to patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

September 12, 2016

Last Update Submit

February 5, 2019

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Depression Outcome

    Will measure depression outcome by measuring PHQ9 score at baseline and 6 months after initial tele-psychiatry consult.

    6 month

  • Anxiety Outcome

    Will measure Anxiety outcome by using GAD7 score at baseline and 6 months after initial tele-psychiatry consult.

    6 month

Secondary Outcomes (1)

  • Patient satisfaction with tele-psychiatry consult

    baseline visit

Study Arms (1)

Telepsychiatry Consult

EXPERIMENTAL

One time tele-psychiatry consultation to provide treatment recommendations for patients primary care physician.

Behavioral: Tele-psychiatry consult

Interventions

Tele-psychiatry consultBEHAVIORAL

tele-psychiatry consult for evaluation and treatment recommendations

Telepsychiatry Consult

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in complex care management
  • PHQ9 above 10 or GAD7 above 10.

You may not qualify if:

  • Not able to provide informed consent
  • Severe cognitive impairments or sensory deficits
  • Not able to understand and speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Mohit Chauhan

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

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
Senior Associate Consultant

Study Record Dates

First Submitted

September 12, 2016

First Posted

November 18, 2016

Study Start

February 1, 2017

Primary Completion

June 14, 2017

Study Completion

June 14, 2017

Last Updated

February 7, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)