NCT03062267

Brief Summary

Testing an mHealth mobile interventionist texting program on illness management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

February 9, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 9, 2020

Completed
Last Updated

November 9, 2020

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

February 9, 2017

Results QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Schizoaffective DisorderSchizophreniaBipolar DisorderMajor Depressive Disorder

Keywords

mhealthtexting interventionmobile healthmobile mental health

Outcome Measures

Primary Outcomes (2)

  • Psychiatric Symptoms

    Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.

    Change from baseline to 3 months and 6 months

  • Psychiatric Symptoms

    Assessed with the Beck Depression Inventory (BDI). The Beck Depression Inventory is a psychometric test for measuring the severity of depression. There are 21 items, each rated from 0-3, and total scores range from 0-63. Higher scores indicate more severe depressive symptoms.

    Change from baseline to 3 months and 6 months

Secondary Outcomes (1)

  • Recovery

    Change from baseline to 3 months and 6 months

Other Outcomes (1)

  • Satisfaction With Treatment

    3 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Treatment as usual for 3 months.

Mobile Interventionist

EXPERIMENTAL

Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.

Other: Mobile Interventionist

Interventions

Mobile InterventionistOTHER

A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)

Mobile Interventionist

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;
  • years or older;
  • A rating of "3" or higher on one of three Patient Activation items;
  • Ownership of a mobile phone with call/text plan (research staff will offer assistance in accessing the Federal Lifeline Assistance Program to people who do not have a mobile phone and/or call/text plan if they are otherwise eligible);
  • Receiving community based treatment services.

You may not qualify if:

  • Hearing, vision, or motor impairment that make it impossible to operate a mobile phone (determined using the individual's device for screening);
  • English reading level below 4th grade (determined using the reading section from the Wide Range Achievement Test - 4th Edition (WRAT-4).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thresholds

Chicago, Illinois, 60290, United States

Location

Frontier Behavioral Health

Spokane, Washington, 99207, United States

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Results Point of Contact

Title
Principal Investigator
Organization
University of Washington
dbenzeev@uw.edu
(206) 685-9655

Study Officials

  • Dror Ben-Zeev, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 23, 2017

Study Start

October 1, 2017

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

November 9, 2020

Results First Posted

November 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)