Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03062267
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Dror Ben-Zeev, University of Washington

Brief Summary:
Testing an mHealth mobile interventionist texting program on illness management.

Condition or disease Intervention/treatment Phase
Schizo Affective Disorder Schizophrenia Bipolar Disorder Major Depressive Disorder Other: Mobile interventionist Not Applicable

Detailed Description:
The ultimate objective is to evaluate a validated mHealth intervention that can be realistically integrated into community mental health settings to increase the availability, reach, and broad impact of illness management approaches for people with serious mental illness (SMI).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Treatment as Usual
Treatment as usual for 3 months.
Experimental: Mobile Interventionist
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.
Other: Mobile interventionist
A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)

Primary Outcome Measures :
  1. Psychiatric Symptoms [ Time Frame: Change from baseline to 3 months and 6 months ]
    Positive and Negative Syndrome Scale (PANSS)

  2. Psychiatric Symptoms [ Time Frame: Change from baseline to 3 months and 6 months ]
    Beck Depression Inventory

Secondary Outcome Measures :
  1. Recovery [ Time Frame: Change from baseline to 3 months and 6 months ]
    Recovery Assessment Scale

  2. Number of hospitalizations per participant [ Time Frame: Change from baseline to 3 months and 6 months ]
    Assessed through electronic medical records and self report

Other Outcome Measures:
  1. Satisfaction with treatment [ Time Frame: 3 months ]
    Satisfaction items established from previous SMI research

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;
  2. 18 years or older;
  3. A rating of "3" or lower on one of three Patient Activation items;
  4. Ownership of a mobile phone with call/text plan;
  5. Receiving community based treatment services.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03062267

Contact: Rachel M Brian, MPH 603-646-7021

United States, Illinois
Thresholds Recruiting
Chicago, Illinois, United States, 60290
Contact: Lisa Razzano, PhD         
Sponsors and Collaborators
University of Washington
Principal Investigator: Dror Ben-Zeev, PhD University of Washington

Responsible Party: Dror Ben-Zeev, Professor, School of Medicine: Psychiatry and Behavioral Sciences, University of Washington Identifier: NCT03062267     History of Changes
Other Study ID Numbers: STUDY00001274
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dror Ben-Zeev, University of Washington:
texting intervention
mobile health
mobile mental health

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Mental Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Pathologic Processes
Behavioral Symptoms