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

Primary Purpose

Schizoaffective Disorder, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Interventionist
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizoaffective Disorder focused on measuring mhealth, texting intervention, mobile health, mobile mental health

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 higher on one of three Patient Activation items;
  4. 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);
  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).

Sites / Locations

  • Thresholds
  • Frontier Behavioral Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual

Mobile Interventionist

Arm Description

Treatment as usual for 3 months.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Recovery
Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery.

Full Information

First Posted
February 9, 2017
Last Updated
October 15, 2020
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03062267
Brief Title
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Official Title
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizoaffective Disorder, Schizophrenia, Bipolar Disorder, Major Depressive Disorder
Keywords
mhealth, texting intervention, mobile health, mobile mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as usual for 3 months.
Arm Title
Mobile Interventionist
Arm Type
Experimental
Arm Description
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.
Intervention Type
Other
Intervention Name(s)
Mobile Interventionist
Intervention Description
A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Primary Outcome Measure Information:
Title
Psychiatric Symptoms
Description
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.
Time Frame
Change from baseline to 3 months and 6 months
Title
Psychiatric Symptoms
Description
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.
Time Frame
Change from baseline to 3 months and 6 months
Secondary Outcome Measure Information:
Title
Recovery
Description
Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery.
Time Frame
Change from baseline to 3 months and 6 months
Other Pre-specified Outcome Measures:
Title
Satisfaction With Treatment
Description
Assessed with satisfaction items established from previous SMI research. This measure consists of 5 items, each rated from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 5-35. Higher scores indicate more satisfaction with treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder; 18 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Ben-Zeev, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thresholds
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60290
Country
United States
Facility Name
Frontier Behavioral Health
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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