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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03062267
Other study ID # STUDY00001274
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date May 31, 2020

Study information

Verified date October 2020
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Testing an mHealth mobile interventionist texting program on illness management.


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).


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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).

Study Design


Intervention

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

Locations

Country Name City State
United States Thresholds Chicago Illinois
United States Frontier Behavioral Health Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction With Treatment 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. 3 months
Primary 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
Primary 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 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. Change from baseline to 3 months and 6 months
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