- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03062267
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
October 15, 2020 updated by: Dror Ben-Zeev, University of Washington
Testing an mHealth mobile interventionist texting program on illness management.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60290
- Thresholds
-
-
Washington
-
Spokane, Washington, United States, 99207
- Frontier Behavioral Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e.
basic / smartphones)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychiatric Symptoms
Time Frame: Change from baseline to 3 months and 6 months
|
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
Time Frame: Change from baseline to 3 months and 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery
Time Frame: Change from baseline to 3 months and 6 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction With Treatment
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
May 31, 2020
Study Completion (ACTUAL)
May 31, 2020
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (ACTUAL)
February 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2020
Last Update Submitted That Met QC Criteria
October 15, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001274
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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