Schizoaffective DisorderNCT03062267
Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
A study testing Mobile Interventionist in people with Schizoaffective Disorder and Schizophrenia, run by University of Washington at 2 sites in United States.
Trial summary
Testing an mHealth mobile interventionist texting program on illness management. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia, Bipolar Disorder
- What is being tested?
- Mobile Interventionist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thresholds
Chicago, Illinois, 60290
Frontier Behavioral Health
Spokane, Washington, 99207
About this study
Testing an mHealth mobile interventionist texting program on illness management.
Read the 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).
- Being tested
- Mobile Interventionist
- Keywords
- mhealth, texting intervention, mobile health, mobile mental health
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile InterventionistOther
A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobile Interventionist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 3 months and 6 months
Secondary outcomes (1)
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.
Measured: Change from baseline to 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Oct 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Ben-Zeev, University of Washington
- Investigators
- Dror Ben-Zeev, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062267
- Sponsor's protocol ID
- STUDY00001274
- Status last verified
- Oct 2020
- First submitted
- 9 Feb 2017
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT03062267
- Acronym / sponsor ID
- STUDY00001274
- Keywords
- mhealth, texting intervention, mobile health, mobile mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 9 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Treatment as usual for 3 months. |
| Mobile Interventionist | Experimental | Other: Mobile InterventionistParticipants will exchange text messages with a mobile interventionist throughout the day for 3 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile InterventionistA mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones) | Other | Mobile Interventionist |
Primary outcome
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.
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.
1 secondary outcome
Recovery
Time frame: Change from baseline to 3 months and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Ben-Zeev, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Interventionist in people with Schizoaffective Disorder and Schizophrenia, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric Symptoms (time frame: Change from baseline to 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.