Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
mhealth, texting intervention, mobile health, mobile mental health
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).
Interventions
OTHERMobile Interventionist
A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Treatment | 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. |
Countries
United States
Participant flow
Pre-assignment details
No significant events to report that occurred after participant enrollment but prior to assignment of participants to an arm.
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual Treatment as usual for 3 months. | 12 |
| Mobile Interventionist Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.
Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones) | 37 |
| Total | 49 |
Baseline characteristics
| Characteristic | Treatment as Usual | Total | Mobile Interventionist |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12 | 44.8 years STANDARD_DEVIATION 11.2 | 45.4 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 42 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 12 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 24 Participants | 17 Participants |
| Region of Enrollment United States | 12 participants | 49 participants | 37 participants |
| Sex/Gender, Customized Female | 7 Participants | 22 Participants | 15 Participants |
| Sex/Gender, Customized Male | 5 Participants | 27 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 37 |
| other Total, other adverse events | 0 / 12 | 0 / 37 |
| serious Total, serious adverse events | 0 / 12 | 0 / 37 |
Outcome results
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.
Time frame: Change from baseline to 3 months and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Psychiatric Symptoms | Score at 3 months | 6.2 score on a scale | Standard Deviation 14.4 |
| Treatment as Usual | Psychiatric Symptoms | Score at 6 months | .6 score on a scale | Standard Deviation 1.9 |
| Treatment as Usual | Psychiatric Symptoms | Score at Baseline | 5.2 score on a scale | Standard Deviation 11.2 |
| Mobile Interventionist | Psychiatric Symptoms | Score at Baseline | 19.6 score on a scale | Standard Deviation 20.4 |
| Mobile Interventionist | Psychiatric Symptoms | Score at 3 months | 15.1 score on a scale | Standard Deviation 16.7 |
| Mobile Interventionist | Psychiatric Symptoms | Score at 6 months | 17.9 score on a scale | Standard Deviation 19.1 |
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.
Time frame: Change from baseline to 3 months and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Psychiatric Symptoms | Score at Baseline | 18.5 score on a scale | Standard Deviation 13.7 |
| Treatment as Usual | Psychiatric Symptoms | Score at 3 Months | 17.2 score on a scale | Standard Deviation 11.3 |
| Treatment as Usual | Psychiatric Symptoms | Score at 6 Months | 15.5 score on a scale | Standard Deviation 11.2 |
| Mobile Interventionist | Psychiatric Symptoms | Score at Baseline | 18.5 score on a scale | Standard Deviation 11.4 |
| Mobile Interventionist | Psychiatric Symptoms | Score at 3 Months | 23.4 score on a scale | Standard Deviation 12.4 |
| Mobile Interventionist | Psychiatric Symptoms | Score at 6 Months | 14.8 score on a scale | Standard Deviation 10.3 |
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.
Time frame: Change from baseline to 3 months and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Recovery | Score at Baseline | 91.8 score on a scale | Standard Deviation 14.6 |
| Treatment as Usual | Recovery | Score at 3 Months | 90.0 score on a scale | Standard Deviation 13.8 |
| Treatment as Usual | Recovery | Score at 6 Months | 93.8 score on a scale | Standard Deviation 13.1 |
| Mobile Interventionist | Recovery | Score at Baseline | 89.8 score on a scale | Standard Deviation 17.3 |
| Mobile Interventionist | Recovery | Score at 3 Months | 92.9 score on a scale | Standard Deviation 15.5 |
| Mobile Interventionist | Recovery | Score at 6 Months | 94.4 score on a scale | Standard Deviation 14.9 |
Other Pre-specified
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Satisfaction With Treatment | 28.2 score on a scale | Standard Deviation 6.2 |
| Mobile Interventionist | Satisfaction With Treatment | 30.1 score on a scale | Standard Deviation 6.1 |