N/A
N=255
Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness
Schizophrenia · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02035202 ↗Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Score on the Brief Psychiatric Rating Scale (BPRS) — 43.2; 41.6; 42.0; 41.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT2go (Behavioral); Smartphone (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on the Brief Psychiatric Rating Scale (BPRS) |
43.2; 41.6; 42.0; 41.0; 39.6; 41.0 | — |
| SECONDARY SPECIFIC LEVEL OF FUNCTION (SLOF) |
126.9; 128.4; 126.9; 129.1; 127.8; 123.4 | — |
Summary
The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive behavioral intervention for serious mental illness (SMI) and to identify the facilitators, barriers, and costs of implementation. We would like to determine whether the addition of a mobile phone monitoring software program to a brief behavioral intervention for bipolar disorder or schizophrenia improves symptoms arising from the disorders. In this study we will be assessing the feasibility, acceptability and short term effect of the mobile phone enhanced intervention for bipolar disorder and schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Male or female age 18-55
- MINI Diagnosis of either BD I, SZ, or schizoaffective disorder
- Currently outpatient, participating in routine psychiatric care and prescribed medications for prior past six months
- No psychotropic medication changes in the past 3 months
- Capable of providing signed informed consent
Exclusion Criteria
- Diagnosis of dementia, seizure disorder, mental retardation, or past head trauma with loss of consciousness for greater than 20 minutes
- Cannot complete the assessment battery
- Visual acuity (Snellen chart), reading ability, and manual dexterity sufficient to navigate a touch screen device
- Symptoms are in "remission" (i.e, scores on all key BPRS items < 3)
- Currently participating in any other psychosocial interventions
Data sourced from ClinicalTrials.gov (NCT02035202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.