Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness
1 other identifier
interventional
255
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Oct 2013
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedAugust 13, 2019
July 1, 2019
3.6 years
October 9, 2013
October 4, 2018
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Score on the Brief Psychiatric Rating Scale (BPRS)
The BPRS-24 includes 24 items that cover depression, anxiety, mania, suicidality, delusions/hallucinations, and unusual behavior. The BPRS is reliable, valid, and sensitive to change in both bipolar disorder and schizophrenia, and therefore enables the examination of diagnosis as a moderator of treatment effect. Twenty four items are rated on a 1-7 scale from present to severe, and the Total Score will be the primary outcome for analyses. It is clinician rated and the minimum score is 24 and the maximum score is 148 and higher scores reflect worse outcome.
Baseline, 6 weeks, 12 weeks, and 24 weeks
Secondary Outcomes (1)
SPECIFIC LEVEL OF FUNCTION (SLOF)
Baseline, 12 weeks, 24 weeks
Other Outcomes (1)
Dysfunctional Attitudes Scale (DAS)
Baseline, mid-point (6 weeks), at post-treatment (12 weeks), 24 week follow up
Study Arms (3)
CBT2go
EXPERIMENTALParticipants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
EMA-only
ACTIVE COMPARATORParticipants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Standard Care
NO INTERVENTIONParticipants assigned to this condition will only participate in the assessments.
Interventions
A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD
San Diego, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colin Depp
- Organization
- UCSD
Study Officials
- PRINCIPAL INVESTIGATOR
Colin Depp, PhD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
October 9, 2013
First Posted
January 14, 2014
Study Start
October 1, 2013
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
August 13, 2019
Results First Posted
August 13, 2019
Record last verified: 2019-07