Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness

Schizophrenia Clinical Trial

Official title:

Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035202
• Other study ID #: R01MH100417
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: May 2017

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Bipolar disorder (BD) and Schizophrenia (SZ) are leading causes of disability and are the costliest disorders to treat among serious mental illnesses. Ample evidence exists that evidence-based psychotherapies such as cognitive behavioral therapy (CBT) produce clinically significant improvements in symptoms of BD and SZ, and yet only 5% of patients in the community can access these treatments. Access to CBT for serious mental illnesses is limited by the restricted pool of trained providers, the resource intensity of these treatments, and cessation of reimbursement for psychological services in many public mental health systems. Our research in BD and SZ over the past five years indicates that mobile phones can provide automated yet personalized cognitive behavioral intervention that is feasible, acceptable, and associated with improvements in symptoms, medication adherence and socialization. Our intervention, called CBT2go, integrates ecological momentary assessment with personalized interventions delivered in the moment that symptoms and related experiences occur. We have developed an innovative platform that functions on various screen types, operating system, or data access technologies, and we have begun to incorporate innovative features into CBT2go, including location-based data and personalized predictive modeling, that can potentially lead to transformative mobile interventions. We propose a research study with the overarching aims of evaluating the effectiveness of CBT2go, gathering necessary data to refine its innovative features, and examining its costs, facilitators, and barriers to implementation in a public mental health system. We propose a randomized controlled trial with three arms: 1) CBT2go, 2) an ecological momentary assessment only condition to control for self-monitoring and device contact, and 3) standard care. A total of 255 participants with either BD or SZ will be recruited from a large public mental health system that has minimal access to CBT. Participants will be assessed at baseline, 6 weeks (mid-treatment), 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome of the study will be clinician rated global psychopathology, and secondary outcomes will include medication adherence, social functioning, and mental health service utilization. Recognizing that not all participants will benefit, we propose to examine differential effectiveness in sub-groups. We will also examine mechanisms of change to inform mobile intervention design, focusing on the impact of CBT2go on cognitive insight and dysfunctional attitudes, which are two mediators of change in traditionally delivered CBT. Drawing from experience in implementation research, we will employ a mixed methods approach to assessing the facilitators, barriers, and costs of adoption of CBT2go from perspectives of consumers, technology experts, administrators and front-line clinicians. This study will lay the groundwork for CBT2go to be adapted and implemented with high fidelity in healthcare settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female age 18-55

2. MINI Diagnosis of either BD I, SZ, or schizoaffective disorder

3. Currently outpatient, participating in routine psychiatric care and prescribed medications for prior past six months

4. No psychotropic medication changes in the past 3 months

5. Capable of providing signed informed consent

Exclusion Criteria:

1. Diagnosis of dementia, seizure disorder, mental retardation, or past head trauma with loss of consciousness for greater than 20 minutes

2. Cannot complete the assessment battery

3. Visual acuity (Snellen chart), reading ability, and manual dexterity sufficient to navigate a touch screen device

4. Symptoms are in "remission" (i.e, scores on all key BPRS items < 3)

5. Currently participating in any other psychosocial interventions

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Disorders
• Schizophrenia

Intervention

Behavioral:
• CBT2go
CBT administered using mobile intervention.

Device:
• Smartphone
A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.

Locations

Country	Name	City	State
United States	UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dysfunctional Attitudes Scale (DAS)	The DAS is a 40-item self-report subscale indexing maladaptive attitudes, particularly one's ability to perform tasks and one's need for approval from others. The DAS consists of 40 items and each item consists of a statement and each is rated on a 7-point Likert scale (7 = fully agree; 1 = fully disagree). Ten items are reverse coded (items: 2, 6, 12, 17, 24, 29, 30, 35, 37 and 40). The total score is the sum of the 40-items and the range of scores is 40-280, with higher scores indicating more dysfunctional attitudes.	Baseline, mid-point (6 weeks), at post-treatment (12 weeks), 24 week follow up
Primary	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	SPECIFIC LEVEL OF FUNCTION (SLOF)	The SLOF is an interviewer rated measure that addresses community function in serious mental illness, utilizing a best estimate approach in which data is integrated from interviewer, informant, and participant responses. The score ranges from 30 to 150. Higher scores equal greater function.	Baseline, 12 weeks, 24 weeks