Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness

NCT ID: NCT02035202

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-05-31

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.

Detailed 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.

Conditions

Schizophrenia; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT2go

Participants 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.

Group Type: EXPERIMENTAL

CBT2go

Intervention Type: BEHAVIORAL

CBT administered using mobile intervention.

Smartphone

Intervention Type: DEVICE

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

EMA-only

Participants 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.

Group Type: ACTIVE_COMPARATOR

Smartphone

Intervention Type: DEVICE

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

Standard Care

Participants assigned to this condition will only participate in the assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBT2go

CBT administered using mobile intervention.

Intervention Type: BEHAVIORAL

Smartphone

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Colin Depp

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin Depp, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01MH100417

Identifier Type: NIH

Identifier Source: org_study_id

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