Bipolar Disorder, Schizophrenia
Conditions
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.
Interventions
BEHAVIORALCBT2go
CBT administered using mobile intervention.
DEVICESmartphone
A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Brief Psychiatric Rating Scale (BPRS) | Baseline, 6 weeks, 12 weeks, and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPECIFIC LEVEL OF FUNCTION (SLOF) | Baseline, 12 weeks, 24 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dysfunctional Attitudes Scale (DAS) | Baseline, mid-point (6 weeks), at post-treatment (12 weeks), 24 week follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm. | 77 |
| 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.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm. | 69 |
| Standard Care Participants assigned to this condition will only participate in the assessments. | 83 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 16 | 2 |
Baseline characteristics
| Characteristic | CBT2go | EMA-only | Standard Care | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 69 Participants | 83 Participants | 229 Participants |
| Age, Continuous | 51.2 YEARS STANDARD_DEVIATION 11.5 | 49.4 YEARS STANDARD_DEVIATION 11.1 | 48.1 YEARS STANDARD_DEVIATION 11.7 | 49.3 YEARS STANDARD_DEVIATION 11.5 |
| Brief Psychiatric Rating Scale TOTAL | 43.2 units on a scale STANDARD_DEVIATION 9.7 | 41.6 units on a scale STANDARD_DEVIATION 11.5 | 42.0 units on a scale STANDARD_DEVIATION 10.9 | 42.3 units on a scale STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 17 Participants | 14 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 45 Participants | 64 Participants | 168 Participants |
| Region of Enrollment United States | 77 Participants | 69 Participants | 83 Participants | 229 Participants |
| Sex: Female, Male Female | 36 Participants | 28 Participants | 36 Participants | 100 Participants |
| Sex: Female, Male Male | 41 Participants | 41 Participants | 47 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 85 | 0 / 85 |
| other Total, other adverse events | 10 / 85 | 12 / 85 | 9 / 85 |
| serious Total, serious adverse events | 0 / 85 | 0 / 85 | 0 / 85 |
Outcome results
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.
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT2go | Score on the Brief Psychiatric Rating Scale (BPRS) | 12 weeks | 39.7 units on a scale | Standard Deviation 11.9 |
| CBT2go | Score on the Brief Psychiatric Rating Scale (BPRS) | 24 Weeks | 39.7 units on a scale | Standard Deviation 11.9 |
| CBT2go | Score on the Brief Psychiatric Rating Scale (BPRS) | Baseline | 43.2 units on a scale | Standard Deviation 9.7 |
| CBT2go | Score on the Brief Psychiatric Rating Scale (BPRS) | 6 weeks | 41.0 units on a scale | Standard Deviation 11.1 |
| EMA-only | Score on the Brief Psychiatric Rating Scale (BPRS) | 12 weeks | 38.6 units on a scale | Standard Deviation 9.1 |
| EMA-only | Score on the Brief Psychiatric Rating Scale (BPRS) | 6 weeks | 39.6 units on a scale | Standard Deviation 7.7 |
| EMA-only | Score on the Brief Psychiatric Rating Scale (BPRS) | 24 Weeks | 37.6 units on a scale | Standard Deviation 10.1 |
| EMA-only | Score on the Brief Psychiatric Rating Scale (BPRS) | Baseline | 41.6 units on a scale | Standard Deviation 11.5 |
| Standard Care | Score on the Brief Psychiatric Rating Scale (BPRS) | 24 Weeks | 41.1 units on a scale | Standard Deviation 11.4 |
| Standard Care | Score on the Brief Psychiatric Rating Scale (BPRS) | Baseline | 42.0 units on a scale | Standard Deviation 10.9 |
| Standard Care | Score on the Brief Psychiatric Rating Scale (BPRS) | 6 weeks | 41.0 units on a scale | Standard Deviation 11.3 |
| Standard Care | Score on the Brief Psychiatric Rating Scale (BPRS) | 12 weeks | 41.0 units on a scale | Standard Deviation 11.4 |
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.
Time frame: Baseline, 12 weeks, 24 weeks
Population: There was missing data due to lack of available informants for the SLOF so that the number analyzed is less than that associated with the other measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT2go | SPECIFIC LEVEL OF FUNCTION (SLOF) | 12 weeks | 129.1 units on a scale | Standard Deviation 15.8 |
| CBT2go | SPECIFIC LEVEL OF FUNCTION (SLOF) | Baseline | 126.9 units on a scale | Standard Deviation 15.2 |
| CBT2go | SPECIFIC LEVEL OF FUNCTION (SLOF) | 24 Weeks | 130.0 units on a scale | Standard Deviation 16.9 |
| EMA-only | SPECIFIC LEVEL OF FUNCTION (SLOF) | 12 weeks | 127.8 units on a scale | Standard Deviation 16.1 |
| EMA-only | SPECIFIC LEVEL OF FUNCTION (SLOF) | Baseline | 128.4 units on a scale | Standard Deviation 15.51 |
| EMA-only | SPECIFIC LEVEL OF FUNCTION (SLOF) | 24 Weeks | 128.7 units on a scale | Standard Deviation 16.3 |
| Standard Care | SPECIFIC LEVEL OF FUNCTION (SLOF) | Baseline | 126.9 units on a scale | Standard Deviation 16.1 |
| Standard Care | SPECIFIC LEVEL OF FUNCTION (SLOF) | 24 Weeks | 123.3 units on a scale | Standard Deviation 18 |
| Standard Care | SPECIFIC LEVEL OF FUNCTION (SLOF) | 12 weeks | 123.4 units on a scale | Standard Deviation 15.8 |
Other Pre-specified
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.
Time frame: Baseline, mid-point (6 weeks), at post-treatment (12 weeks), 24 week follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT2go | Dysfunctional Attitudes Scale (DAS) | Baseline | 49.9 units on a scale | Standard Deviation 18.8 |
| CBT2go | Dysfunctional Attitudes Scale (DAS) | 6 weels | 47.8 units on a scale | Standard Deviation 19 |
| CBT2go | Dysfunctional Attitudes Scale (DAS) | 12 weeks | 47.0 units on a scale | Standard Deviation 18.3 |
| CBT2go | Dysfunctional Attitudes Scale (DAS) | 24 weeks | 45.2 units on a scale | Standard Deviation 19 |
| EMA-only | Dysfunctional Attitudes Scale (DAS) | 24 weeks | 48.0 units on a scale | Standard Deviation 19 |
| EMA-only | Dysfunctional Attitudes Scale (DAS) | Baseline | 49.9 units on a scale | Standard Deviation 18.2 |
| EMA-only | Dysfunctional Attitudes Scale (DAS) | 12 weeks | 46.0 units on a scale | Standard Deviation 17.4 |
| EMA-only | Dysfunctional Attitudes Scale (DAS) | 6 weels | 49.9 units on a scale | Standard Deviation 18 |
| Standard Care | Dysfunctional Attitudes Scale (DAS) | 24 weeks | 48.6 units on a scale | Standard Deviation 16.4 |
| Standard Care | Dysfunctional Attitudes Scale (DAS) | 6 weels | 49.6 units on a scale | Standard Deviation 15.4 |
| Standard Care | Dysfunctional Attitudes Scale (DAS) | 12 weeks | 51.3 units on a scale | Standard Deviation 18.9 |
| Standard Care | Dysfunctional Attitudes Scale (DAS) | Baseline | 49.3 units on a scale | Standard Deviation 17.8 |