Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

Study Overview
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Brief Summary
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This clinical trial will test a combined group therapy plus mobile cognitive behavioral therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order to change motivational negative symptoms linked to defeatist attitudes.

Detailed Description
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The primary purpose of this project is to test whether a psychosocial intervention, Cognitive Behavioral Social Skills Training (CBSST) combined with a smartphone-based cognitive-behavioral therapy for negative symptoms called, Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms (mCBTn) can reduce defeatist performance attitudes in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms.The project will also identify the optimal dose to engage the defeatist attitude target. Pupillary responses, an objective psychophysiological biomarker of effort, will be recorded during a cognitive task as a secondary outcome to determine its potential as an end point in clinical trials of motivation and effort.

Official Title
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Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: Mobile-assisted CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the MINI and record review. Meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three CAINS Motivation and Pleasure domains (mean of 2 -moderate- or greater for items averaged within the Social, Work or Recreational domains) at the beginning and end of a 2-week evaluation phase. Moderate-to-severe defeatist attitudes (DPAS > 50). ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual consumer workbook). Clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0). Exclusion Criteria: Prior CBT in the past 2 years. Greater than moderate PANSS positive symptoms (P1-Delusions, P2- Disorganization, P3-Hallucinations, or P6-Suspiciousness - any item >5). Severe depression on the Calgary Depression Scale for Schizophrenia (CDS >8). Extrapyramidal symptoms (Simpson-Angus Scale >7). Ocular damage, disease, surgery or medications that affect pupil dilation. DSM-5 alcohol or substance use disorder in past 3 months based on the MINI. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness). Unable to adequately see or manually manipulate the mobile device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile-assisted CBT<br>Psychosocial intervention combining in-person and smartphone-based cognitive-behavioral therapy (CBT) for experiential negative symptoms in schizophrenia called, Mobile-assisted Cognitive-Behavioral Therapy for Negative symptoms (mCBTn). | Behavioral: Mobile-assisted CBT<br>* mCBTn combines the CBT components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group therapy and mobile smartphone interventions from our prior clinical trials research.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defeatist performance beliefs (target mechanism) | Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale. | Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillary responses as effort biomarker | Measure changes in pupil dilation recorded during a digit span task. | Assess change from baseline in pupil dilation at week 12, 18 and 24. | 
| Clinical Assessment Interview for Negative Symptoms (CAINS) | Measure changes in motivational negative symptoms on the CAINS. | Assess change from baseline in negative symptoms at week 12, 18 and 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, CBSST, mobile CBT, negative symptoms