Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

Eric Granholm31 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

Mobile-assisted CBTBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * DSM-5 diagnosis of schizophrenia or schizoaffective disorder. * 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. * Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness). * Unable to adequately see or manually manipulate the mobile device.

Outcomes

Primary Outcomes

Defeatist performance beliefs (target mechanism)

Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.

Time frame: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.

Secondary Outcomes

Pupillary responses as effort biomarker

Measure changes in pupil dilation recorded during a digit span task.

Time frame: 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.

Time frame: Assess change from baseline in negative symptoms at week 12, 18 and 24.

Data from ClinicalTrials.gov

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