Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Primary Endpoint
- Defeatist performance beliefs (target mechanism)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mobile-assisted CBT
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).
Intervention: Mobile-assisted CBT (Behavioral)
Outcomes
Primary Outcomes
Defeatist performance beliefs (target mechanism)
Time Frame: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.
Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.
Secondary Outcomes
- Pupillary responses as effort biomarker(Assess change from baseline in pupil dilation at week 12, 18 and 24.)
- Clinical Assessment Interview for Negative Symptoms (CAINS)(Assess change from baseline in negative symptoms at week 12, 18 and 24.)
Investigators
Eric Granholm
Professor In Residence
University of California, San Diego