Summary

for people ages 18-65 (full criteria)
study started
estimated completion:
Eric L. Granholm

Description

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.

Details

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.

Keywords

Schizophrenia Schizoaffective Disorder CBSST mobile CBT negative symptoms Psychotic Disorders Mobile-assisted CBT

Eligibility

You can join if…

Open to people ages 18-65

  • 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/

You CAN'T join if...

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.

Lead Scientist

  • Eric L. Granholm
    Dr. Granholm is Professor of Psychiatry at UCSD and Associate Chief of Psychology and Director of the Center Of Recovery Education (CORE) treatment program at the VA San Diego Healthcare System. He received his Ph.D. in Clinical Psychology from the University of California, Los Angeles in 1991, and completed a postdoctoral fellowship at the UCLA Semel Institute for Neuroscience and Human Behavior.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eric Granholm
ID
NCT03179696
Study Type
Interventional
Last Updated