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Completed

NCT Number: NCT03179696

Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile-assisted CBT

Behavioral

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.

Primary outcomes

  1. 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

  1. Pupillary responses as effort biomarker

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

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

  2. Clinical Assessment Interview for Negative Symptoms (CAINS)

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

    Measure changes in motivational negative symptoms on the CAINS.

Sponsors and collaborators

Lead sponsor

Eric Granholm

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: mCBTn

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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