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Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia (mCBTn)

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ClinicalTrials.gov Identifier: NCT03179696
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Granholm, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Mobile-assisted CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : July 19, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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).
Behavioral: Mobile-assisted CBT
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179696


Sponsors and Collaborators
Eric Granholm
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Eric L. Granholm, PhD University of California, San Diego; San Diego Veterans Healthcare System
Publications:
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Responsible Party: Eric Granholm, Professor In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03179696    
Other Study ID Numbers: 1R61MH110019 ( U.S. NIH Grant/Contract )
1R61MH110019-01 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Granholm, University of California, San Diego:
Schizophrenia
CBSST
mobile CBT
negative symptoms
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders