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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile-assisted CBT
Sponsored by
Eric Granholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, CBSST, mobile CBT, negative symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mobile-assisted CBT

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Defeatist performance beliefs (target mechanism)
    Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.

    Secondary Outcome Measures

    Pupillary responses as effort biomarker
    Measure changes in pupil dilation recorded during a digit span task.
    Clinical Assessment Interview for Negative Symptoms (CAINS)
    Measure changes in motivational negative symptoms on the CAINS.

    Full Information

    First Posted
    May 25, 2017
    Last Updated
    September 1, 2020
    Sponsor
    Eric Granholm
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03179696
    Brief Title
    Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
    Acronym
    mCBTn
    Official Title
    Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 15, 2016 (Actual)
    Primary Completion Date
    July 19, 2018 (Actual)
    Study Completion Date
    October 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eric Granholm
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizoaffective Disorder
    Keywords
    Schizophrenia, CBSST, mobile CBT, negative symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile-assisted CBT
    Arm Type
    Experimental
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Mobile-assisted CBT
    Intervention Description
    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 Measure Information:
    Title
    Defeatist performance beliefs (target mechanism)
    Description
    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 Outcome Measure Information:
    Title
    Pupillary responses as effort biomarker
    Description
    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.
    Title
    Clinical Assessment Interview for Negative Symptoms (CAINS)
    Description
    Measure changes in motivational negative symptoms on the CAINS.
    Time Frame
    Assess change from baseline in negative symptoms at week 12, 18 and 24.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric L. Granholm, PhD
    Organizational Affiliation
    University of California, San Diego; San Diego Veterans Healthcare System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17099070
    Citation
    Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
    Results Reference
    background
    PubMed Identifier
    15968839
    Citation
    Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. doi: 10.1177/070674370505000503.
    Results Reference
    background
    PubMed Identifier
    22080492
    Citation
    Granholm E, Ben-Zeev D, Link PC, Bradshaw KR, Holden JL. Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. Schizophr Bull. 2012 May;38(3):414-25. doi: 10.1093/schbul/sbr155. Epub 2011 Nov 10.
    Results Reference
    background
    PubMed Identifier
    24911420
    Citation
    Granholm E, Holden J, Link PC, McQuaid JR. Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: improvement in functioning and experiential negative symptoms. J Consult Clin Psychol. 2014 Dec;82(6):1173-85. doi: 10.1037/a0037098. Epub 2014 Jun 9.
    Results Reference
    background
    PubMed Identifier
    26475673
    Citation
    Granholm E, Ruiz I, Gallegos-Rodriguez Y, Holden J, Link PC. Pupillary Responses as a Biomarker of Diminished Effort Associated With Defeatist Attitudes and Negative Symptoms in Schizophrenia. Biol Psychiatry. 2016 Oct 15;80(8):581-8. doi: 10.1016/j.biopsych.2015.08.037. Epub 2015 Sep 15.
    Results Reference
    background
    PubMed Identifier
    33258792
    Citation
    Granholm E, Holden J, Dwyer K, Mikhael T, Link P, Depp C. Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. JMIR Ment Health. 2020 Dec 1;7(12):e24406. doi: 10.2196/24406.
    Results Reference
    derived

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    Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

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