Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

NCT03179696 | Completed DMC

• 2 other identifiers: R61MH1100191R61MH110019-01
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; CBSST; mobile CBT; negative symptoms

Outcome Measures

Primary Outcomes (1)

• Defeatist performance beliefs (target mechanism)

  Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.

  Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.

Secondary Outcomes (2)

• 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.

Study Arms (1)

Mobile-assisted CBT

EXPERIMENTAL

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

Interventions

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.

Mobile-assisted CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eric Granholm: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (6)

• 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.

  PMID: 17099070 BACKGROUND

• 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.

  PMID: 15968839 BACKGROUND

• 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.

  PMID: 22080492 BACKGROUND

• 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.

  PMID: 24911420 BACKGROUND

• 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.

  PMID: 26475673 BACKGROUND

• 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.

  PMID: 33258792 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric L. Granholm, PhD

  University of California, San Diego; San Diego Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor In Residence

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 7, 2017
• Study Start: August 15, 2016
• Primary Completion: July 19, 2018
• Study Completion: October 31, 2018
• Last Updated: November 8, 2024

Record last verified: 2024-11