Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

Schizophrenia Clinical Trial

— mCBTn  

Official title:

Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179696
• Other study ID #: R61MH110019
• Secondary ID: 1R61MH110019-01
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 31, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eric Granholm	National Institute of Mental Health (NIMH)

References & Publications (5)

Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. Epub 2006 Nov 10. Review. — View 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. — View 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. — View 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. — View Citation

Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pupillary responses as effort biomarker	Measure changes in pupil dilation recorded during a digit span task.	Assess change from baseline in pupil dilation at week 12, 18 and 24.
Secondary	Clinical Assessment Interview for Negative Symptoms (CAINS)	Measure changes in motivational negative symptoms on the CAINS.	Assess change from baseline in negative symptoms at week 12, 18 and 24.