Mobile CBT for Negative Symptoms

NCT03621774 | Completed DMC

• 1 other identifier: R33MH110019
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial will test a combined group contact plus mobile CBT-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; CBT; Mobile CBT; Negative Symptoms

Outcome Measures

Primary Outcomes (2)

• Defeatist performance beliefs (target mechanism) using the Defeatist Performance Attitude Scale

  Measure changes in defeatist performance beliefs severity using the Defeatist Performance Attitude Scale (DPAS). The DPAS is a 5-minute, 15-item self-report subscale derived from factor analysis of the commonly-used 40-item Dysfunctional Attitude Scale, which measures the tendency to overgeneralize from past failure experiences and form defeatist beliefs about the ability to perform future goal-directed tasks. Items are rated on a 1-7 Likert scale. A total score is reported with a range of 7 - 105 with higher total scores indicating more severe defeatist performance attitudes.

  Assess change from baseline in defeatist performance beliefs at weeks 9, 18, and 42.

• Clinical Assessment Interview for Negative Symptoms (CAINS)

  Measure changes in motivational negative symptoms on the CAINS. The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.

  Assess change from baseline in negative symptoms at weeks 9, 18, and 42.

Secondary Outcomes (2)

• Pupillary responses as effort biomarker

  Assess change from baseline in pupil dilation at weeks 9, 18, and 42.

• Birchwood Social Functioning Scale (SFS)

  Assess change from baseline in functioning at weeks 9, 18, and 42.

Study Arms (2)

Mobile-assisted CBT-informed Skills Training

EXPERIMENTAL

Psychosocial intervention combining in-person and smartphone-based CBT-informed skills training for experiential negative symptoms in schizophrenia, called Mobile-assisted Cognitive-Behavioral Therapy for Negative symptoms (mCBTn).

Behavioral: Mobile-assisted CBT-informed Skills Training

Supportive Contact

PLACEBO COMPARATOR

An active group leader- and device-contact control group.

Behavioral: Supportive Contact

Interventions

Mobile-assisted CBT-informed Skills Training BEHAVIORAL

mCBTn combines the CBT-informed components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group skills training and mobile smartphone interventions from our prior clinical trials research.

Mobile-assisted CBT-informed Skills Training

Supportive Contact BEHAVIORAL

The SC intervention will provide the same amount of group and mobile device contact as the mCBTn condition. Participants will be carrying a phone but will not have access to the CBT-informed app. Group contact sessions will be semi-structured and consist of trouble-shooting device use and check-in about symptoms and potential crisis management, followed by a flexible discussion involving psychoeducation, instructions for accessing community crisis lines and related community resources, empathy, and non-directive reinforcement of health, coping, and symptom management behaviors that grow out of group discussions, with only minimal group leader guidance.

Supportive Contact

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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 skills training (e.g., hospitalized; severe medical illness).
• Unable to adequately see or manually manipulate the mobile device.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

Related Publications (5)

• 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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric Granholm, Ph.D.

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor In Residence

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: March 27, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

US (1)