Mobile CBT for Negative Symptoms (mCBTn)
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ClinicalTrials.gov Identifier: NCT03621774 |
Recruitment Status :
Recruiting
First Posted : August 8, 2018
Last Update Posted : December 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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Schizophrenia Schizoaffective Disorder | Behavioral: Mobile-assisted CBT-informed Skills Training Behavioral: Supportive Contact | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms in Schizophrenia: An RCT |
Actual Study Start Date : | January 18, 2019 |
Estimated Primary Completion Date : | August 31, 2022 |
Estimated Study Completion Date : | August 31, 2022 |

Arm | Intervention/treatment |
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Experimental: Mobile-assisted CBT-informed Skills Training
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).
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Behavioral: Mobile-assisted CBT-informed Skills Training
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. |
Placebo Comparator: Supportive Contact
An active group leader- and device-contact control group.
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Behavioral: Supportive Contact
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. |
- Defeatist performance beliefs (target mechanism) using the Defeatist Performance Attitude Scale [ Time Frame: Assess change from baseline in defeatist performance beliefs at weeks 9, 18, and 42. ]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.
- Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Assess change from baseline in negative symptoms at weeks 9, 18, and 42. ]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.
- Pupillary responses as effort biomarker [ Time Frame: Assess change from baseline in pupil dilation at weeks 9, 18, and 42. ]Measure changes in pupil dilation recorded during a digit span task.
- Birchwood Social Functioning Scale (SFS) [ Time Frame: Assess change from baseline in functioning at weeks 9, 18, and 42. ]Measure changes in functioning on the SFS. The SFS is a self-report assessment of functioning with 7 subscales, and each item is rated from 0 to 3 with the exception of the Occupation/Employment subscale if a participant is in regular employment (scores range from 7-10 based upon type of work). The subscales and score ranges are: Social Engagement Withdrawal (0-15), Interpersonal Communication/Relationships (0-30), Prosocial Activities (0-66), Recreation (0-48), Independence-Performance (0-39), Independence-Competence (0-39), and Occupation/Employment (0-10). Higher scores indicate better functioning for all subscales.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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 skills training (e.g., hospitalized; severe medical illness).
- Unable to adequately see or manually manipulate the mobile device.

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): NCT03621774
Contact: Eric L. Granholm, Ph.D. | 858-552-8585 ext 7563 | egranholm@ucsd.edu | |
Contact: Jason Holden, Ph.D. | 858-246-2517 | jlholden@ucsd.edu |
United States, California | |
UC San Diego | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Jason Holden 858-246-2517 jlholden@health.ucsd.edu |
Principal Investigator: | Eric Granholm, Ph.D. | UC San Diego |
Responsible Party: | Eric Granholm, Professor In Residence, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03621774 |
Other Study ID Numbers: |
R33MH110019 ( U.S. NIH Grant/Contract ) |
First Posted: | August 8, 2018 Key Record Dates |
Last Update Posted: | December 7, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Schizophrenia CBT Mobile CBT Negative Symptoms |
Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |