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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61MH110019-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Clinical Assessment Interview for Negative Symptoms (CAINS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric L. Granholm, PhD | University of California, San Diego; San Diego Veterans Healthcare System | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17099070 | Background | 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. | |
| 15968839 | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Measure changes in motivational negative symptoms on the CAINS.
| Assess change from baseline in negative symptoms at week 12, 18 and 24. |
| 22080492 | 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. |
| 24911420 | 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. |
| 26475673 | 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. |
| 33258792 | Derived | 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. |