Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia (mCBTn)
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|ClinicalTrials.gov Identifier: NCT03179696|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Behavioral: Mobile-assisted CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia|
|Actual Study Start Date :||August 15, 2016|
|Actual Primary Completion Date :||July 19, 2018|
|Estimated Study Completion Date :||October 31, 2018|
Experimental: Mobile-assisted CBT
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
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.
- Defeatist performance beliefs (target mechanism) [ Time Frame: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24. ]Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.
- Pupillary responses as effort biomarker [ Time Frame: Assess change from baseline in pupil dilation at week 12, 18 and 24. ]Measure changes in pupil dilation recorded during a digit span task.
- Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Assess change from baseline in negative symptoms at week 12, 18 and 24. ]Measure changes in motivational negative symptoms on the CAINS.
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): NCT03179696
|Principal Investigator:||Eric L. Granholm, PhD||University of California, San Diego; San Diego Veterans Healthcare System|