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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Behavioral: Mobile-assisted CBT-informed Skills Training Behavioral: Supportive Contact||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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).
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.
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.
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 email@example.com|
|Contact: Jason Holden, Ph.D.||firstname.lastname@example.org|
|United States, California|
|UC San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Jason Holden 858-246-2517 email@example.com|
|Principal Investigator:||Eric Granholm, Ph.D.||UC San Diego|