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Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training
This study is evaluating whether motivational enhancement can improve outcomes of cognitive rehabilitation in Veterans with schizophrenia spectrum disorders. Approximately 120 individuals will be randomized to either a 2-session motivational interview (MI, experimental condition) or a 2-session assessment and feedback on learning styles (CI, active control), and will then be asked to participate in 4 months of cognitive rehabilitation. Booster MI or CI sessions will be administered monthly over the course of the cognitive rehabilitation. Primary outcome is number of cognitive rehabilitation sessions attended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI condition | Experimental | motivational interview condition |
|
| CI condition | Sham Comparator | learning style interview condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motivational interviewing | Behavioral | motivational interviewing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sessions Attended | number of cognitive training sessions attended | end of four month training period |
| Number of Sessions Attended | number of sessions attended among patients who attended at least 1 session | end of 4 month training period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna M. Fiszdon, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States |
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Data will be available once primary and secondary study aims have been published.
Completely de-identified data will be made available to other investigators, with written request and IRB approval, ideally under a data use agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | MI Condition | motivational interview condition motivational interviewing: motivational interviewing |
| FG001 | CI Condition | learning style interview condition learning style interviews: interview and feedback about learning style |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MI Condition | motivational interview condition motivational interviewing: motivational interviewing |
| BG001 | CI Condition | learning style interview condition learning style interviews: interview and feedback about learning style |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Sessions Attended | number of cognitive training sessions attended | Posted | Mean | Standard Deviation | sessions | end of four month training period |
|
|
baseline to end of study participation, approximately 5 months later
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MI Condition | motivational interview condition motivational interviewing: motivational interviewing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| admit/chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER/fall | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanna Fiszdon, PhD | VA Connecticut Healthcare System | 2039325711 | 2231 | joanna.fiszdon@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2021 | Sep 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| learning style interviews |
| Behavioral |
interview and feedback about learning style |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Marital status | Count of Participants | Participants |
|
| Number of hospitalizations | Median | Inter-Quartile Range | hospitalizations |
|
| Participants |
|
|
|
| Primary | Number of Sessions Attended | number of sessions attended among patients who attended at least 1 session | participants who attended at least 1 cognitive training session | Posted | Mean | Standard Deviation | sessions | end of 4 month training period |
|
|
|
|
| 0 |
| 56 |
| 4 |
| 56 |
| 1 |
| 56 |
| EG001 | CI Condition | learning style interview condition learning style interviews: interview and feedback about learning style | 0 | 58 | 4 | 58 | 1 | 58 |
| admit/suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| admit/dental | General disorders | Non-systematic Assessment |
|
| admit/abnrml blood | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| admit/sub abuse | Psychiatric disorders | Non-systematic Assessment |
|
| admit/cellulitis | General disorders | Non-systematic Assessment |
|
| admit/lower extr pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| admit/hallucinations | Psychiatric disorders | Non-systematic Assessment |
|
| ER/suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |