Psychosis
Conditions
Keywords
psychosis, adherence, motivation
Brief summary
Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training
Detailed description
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.
Interventions
BEHAVIORALmotivational interviewing
motivational interviewing
BEHAVIORALlearning style interviews
interview and feedback about learning style
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of psychotic disorder * 18 years old or older
Exclusion criteria
* meeting criteria for substance abuse/dependence in past 30 days * psychiatric hospitalization in past 30 days * change in psychiatric medications in past 30 days * severe auditory/visual impairment * evidence of developmental disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sessions Attended | end of four month training period | number of cognitive training sessions attended |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MI Condition motivational interview condition
motivational interviewing: motivational interviewing | 56 |
| CI Condition learning style interview condition
learning style interviews: interview and feedback about learning style | 58 |
| Total | 114 |
Baseline characteristics
| Characteristic | MI Condition | CI Condition | Total |
|---|---|---|---|
| Age, Continuous | 56.52 years STANDARD_DEVIATION 10.4 | 53.34 years STANDARD_DEVIATION 12.74 | 55.41 years STANDARD_DEVIATION 11.65 |
| Education | 12.52 years STANDARD_DEVIATION 2.42 | 13.04 years STANDARD_DEVIATION 2.21 | 12.79 years STANDARD_DEVIATION 2.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 53 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital status ever married | 31 Participants | 29 Participants | 60 Participants |
| Marital status never married | 25 Participants | 29 Participants | 54 Participants |
| Number of hospitalizations | 4.0 hospitalizations | 4.0 hospitalizations | 4.0 hospitalizations |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 29 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 43 Participants | 48 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 58 |
| other Total, other adverse events | 1 / 56 | 1 / 58 |
| serious Total, serious adverse events | 4 / 56 | 4 / 58 |
Outcome results
Primary
Number of Sessions Attended
number of cognitive training sessions attended
Time frame: end of four month training period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MI Condition | Number of Sessions Attended | 7.70 sessions | Standard Deviation 10.82 |
| CI Condition | Number of Sessions Attended | 4.98 sessions | Standard Deviation 6.63 |
p-value: 0.24Wilcoxon (Mann-Whitney)
Primary
Number of Sessions Attended
number of sessions attended among patients who attended at least 1 session
Time frame: end of 4 month training period
Population: participants who attended at least 1 cognitive training session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MI Condition | Number of Sessions Attended | 10.51 sessions | Standard Deviation 11.43 |
| CI Condition | Number of Sessions Attended | 7.23 sessions | Standard Deviation 6.91 |
p-value: 0.000195% CI: [1.25, 1.69]Regression, zero-inflated Poisson