Psychosis
Conditions
Keywords
psychosis, social function, social cognition
Brief summary
Psychotic spectrum disorders (PSD) are associated with poor social function. By doing this study, the investigators hope to learn which of two different types of 2-month long training courses is more effective in improving day-to-day interactions and quality of life.
Detailed description
Participants will be randomly assigned to one of the two training courses. All participants will be asked to fill out questionnaires, engage in interviews, and complete paper and pencil tasks at the beginning of the study, at the halfway point of the training course (1 month), and end of the training course (2 months), and another 2 months later. One training focuses on how to make good judgments about what other people may be thinking or feeling in social situations, and why people might act in certain ways in different situations. The other training focuses on different strategies for handling everyday problems and stressors. Both trainings are done in one-on-one sessions with a research staff member. There will be 16-20 training sessions, each about 45-60 minutes long. The investigators will ask participants to attend 2 training sessions per week, so the total training time should be about 2 months.
Interventions
BEHAVIORALUSS
social cognitive training
BEHAVIORALMovingForward
problem solving training
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veteran with diagnosis of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder, psychosis NOS, etc); * psychiatrically stable (30 or more days since last hospitalization/change in psychiatric medication) * fluent in English * able to provide legal written informed consent
Exclusion criteria
* current substance use disorder * developmental disability * severe, uncorrected auditory/visual impairment * diagnosis of medical or neurological illness known to impair brain function including dementia, presence of seizures, history of head trauma with loss of consciousness \> 1hr, or clear cognitive sequelae from other illness or injury * currently enrolled in another treatment study targeting, or expected to impact, functioning.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Functioning Scale (SFS) Change | Post-testing (2 months) and follow-up (4 months) | The SFS is one of the best known measures of social functioning in schizophrenia, and was one of two social function measures nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess real-world outcomes based on its psychometric properties, sensitivity to change, relationship to symptoms, and comprehensiveness. The total score ranges from 55 to 135, with a higher score indicates better social functioning. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social functioning compared to baseline. Mid-testing (1 month) score change was included in the mixed-effects model, but its least square mean was not calculated as it was not a time point of interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Skills Performance Assessment (SSPA) Change | Post-training (2 months) and follow-up (4 months). | SSPA is a role-play measure of social skill ability. It consists of two, 3-minute, structured role plays (tenant meeting a new neighbor; tenant calling landlord to request repair). Each role play is rated between 1 and 5. The total score is calculated by summing up the ratings, and ranges from 2 to 10. A higher score indicates better social skill performance. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social skill performance compared to baseline. |
Countries
United States
Participant flow
Pre-assignment details
After obtaining consent but before randomization, 5 participants withdrew and 5 participants did not meet the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Understanding Social Situations (USS) Social cognitive training
USS: social cognitive training | 53 |
| Moving Forward (MF) Problem solving training
Moving Forward: problem solving training | 50 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Allocation (Baseline) | Withdrawal by Subject | 0 | 1 |
| Follow-up (4 Months) | Lost to Follow-up | 2 | 1 |
| Mid-point (1 Month) | Lost to Follow-up | 1 | 2 |
| Mid-point (1 Month) | Missed testing | 5 | 4 |
| Post-testing (2 Months) | Lost to Follow-up | 2 | 3 |
| Post-testing (2 Months) | Missed testing | 1 | 5 |
Baseline characteristics
| Characteristic | Understanding Social Situations (USS) | Total | Moving Forward (MF) |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 91 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 35 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 63 Participants | 28 Participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 47 Participants | 89 Participants | 42 Participants |
| Social Functioning Scale (SFS) | 105.57 units on a scale | 105.79 units on a scale | 107.32 units on a scale |
| Social Skill Performance Assessment (SSPA) | 7.42 units on a scale | 7.42 units on a scale | 7.38 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 50 |
| other Total, other adverse events | 0 / 53 | 0 / 50 |
| serious Total, serious adverse events | 5 / 53 | 7 / 50 |
Outcome results
Primary
Social Functioning Scale (SFS) Change
The SFS is one of the best known measures of social functioning in schizophrenia, and was one of two social function measures nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess real-world outcomes based on its psychometric properties, sensitivity to change, relationship to symptoms, and comprehensiveness. The total score ranges from 55 to 135, with a higher score indicates better social functioning. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social functioning compared to baseline. Mid-testing (1 month) score change was included in the mixed-effects model, but its least square mean was not calculated as it was not a time point of interest.
Time frame: Post-testing (2 months) and follow-up (4 months)
Population: An intention-to-treat analysis, including all randomized participants, was performed. A mixed-effects model was used to include all data points from randomization onward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Understanding Social Situations (USS) | Social Functioning Scale (SFS) Change | Post-testing (2 months) | 1.28 score on a scale |
| Understanding Social Situations (USS) | Social Functioning Scale (SFS) Change | Follow-up (4 months) | 1.56 score on a scale |
| Moving Forward (MF) | Social Functioning Scale (SFS) Change | Post-testing (2 months) | 0.19 score on a scale |
| Moving Forward (MF) | Social Functioning Scale (SFS) Change | Follow-up (4 months) | 0.32 score on a scale |
Secondary
Social Skills Performance Assessment (SSPA) Change
SSPA is a role-play measure of social skill ability. It consists of two, 3-minute, structured role plays (tenant meeting a new neighbor; tenant calling landlord to request repair). Each role play is rated between 1 and 5. The total score is calculated by summing up the ratings, and ranges from 2 to 10. A higher score indicates better social skill performance. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social skill performance compared to baseline.
Time frame: Post-training (2 months) and follow-up (4 months).
Population: An intention-to-treat analysis, including all randomized participants, was performed. A mixed-effects model was used to include all data points from randomization onward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Understanding Social Situations (USS) | Social Skills Performance Assessment (SSPA) Change | Post-training (2 months) | 0.01 score on a scale |
| Understanding Social Situations (USS) | Social Skills Performance Assessment (SSPA) Change | Follow-up (4 months) | 0.00 score on a scale |
| Moving Forward (MF) | Social Skills Performance Assessment (SSPA) Change | Post-training (2 months) | -0.11 score on a scale |
| Moving Forward (MF) | Social Skills Performance Assessment (SSPA) Change | Follow-up (4 months) | -0.03 score on a scale |