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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USS | Experimental | social cognitive training |
|
| MovingForward | Active Comparator | problem solving training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USS | Behavioral | social cognitive training |
| |
| MovingForward |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-testing (2 months) and follow-up (4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 | 06516-2770 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39238934 | Derived | Fiszdon JM, Bell MD, Fulford D, Roberts DL, Dziura J, Parente L, Nasse A, Choi J. Understanding social situations: study protocol for a randomized controlled trial evaluating a novel social cognitive training versus modified problem-solving training for people with psychosis. Front Psychiatry. 2024 Aug 22;15:1440476. doi: 10.3389/fpsyt.2024.1440476. eCollection 2024. |
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see below
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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After obtaining consent but before randomization, 5 participants withdrew and 5 participants did not meet the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Understanding Social Situations (USS) | social cognitive training USS: social cognitive training |
| FG001 | Moving Forward (MF) | problem solving training MovingForward: problem solving training |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation (Baseline) |
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| ||||||||||||||||||
| Mid-point (1 Month) |
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| Post-testing (2 Months) |
| |||||||||||||||||||
| Follow-up (4 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Understanding Social Situations (USS) | Social cognitive training USS: social cognitive training |
| BG001 | Moving Forward (MF) | Problem solving training Moving Forward: problem solving training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Post-testing (2 months) and follow-up (4 months) |
Up to 4 months.
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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 | Understanding Social Situations (USS) | social cognitive training USS: social cognitive training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure exacerbation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanna Fiszdon, Principal Investigator | VA Connecticut Healthcare System | 203-932-5711 | 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 | Nov 1, 2023 | Jan 28, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2023 | Oct 11, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| Behavioral |
problem solving training |
|
| Post-training (2 months) and follow-up (4 months). |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| 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 |
|
| Social Functioning Scale (SFS) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| Social Skill Performance Assessment (SSPA) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Understanding Social Situations (USS) | social cognitive training USS: social cognitive training |
| OG001 | Moving Forward (MF) | problem solving training MovingForward: problem solving training |
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Post-training (2 months) and follow-up (4 months). |
|
|
|
| 0 |
| 53 |
| 5 |
| 53 |
| 0 |
| 53 |
| EG001 | Moving Forward (MF) | problem solving training MovingForward: problem solving training | 0 | 50 | 7 | 50 | 0 | 50 |
| Toe amputation | Surgical and medical procedures | Non-systematic Assessment |
|
| Delusions/Psychosis | Psychiatric disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Suicide ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Transient ischemic attacks | Nervous system disorders | Non-systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Sprain and strain of ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Substance use | Psychiatric disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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