Trial · NCT04273685
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline) | Post study at 12 weeks and follow up 3-5 months post study | The Social and Occupational Functional Assessment Scale is a global rating of current functioning ranging from 0 to 100.Lower scores represent lower functioning and higher scores represent higher functioning.For example a score of 100 represents superior functioning in a wide range of activities,a score of 50 represents serious impairment in social, occupational or school functioning, a score of 30 represents an inability to function in almost all areas of activity. The minimum value is 0 and the maximum value is 100. |
| Secondary | Time Use Survey | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Time Use Survey is a semi-structured interview that enquires about time spent over the past month on work, education, voluntary work, leisure, sports, housework or chores, and child care. Time spent on each of the activities is calculated in terms of the average number of hours per week. The activities are summed to create two scores: constructive economic activity (work, education, voluntary work, housework or chores, and child care) and structured activity (constructive economic activity plus leisure and sports activities).A higher score indicates superior social functioning, a lower score represents impaired social functioning. Less than 45 hours of structured activity per week is considered a threshold for being at risk of social disability, less than 30 hours per week is threshold for social disability and indicative of poor social functioning, and less than 15 hours per week is considered to reflect serious social disability. |
| Secondary | Cambridge Neuropsychological Test Automated Battery (CANTAB)- Emotion Recognition Task- change being assessed. | Baseline, post study at 12 weeks and 3-5 months post study | This task measures the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude. Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise). The task takes 6 minutes to complete. |
| Secondary | The Reading the mind in the eyes task- change being assessed. | Baseline, post study at 12 weeks,follow up 3-5 months post study | This task measures the capacity to understand mental states of others from expressions in the eye region of the face. Participants view 36 photos and choose the most accurate descriptor word from four choices for the thought/feeling that was portrayed. As noted above, definitions of the response choices are embedded in the task. The dependent measure was the total number of correct responses, ranging from 0 to 36 |
| Secondary | The Hinting Task - change being assessed. | Baseline, post study at 12 weeks,follow up 3-5 months post study | This task examines the ability to infer the true intent of indirect speech. Ten short passages presenting an interaction between two characters are read aloud. Each passage ends with one of the characters dropping a hint, and participants explain what the character truly meant. If the first response provided was inaccurate, a second hint is delivered, allowing participants to earn partial credit. Total scores range from 0 to 20 |
| Secondary | The Bell Lysaker Emotion Recognition Task (BLERT)- change being assessed. | Baseline, post study at 12 weeks,follow up 3-5 months post study | This task measures recognition of seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion. Participants identified the emotion shown in 21 videos of a male actor providing dynamic facial, vocal-tonal, and upper-body movement cues. Performance Is indexed as the total number of correctly identified emotions (ranging from 0 to 21). |
| Secondary | Wechsler abbreviated scale of intelligence- similarities and matrix reasoning subtests | Baseline, post study at 12 weeks,follow up 3-5 months post study | The similarities and matrix reasoning subtests from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III) is a brief, reliable measure of cognitive ability for use in clinical, educational and research settings. The similarities subtests scores range from 0 - 33 with higher scores indicating better verbal comprehension. Matrix reasoning subtest scores range from 0 - 26 with higher scores reflecting better perceptual organization. Once raw scores are derived they are converted to scaled scores adjusted for age. |
| Secondary | Wechsler Memory scale 3rd edition- logical memory and letter number sequencing subtests | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Wechsler Memory Scale 3rd edition, logical memory subtest is used to assess episodic and auditory memory in immediate and delayed conditions.Logical memory immediate scores range from 0-75, and delayed scores range from 0-50. The letter-number sequencing subtest from the Wechsler Memory Scale 3rd edition is used to assess working memory. Scores range from 0-21. Higher scores on the Wechsler Memory Scale 3rd edition subtests indicate better memory function. Raw scores are converted to scaled scores adjusted for age. |
| Secondary | Rey Osterreith Complex Figure (ROCF) | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Rey Osterreith Complex Figure is an assessment which measures visual memory by asking the participant to reproduce a complicated line drawing, first by copying it freehand and then drawing from memory (immediate and delayed conditions). Scores range from 0-36 with higher scores indicating better visual memory. |
| Secondary | STROOP | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Stroop test measures a person's sustained attention for word reading and color naming with/without interference. A computerized Stroop task measures mean reaction times (RTs) for congruent and incongruent trials. Four colour words (green, red, yellow, and blue) written in congruent or incongruent colour are randomly presented on screen. The Stroop test detects attentional interference via the measurement of response latency (calculated as mean RT for incongruent trials minus mean RT for congruent trials) when participants are asked to inhibit word meaning and indicate the ink colour of the word. Longer latencies are interpreted as greater interference by word content and lower executive function. |
| Secondary | The Positive and Negative Symptom Scale (PANSS) | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Positive and Negative Syndrome Scale (PANSS) is a 30 item scale used to assess symptom severity which includes positive, negative, and general symptom subscales and total scores. Scores range from 7 to 49 for positive and negative symptoms, 16 to 112 for general symptoms, and 30 to 210 for total score. Higher scores indicate higher symptom severity. |
| Other | The Intrinsic Motivation Inventory (IMI) | post study at 12 weeks,follow up 3-5 months post study | The Intrinsic Motivation Inventory is a multidimensional self-report measure of intrinsic motivation intended to assess participant's subjective experience related to a target activity. The instrument can be modified to fit different activities (i.e. therapy). The instrument assesses participant's interest/enjoyment, effort, pressure/ tension, perceived choice and value/usefulness, thus yielding five subscale scores. In the subscales each item is a statement and the participant must indicate the extent to which they agree or disagree with the statement. Item scores range from 1-7 with 1 indicating disagreement and 7 indicating agreement. Subscale scores are calculated by averaging the items scores for the number of items on each subscale. Higher scores indicate more of the concept described in the subscale name. |
| Other | The Need for Cognition Scale (NCS) | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Need for Cognition Scale is an 18-item scale that assesses the degree to which participants seek out cognitively challenging activities of daily living and will provide supplementary information to the social and occupational functioning outcome measures. Each item of the scale contains statements relating to cognitive activities and participants must indicate whether or not the statement is characteristic of them or what they do. Item scores range from 1-5 with 1 indicating a statement is extremely uncharacteristic and 5 indicating a statement is extremely characteristic. Item scores are summed with a lowest possible score of -72 and highest score of 72. Higher scores indicate greater tendency to seek out cognitively challenging activities. |
| Other | Computerised Theory of Mind Task (c-TOM) | Baseline, post study at 12 weeks,follow up 3-5 months post study | The Computerised Theory of Mind Task is a novel task measuring theory of mind, it is divided into two separate tests: 1. C-TOM Gaze - this test examines eye gaze discrimination using videos of actors making eye movements. 2. C-TOM stories- this test presents short videos of simple stories featuring two characters. This task takes approx. 8 minutes to complete. Scores are measured in terms of number of correct responses (ranging from 0 to 80) with higher scores indicating superior theory of mind ability. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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