Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Trail Making Test (TMT) |
It evaluates selective/alternative visual attention by the time of execution (seconds) |
Baseline |
|
| Primary |
Trail Making Test (TMT) |
It evaluates selective/alternative visual attention by the time of execution (seconds) |
2 months |
|
| Primary |
Trail Making Test (TMT) |
It evaluates selective/alternative visual attention by the time of execution (seconds) |
8 months |
|
| Primary |
Stroop Color-Word Interference Test |
It measures processing speed and visual inhibitory control by the total number of items achieved |
Baseline |
|
| Primary |
Stroop Color-Word Interference Test |
It measures processing speed and visual inhibitory control by the total number of items achieved |
2 months |
|
| Primary |
Stroop Color-Word Interference Test |
It measures processing speed and visual inhibitory control by the total number of items achieved |
8 months |
|
| Primary |
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests |
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements |
Baseline |
|
| Primary |
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests |
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements |
2 months |
|
| Primary |
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests |
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements |
8 months |
|
| Primary |
The Acceptance and Action Questionnaire-II (AAQ-II) |
It evaluates experiential avoidance and psychological inflexibility. It is a 7-item self-report instrument, rated on a 7-point Likert scale, with a total scale score ranging from 7 to 49. Higher scores indicate higher levels of experiential avoidance and psychological inflexibility |
Baseline |
|
| Primary |
The Acceptance and Action Questionnaire-II (AAQ-II) |
It evaluates experiential avoidance and psychological inflexibility. It is a 7-item self-report instrument, rated on a 7-point Likert scale, with a total scale score ranging from 7 to 49. Higher scores indicate higher levels of experiential avoidance and psychological inflexibility |
2 months |
|
| Primary |
The Acceptance and Action Questionnaire-II (AAQ-II) |
It evaluates experiential avoidance and psychological inflexibility. It is a 7-item self-report instrument, rated on a 7-point Likert scale, with a total scale score ranging from 7 to 49. Higher scores indicate higher levels of experiential avoidance and psychological inflexibility |
8 months |
|
| Primary |
The Anxiety Sensitivity Index-3 (ASI-3) |
It measures concerns associated with possible negative consequences of anxiety-related symptoms in three dimensions (physical, cognitive and social). It is an 18-item self-report, rated on a 5-point Likert scale, with a total scale score (ranging from 0 to 72) and three 6-item subscales (Physical, Cognitive and Social Concerns, ranging from 0 to 24 points each). Higher scores indicate higher anxiety sensitivity |
Baseline |
|
| Primary |
The Anxiety Sensitivity Index-3 (ASI-3) |
It measures concerns associated with possible negative consequences of anxiety-related symptoms in three dimensions (physical, cognitive and social). It is an 18-item self-report, rated on a 5-point Likert scale, with a total scale score (ranging from 0 to 72) and three 6-item subscales (Physical, Cognitive and Social Concerns, ranging from 0 to 24 points each). Higher scores indicate higher anxiety sensitivity |
2 months |
|
| Primary |
The Anxiety Sensitivity Index-3 (ASI-3) |
It measures concerns associated with possible negative consequences of anxiety-related symptoms in three dimensions (physical, cognitive and social). It is an 18-item self-report, rated on a 5-point Likert scale, with a total scale score (ranging from 0 to 72) and three 6-item subscales (Physical, Cognitive and Social Concerns, ranging from 0 to 24 points each). Higher scores indicate higher anxiety sensitivity |
8 months |
|
| Secondary |
The Five Facets of Mindfulness Questionnaire (FFMQ) |
It is a self-report instrument of 39 items, rated on a 5-point Likert scale, that are grouped into both a total scale score (with a mean score ranging from 1 to 5) and five specific subscales: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgment (8 items), and Non-reactivity (7 items). Higher values indicate higher levels in each domain |
Baseline |
|
| Secondary |
The Five Facets of Mindfulness Questionnaire (FFMQ) |
It is a self-report instrument of 39 items, rated on a 5-point Likert scale, that are grouped into both a total scale score (with a mean score ranging from 1 to 5) and five specific subscales: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgment (8 items), and Non-reactivity (7 items). Higher values indicate higher levels in each domain |
2 months |
|
| Secondary |
The Five Facets of Mindfulness Questionnaire (FFMQ) |
It is a self-report instrument of 39 items, rated on a 5-point Likert scale, that are grouped into both a total scale score (with a mean score ranging from 1 to 5) and five specific subscales: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgment (8 items), and Non-reactivity (7 items). Higher values indicate higher levels in each domain |
8 months |
|
| Secondary |
The Toronto Alexithymia Scale 20-item (TAS-20) |
It is a self-report instrument that measures both a global factor of alexithymia, and three specific domains: Difficulty in Identifying Feelings (7 items), Difficulty in Describing Feelings (5 items) and Externally Oriented Thinking (8 items). Items are rated on a 5-point Likert scale. The total scale score ranges between 20 and 100, with higher scores indicating greater level of alexithymia |
Baseline |
|
| Secondary |
The Toronto Alexithymia Scale 20-item (TAS-20) |
It is a self-report instrument that measures both a global factor of alexithymia, and three specific domains: Difficulty in Identifying Feelings (7 items), Difficulty in Describing Feelings (5 items) and Externally Oriented Thinking (8 items). Items are rated on a 5-point Likert scale. The total scale score ranges between 20 and 100, with higher scores indicating greater level of alexithymia |
2 months |
|
| Secondary |
The Toronto Alexithymia Scale 20-item (TAS-20) |
It is a self-report instrument that measures both a global factor of alexithymia, and three specific domains: Difficulty in Identifying Feelings (7 items), Difficulty in Describing Feelings (5 items) and Externally Oriented Thinking (8 items). Items are rated on a 5-point Likert scale. The total scale score ranges between 20 and 100, with higher scores indicating greater level of alexithymia |
8 months |
|
| Secondary |
The Reflective Functioning Questionnaire (RFQ-8) |
It is an 8-item self-report instrument, rated on a 7-point Likert scale, that assesses the degree of certainty or uncertainty about their own or someone else's mental states. It includes two subscales (with a double-scoring procedure): Uncertainty about mental states (5 items, with range 0-3) and Certainty about mental states (6 items, with range 0-2). High levels of certainty about mental states indicate hypermentalizing and high levels of uncertainty indicate hypomentalizing |
Baseline |
|
| Secondary |
The Reflective Functioning Questionnaire (RFQ-8) |
It is an 8-item self-report instrument, rated on a 7-point Likert scale, that assesses the degree of certainty or uncertainty about their own or someone else's mental states. It includes two subscales (with a double-scoring procedure): Uncertainty about mental states (5 items, with range 0-3) and Certainty about mental states (6 items, with range 0-2). High levels of certainty about mental states indicate hypermentalizing and high levels of uncertainty indicate hypomentalizing |
2 months |
|
| Secondary |
The Reflective Functioning Questionnaire (RFQ-8) |
It is an 8-item self-report instrument, rated on a 7-point Likert scale, that assesses the degree of certainty or uncertainty about their own or someone else's mental states. It includes two subscales (with a double-scoring procedure): Uncertainty about mental states (5 items, with range 0-3) and Certainty about mental states (6 items, with range 0-2). High levels of certainty about mental states indicate hypermentalizing and high levels of uncertainty indicate hypomentalizing |
8 months |
|
| Secondary |
The Hospital Anxiety and Depression Scale (HADS) |
It measures anxious and depressive symptomatology. It is a 14-item self-report, rated on a 4-point Likert scale, with a total score (ranging from 0 to 42) and two subscales (7 items each, ranging from 0-21) |
Baseline |
|
| Secondary |
The Hospital Anxiety and Depression Scale (HADS) |
It measures anxious and depressive symptomatology. It is a 14-item self-report, rated on a 4-point Likert scale, with a total score (ranging from 0 to 42) and two subscales (7 items each, ranging from 0-21) |
2 months |
|
| Secondary |
The Hospital Anxiety and Depression Scale (HADS) |
It measures anxious and depressive symptomatology. It is a 14-item self-report, rated on a 4-point Likert scale, with a total score (ranging from 0 to 42) and two subscales (7 items each, ranging from 0-21) |
8 months |
|
| Secondary |
The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) |
It is a self-report instrument of 26 items grouped into general health questions (2 items) and four factors: Physical Health (7 items), Psychological Health (6 items), Social Relations (3 items) and Environment (8 items), ranging from 0 to 100 points. Higher scores in each domain indicate higher level of satisfaction |
Baseline |
|
| Secondary |
The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) |
It is a self-report instrument of 26 items grouped into general health questions (2 items) and four factors: Physical Health (7 items), Psychological Health (6 items), Social Relations (3 items) and Environment (8 items), ranging from 0 to 100 points. Higher scores in each domain indicate higher level of satisfaction |
2 months |
|
| Secondary |
The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) |
It is a self-report instrument of 26 items grouped into general health questions (2 items) and four factors: Physical Health (7 items), Psychological Health (6 items), Social Relations (3 items) and Environment (8 items), ranging from 0 to 100 points. Higher scores in each domain indicate higher level of satisfaction |
8 months |
|
