Trial Outcomes & Findings for The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology (NCT NCT04694482)
NCT ID: NCT04694482
Last Updated: 2023-09-07
Results Overview
Range 0-126. Higher scores mean worse outcome. This psychometric scale measures the global psychopathology investigating several psychopathological areas (anxiety, thinking, mood, perception, etc.). It provides a global score of severity (\> 31 means that the patient need hospitalization).
COMPLETED
270 participants
2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
2023-09-07
Participant Flow
Participant milestones
| Measure |
Psychiatric Patients
Patients with different psychiatric diagnoses are included. All the psychometric scales are administered.
PTSD symptoms are assessed using a specific scale (IES-R) and compared with healthy controls
|
Healthy Controls
PTSD symptoms are assessed using a specific scale (IES-R) and compared with psychiatric patients.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
70
|
|
Overall Study
COMPLETED
|
166
|
57
|
|
Overall Study
NOT COMPLETED
|
34
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Psychiatric Patients
n=166 Participants
Patients with different psychiatric diagnoses are included. All the psychometric scales are administered.
PTSD symptoms are assessed using a specific scale (IES-R) and compared with healthy controls.
|
Healthy Controls
n=57 Participants
PTSD symptoms are assessed using a specific scale (IES-R) and compared with psychiatric patients.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.22 years
STANDARD_DEVIATION 14.23 • n=166 Participants
|
43.86 years
STANDARD_DEVIATION 15.19 • n=57 Participants
|
47.85 years
STANDARD_DEVIATION 14.64 • n=223 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=166 Participants
|
32 Participants
n=57 Participants
|
111 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=166 Participants
|
25 Participants
n=57 Participants
|
112 Participants
n=223 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
166 participants
n=166 Participants
|
57 participants
n=57 Participants
|
223 participants
n=223 Participants
|
|
Education
Primary school
|
11 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
11 Participants
n=223 Participants
|
|
Education
Secondary school
|
69 Participants
n=166 Participants
|
2 Participants
n=57 Participants
|
71 Participants
n=223 Participants
|
|
Education
High school
|
77 Participants
n=166 Participants
|
15 Participants
n=57 Participants
|
92 Participants
n=223 Participants
|
|
Education
Graduate
|
9 Participants
n=166 Participants
|
28 Participants
n=57 Participants
|
37 Participants
n=223 Participants
|
|
Education
Post-graduate
|
0 Participants
n=166 Participants
|
12 Participants
n=57 Participants
|
12 Participants
n=223 Participants
|
|
Marital status
Single
|
92 Participants
n=166 Participants
|
13 Participants
n=57 Participants
|
105 Participants
n=223 Participants
|
|
Marital status
Married/cohabitant
|
46 Participants
n=166 Participants
|
40 Participants
n=57 Participants
|
86 Participants
n=223 Participants
|
|
Marital status
Separated/divorced
|
23 Participants
n=166 Participants
|
2 Participants
n=57 Participants
|
25 Participants
n=223 Participants
|
|
Marital status
Widower
|
5 Participants
n=166 Participants
|
2 Participants
n=57 Participants
|
7 Participants
n=223 Participants
|
|
Occupational status
Employed
|
45 Participants
n=166 Participants
|
45 Participants
n=57 Participants
|
90 Participants
n=223 Participants
|
|
Occupational status
Unemployed
|
27 Participants
n=166 Participants
|
5 Participants
n=57 Participants
|
32 Participants
n=223 Participants
|
|
Occupational status
Never-before-employed
|
3 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
3 Participants
n=223 Participants
|
|
Occupational status
Invalid-at-work
|
75 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
75 Participants
n=223 Participants
|
|
Occupational status
Retired
|
16 Participants
n=166 Participants
|
7 Participants
n=57 Participants
|
23 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
None
|
81 Participants
n=166 Participants
|
44 Participants
n=57 Participants
|
125 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Schizophrenia
|
19 Participants
n=166 Participants
|
2 Participants
n=57 Participants
|
21 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Bipolar Disorder
|
6 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
6 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Major Depressive Disorder
|
33 Participants
n=166 Participants
|
10 Participants
n=57 Participants
|
43 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Anxiety disorders
|
13 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
13 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Eating disorder
|
2 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
2 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Drug abuse
|
6 Participants
n=166 Participants
|
1 Participants
n=57 Participants
|
7 Participants
n=223 Participants
|
|
Family history of psychiatric disorders
Personality Disorders
|
6 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
6 Participants
n=223 Participants
|
|
Substance abuse
None
|
119 Participants
n=166 Participants
|
49 Participants
n=57 Participants
|
168 Participants
n=223 Participants
|
|
Substance abuse
Alcohol
|
15 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
15 Participants
n=223 Participants
|
|
Substance abuse
Cannabis
|
17 Participants
n=166 Participants
|
7 Participants
n=57 Participants
|
24 Participants
n=223 Participants
|
|
Substance abuse
Cocaine
|
8 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
8 Participants
n=223 Participants
|
|
Substance abuse
Heroin
|
4 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
4 Participants
n=223 Participants
|
|
Substance abuse
Benzodiazepines
|
1 Participants
n=166 Participants
|
1 Participants
n=57 Participants
|
2 Participants
n=223 Participants
|
|
Substance abuse
Gambling
|
2 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
2 Participants
n=223 Participants
|
|
Medical comorbility
Yes
|
86 Participants
n=166 Participants
|
12 Participants
n=57 Participants
|
98 Participants
n=223 Participants
|
|
Medical comorbility
No
|
80 Participants
n=166 Participants
|
45 Participants
n=57 Participants
|
125 Participants
n=223 Participants
|
|
6-months pre-COVID poly-abuse
Yes
|
18 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
18 Participants
n=223 Participants
|
|
6-months pre-COVID poly-abuse
No
|
148 Participants
n=166 Participants
|
57 Participants
n=57 Participants
|
205 Participants
n=223 Participants
|
|
6-months post-COVID poly-abuse
Yes
|
8 Participants
n=166 Participants
|
0 Participants
n=57 Participants
|
8 Participants
n=223 Participants
|
|
6-months post-COVID poly-abuse
No
|
158 Participants
n=166 Participants
|
57 Participants
n=57 Participants
|
215 Participants
n=223 Participants
|
|
Presence of 2 COVID symptoms
Yes
|
5 Participants
n=166 Participants
|
20 Participants
n=57 Participants
|
25 Participants
n=223 Participants
|
|
Presence of 2 COVID symptoms
No
|
161 Participants
n=166 Participants
|
37 Participants
n=57 Participants
|
198 Participants
n=223 Participants
|
|
Medical poly-comorbility
Yes
|
57 Participants
n=166 Participants
|
4 Participants
n=57 Participants
|
61 Participants
n=223 Participants
|
|
Medical poly-comorbility
No
|
109 Participants
n=166 Participants
|
53 Participants
n=57 Participants
|
162 Participants
n=223 Participants
|
PRIMARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
Range 0-126. Higher scores mean worse outcome. This psychometric scale measures the global psychopathology investigating several psychopathological areas (anxiety, thinking, mood, perception, etc.). It provides a global score of severity (\> 31 means that the patient need hospitalization).
Outcome measures
| Measure |
Psychiatric Patients
n=166 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS)
T0
|
29.30 score on a scale
Standard Deviation 10.41
|
—
|
|
Brief Psychiatric Rating Scale (BPRS)
T1
|
32.80 score on a scale
Standard Deviation 11.04
|
—
|
|
Brief Psychiatric Rating Scale (BPRS)
T2
|
30.25 score on a scale
Standard Deviation 9.4
|
—
|
PRIMARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
Range 0-7. Higher scores mean worse outcome. The severity subscale measures the global severity of symptom presentation based on the clinicians' evaluation (Normal, Borderline mentally ill, Mildly ill, etc.).
Outcome measures
| Measure |
Psychiatric Patients
n=166 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Clinical Global Impression (CGI) Severity Subscale
T0
|
4.02 score on a scale
Standard Deviation 1.31
|
—
|
|
Clinical Global Impression (CGI) Severity Subscale
T1
|
4.23 score on a scale
Standard Deviation 1.29
|
—
|
|
Clinical Global Impression (CGI) Severity Subscale
T2
|
4.10 score on a scale
Standard Deviation 1.31
|
—
|
PRIMARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
Range 0-7. Higher scores mean worse outcome. The improvement subscale measures the clinical improvement (how much has the patient changed) according to the clinician's judgement. It results as: very much improved, much improved, minimally improved, no changed, minimally worse, etc.).
Outcome measures
| Measure |
Psychiatric Patients
n=166 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Clinical Global Impression (CGI) Improvement Subscale
T2
|
3.61 score on a scale
Standard Deviation 0.91
|
—
|
|
Clinical Global Impression (CGI) Improvement Subscale
T1
|
4.37 score on a scale
Standard Deviation 0.97
|
—
|
PRIMARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
Range 0-56. Higher scores mean worse outcome. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Outcome measures
| Measure |
Psychiatric Patients
n=166 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Hamilton Anxiety Scale (HAM-A)
T0
|
6.81 score on a scale
Standard Deviation 8.13
|
—
|
|
Hamilton Anxiety Scale (HAM-A)
T1
|
10.03 score on a scale
Standard Deviation 9.02
|
—
|
|
Hamilton Anxiety Scale (HAM-A)
T2
|
7.92 score on a scale
Standard Deviation 8.71
|
—
|
PRIMARY outcome
Timeframe: 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Both psychiatric patients and healthy controls were assessed for this outcome.
Range 0-88. Higher scores mean worse outcome. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. It comprises 3 subscales representative of the major symptom clusters of post-traumatic stress: intrusion, avoidance, and hyper-arousal.
Outcome measures
| Measure |
Psychiatric Patients
n=166 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
n=57 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Impact of Event Scale - Revised Version (IES-R)
T1
|
20.18 score on a scale
Standard Deviation 18.29
|
24.34 score on a scale
Standard Deviation 12.91
|
|
Impact of Event Scale - Revised Version (IES-R)
T2
|
13.47 score on a scale
Standard Deviation 15.15
|
20.57 score on a scale
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
Range 0-30. Higher scores mean worse outcome. The scale includes 3 self-rated items designed to measure the extent to which 3 major domains (work 0-10, social life/leisure activities 0-10, and family life/home responsibilities 0-10) in the patient's life are functionally impaired by psychiatric or medical symptoms. For each subscale, higher scores mean better outcome. Subscales are summed to compute a total score.
Outcome measures
| Measure |
Psychiatric Patients
n=166 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Disability Scale (DISS)
T2
|
17.25 score on a scale
Standard Deviation 8.01
|
—
|
|
Disability Scale (DISS)
T0
|
17.95 score on a scale
Standard Deviation 7.90
|
—
|
|
Disability Scale (DISS)
T1
|
17.50 score on a scale
Standard Deviation 7.57
|
—
|
SECONDARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only bipolar and major depressed patients were assessed for this outcome; data not collected for healthy controls.
Range 0-67. Higher scores mean worse outcome. The scale measures the severity of depressive symptoms taking into account anxiety and somatic manifestations.
Outcome measures
| Measure |
Psychiatric Patients
n=65 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
T0
|
7.42 score on a scale
Standard Deviation 6.44
|
—
|
|
Hamilton Depression Rating Scale (HAM-D)
T1
|
12.57 score on a scale
Standard Deviation 12.45
|
—
|
|
Hamilton Depression Rating Scale (HAM-D)
T2
|
8.03 score on a scale
Standard Deviation 6.90
|
—
|
SECONDARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only bipolar and major depressed patients were assessed for this outcome; data not collected for healthy controls.
Range 0-60. Higher scores mean worse outcome. The scale measures the core symptoms of depression (e.g. anhedonia).
Outcome measures
| Measure |
Psychiatric Patients
n=65 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Montgomery and Asberg Depression Rating Scale (MADRS)
T0
|
9.45 score on a scale
Standard Deviation 8.52
|
—
|
|
Montgomery and Asberg Depression Rating Scale (MADRS)
T1
|
12.91 score on a scale
Standard Deviation 9.52
|
—
|
|
Montgomery and Asberg Depression Rating Scale (MADRS)
T2
|
9.69 score on a scale
Standard Deviation 8.32
|
—
|
SECONDARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only bipolar patients were assessed for this outcome; data not collected for healthy controls.
Range 0-56. Higher scores mean worse outcome. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition, and generally limited to the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.
Outcome measures
| Measure |
Psychiatric Patients
n=29 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
T2
|
3.51 score on a scale
Standard Deviation 7.04
|
—
|
|
Young Mania Rating Scale (YMRS)
T0
|
3.14 score on a scale
Standard Deviation 5.84
|
—
|
|
Young Mania Rating Scale (YMRS)
T1
|
4.69 score on a scale
Standard Deviation 9.04
|
—
|
SECONDARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only Obsessive-Compulsive patients were assessed for this outcome; data not collected for healthy controls.
Range 0-40. Higher scores mean worse outcome. The scale is a semi-structured interview that consists of 10 core items, 5 measuring time, interference, distress, resistance and control of obsessions (items: 1-5), and 5 identical items measuring compulsions (items: 6-10). The items are rated from 0 (no symptoms) to 4 (severe symptoms), and yield a global severity score (range 0-40).
Outcome measures
| Measure |
Psychiatric Patients
n=7 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
T0
|
9.20 score on a scale
Standard Deviation 10.00
|
—
|
|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
T1
|
10.40 score on a scale
Standard Deviation 10.87
|
—
|
|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
T2
|
10.20 score on a scale
Standard Deviation 11.49
|
—
|
SECONDARY outcome
Timeframe: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)Population: Only Schizophrenia patients were assessed for this outcome; data not collected for healthy controls.
Range 30-210. Higher scores mean worse outcome. The scale is a medical scale used for measuring symptom severity of patients with schizophrenia. It assesses positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers.
Outcome measures
| Measure |
Psychiatric Patients
n=66 Participants
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Healthy Controls
Psychometric scales
Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
|---|---|---|
|
Positive And Negative Syndrome Scale (PANSS)
T0
|
60.72 score on a scale
Standard Deviation 27.33
|
—
|
|
Positive And Negative Syndrome Scale (PANSS)
T1
|
62.49 score on a scale
Standard Deviation 32.96
|
—
|
|
Positive And Negative Syndrome Scale (PANSS)
T2
|
62.63 score on a scale
Standard Deviation 25.85
|
—
|
Adverse Events
Psychiatric Patients
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place