Obsessive-Compulsive Disorder Clinical Trial
— COVIDOCSOfficial title:
The Impact of the COVID-19 Pandemic on Patients With Obsessive-Compulsive Disorder and Their live-in Family Members
NCT number | NCT05656456 |
Other study ID # | BC-07561 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 6, 2020 |
Est. completion date | November 22, 2020 |
Verified date | December 2022 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The impact of the current Covid-19 pandemic on mental health of people with preexisting psychiatric problems is enormous. This longitudinal study investigates the prevalence of mental health problems (obsessive compulsive, or depressive symptoms, anxiety, stress...) of obsessive-compulsive disorder (OCD) patients and their live-in family members. We also aim to investigate the impact of the pandemic, isolation measures, exposure to media and changing therapeutic setting in OCD patients and their live-in family members through qualitative research.
Status | Completed |
Enrollment | 75 |
Est. completion date | November 22, 2020 |
Est. primary completion date | November 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - OCD patients - live-in family members of OCD patients Exclusion Criteria: - not speaking fluently Dutch |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OCD symptoms in patients at baseline | OCD symptoms as measured by the Y-BOCS | Baseline | |
Primary | Family accommodation in family members at baseline | FA as measured by the family accommodation scale (FAS) | Baseline | |
Primary | Change in OCD symptoms in patients | OCD symptoms as measured by the Y-BOCS | Baseline + 30 days, baseline + 90 days, baseline + 180 days | |
Primary | Change in family accommodation in family members | FA as measured by the family accommodation scale (FAS) | Baseline + 30 days, baseline + 90 days, baseline + 180 days | |
Secondary | Depressive symptoms at baseline in patients and family members | Depressive symptoms as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more depressive symptoms with a minimum score of 0 and a maximum score of 21. | Baseline | |
Secondary | Change in depressive symptoms in patients and family members | Depressive symptoms as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more depressive symptoms with a minimum score of 0 and a maximum score of 21. | Baseline + 30 days, baseline + 90 days, baseline + 180 days | |
Secondary | Anxiety symptoms at baseline in patients and family members | Anxiety symptoms as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more anxiety symptoms with a minimum score of 0 and a maximum score of 21. | Baseline | |
Secondary | Change in anxiety symptoms in patients and family members | Anxiety symptoms as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more anxiety symptoms with a minimum score of 0 and a maximum score of 21. | Baseline + 30 days, baseline + 90 days, baseline + 180 days | |
Secondary | Stress levels at baseline in patients and family members | Stress as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more stress levels with a minimum score of 0 and a maximum score of 21. | Baseline | |
Secondary | Change in stress levels in patients and family members | Stress as measured by the 7-item depression subscale of the self-reported 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression). A higher score indicates more stress levels with a minimum score of 0 and a maximum score of 21. | Baseline + 30 days, baseline + 90 days, baseline + 180 days | |
Secondary | Covid-19 related psychological stress at baseline in patients and family members | Specific distress regarding Covid-19 will be measured by the Dutch translation of the COVID-19 Peritraumatic Distress Index (CPDI). This self-reported questionnaire inquires about the frequency of anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behaviour, physical symptoms and loss of social functioning in the past week. The score ranges from 0 to 100, with higher scores indicating more distress. | Baseline | |
Secondary | Change in Covid-19 related psychological stress in patients and family members | Specific distress regarding Covid-19 will be measured by the Dutch translation of the COVID-19 Peritraumatic Distress Index (CPDI). This self-reported questionnaire inquires about the frequency of anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behaviour, physical symptoms and loss of social functioning in the past week. The score ranges from 0 to 100, with higher scores indicating more distress. | Baseline + 30 days, baseline + 90 days, baseline + 180 days |
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