- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656456
Impact of COVID-19 on Mental Health of OCD Patients and live-in Family Members (COVIDOCS)
The Impact of the COVID-19 Pandemic on Patients With Obsessive-Compulsive Disorder and Their live-in Family Members
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The impact of the current Covid-19 pandemic on mental health of people with preexisting psychiatric problems is enormous. Previous studies during the SARS outbreak demonstrated a significant burden and increase of mental health problems in people with preexisting psychiatric problems, but little is known about the impact on preexisting obsessive-compulsive disorder (OCD). This longitudinal study aims to investigate the prevalence of mental health problems of OCD patients during and after the Covid-19 pandemic. We also want to investigate the impact on family accommodation (FA). There is growing evidence that FA maintains and/or facilitates OCD symptoms. OCD patients and their live-in family members, followed at the Centre for OCD of the Ghent university hospital, will be included. Sociodemographic data, data regarding employment and previous mental health problems will be collected at the first survey. The Y-BOCS (OCD symtoms) and FAS (family accommodation) will be taken from patients and family members respectively at the start, after 1, 3 and 6 months. The Depression, Anxiety and Stress Scale (DASS-21), the Dutch translation of the Covid-19 Peritraumatic Distress Index (CPDI) will be administered at the same time points through an online survey.
Secondly, patients and live-in family members will be interviewed about their experiences concerning the covid pandemic, the isolation measures, media exposure and change of mental health practice and the impact on the OCD (qualitative research).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ghent, Belgium, 9000
- Ghent University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- OCD patients
- live-in family members of OCD patients
Exclusion Criteria:
- not speaking fluently Dutch
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
OCD patients
Patients with obsessive-compulsive disorder
|
Y-BOCS or FAS and online survey will be administered interview will be conducted
|
live-in family members
Live-in family members of OCD patients
|
Y-BOCS or FAS and online survey will be administered interview will be conducted
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OCD symptoms in patients at baseline
Time Frame: Baseline
|
OCD symptoms as measured by the Y-BOCS
|
Baseline
|
Family accommodation in family members at baseline
Time Frame: Baseline
|
FA as measured by the family accommodation scale (FAS)
|
Baseline
|
Change in OCD symptoms in patients
Time Frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
OCD symptoms as measured by the Y-BOCS
|
Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
Change in family accommodation in family members
Time Frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
FA as measured by the family accommodation scale (FAS)
|
Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms at baseline in patients and family members
Time Frame: Baseline
|
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
|
Change in depressive symptoms in patients and family members
Time Frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
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
|
Anxiety symptoms at baseline in patients and family members
Time Frame: Baseline
|
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
|
Change in anxiety symptoms in patients and family members
Time Frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
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
|
Stress levels at baseline in patients and family members
Time Frame: Baseline
|
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
|
Change in stress levels in patients and family members
Time Frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
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
|
Covid-19 related psychological stress at baseline in patients and family members
Time Frame: Baseline
|
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
|
Change in Covid-19 related psychological stress in patients and family members
Time Frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gilbert MD Lemmens, MD, PhD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Personality Disorders
- Anxiety Disorders
- COVID-19
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
Other Study ID Numbers
- BC-07561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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