Impact of COVID-19 on Mental Health of OCD Patients and live-in Family Members

Obsessive-Compulsive Disorder Clinical Trial

— COVIDOCS  

Official title:

The Impact of the COVID-19 Pandemic on Patients With Obsessive-Compulsive Disorder and Their live-in Family Members

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656456
• Other study ID #: BC-07561
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: November 22, 2020

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COVID-19
• Obsessive-Compulsive Disorder

Intervention

Other:
• Y-BOCS or FAS online survey, interview
Y-BOCS or FAS and online survey will be administered interview will be conducted

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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