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

December 15, 2022 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

OCD patients followed at the Centre of OCD and their live-in family members

Description

Inclusion Criteria:

  • OCD patients
  • live-in family members of OCD patients

Exclusion Criteria:

  • not speaking fluently Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gilbert MD Lemmens, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2020

Primary Completion (Actual)

November 22, 2020

Study Completion (Actual)

November 22, 2020

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality issues but are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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