Obsessive-Compulsive DisorderCOVIDOCSNCT05656456
Impact of COVID-19 on Mental Health of OCD Patients and live-in Family Members
An observational study of Obsessive-Compulsive Disorder, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Y-BOCS or FAS online survey, interview
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Apr 2020to 22 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: OCD patients followed at the Centre of OCD and their live-in family members
Who may be able to join
- OCD patients
- live-in family members of OCD patients
Who cannot join
- not speaking fluently Dutch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Y-BOCS or FAS online survey, interview
- Keywords
- Family accommodation, Covid-19
- Medical subject headings
- Obsessive-Compulsive Disorder, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-BOCS or FAS online survey, interviewOther
Y-BOCS or FAS and online survey will be administered interview will be conducted
| Study group | Role | What they receive |
|---|---|---|
| OCD patients | Patients with obsessive-compulsive disorder Receives: Other: Y-BOCS or FAS online survey, interview | |
| live-in family members | Live-in family members of OCD patients Receives: Other: Y-BOCS or FAS online survey, interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCD symptoms in patients at baseline
OCD symptoms as measured by the Y-BOCS
Measured: Baseline
Family accommodation in family members at baseline
FA as measured by the family accommodation scale (FAS)
Measured: Baseline
Change in OCD symptoms in patients
OCD symptoms as measured by the Y-BOCS
Measured: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Change in family accommodation in family members
FA as measured by the family accommodation scale (FAS)
Measured: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Secondary outcomes (8)
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.
Measured: Baseline
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.
Measured: Baseline + 30 days, baseline + 90 days, baseline + 180 days
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.
Measured: Baseline
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.
Measured: Baseline + 30 days, baseline + 90 days, baseline + 180 days
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.
Measured: Baseline
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.
Measured: Baseline + 30 days, baseline + 90 days, baseline + 180 days
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.
Measured: Baseline
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.
Measured: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start6 Apr 2020
- Primary completion22 Nov 2020
- Study completion22 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert MD Lemmens, MD, PhD, Study director, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656456
- Sponsor's protocol ID
- BC-07561
- Acronym
- COVIDOCS
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Pandemic on Patients With Obsessive-Compulsive Disorder and Their live-in Family Members
- ClinicalTrials.gov ID
- NCT05656456
- Acronym / sponsor ID
- COVIDOCS / BC-07561
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Family accommodation, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 22 Nov 2020 (actual)
- Study completion
- 22 Nov 2020 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCD patients | – | Other: Y-BOCS or FAS online survey, interviewPatients with obsessive-compulsive disorder |
| live-in family members | – | Other: Y-BOCS or FAS online survey, interviewLive-in family members of OCD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OCD patients followed at the Centre of OCD and their live-in family members
Key inclusion criteria (2 listed)
- OCD patients
- live-in family members of OCD patients
Key exclusion criteria (1 listed)
- not speaking fluently Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-BOCS or FAS online survey, interviewY-BOCS or FAS and online survey will be administered interview will be conducted | Other | OCD patients, live-in family members |
Primary outcome
OCD symptoms in patients at baseline
Time frame: Baseline
OCD symptoms as measured by the Y-BOCS
Family accommodation in family members at baseline
Time frame: Baseline
FA as measured by the family accommodation scale (FAS)
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
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)
8 secondary outcomes
Depressive symptoms at baseline in patients and family members
Time frame: Baseline
Change in depressive symptoms in patients and family members
Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Anxiety symptoms at baseline in patients and family members
Time frame: Baseline
Change in anxiety symptoms in patients and family members
Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Stress levels at baseline in patients and family members
Time frame: Baseline
Change in stress levels in patients and family members
Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Covid-19 related psychological stress at baseline in patients and family members
Time frame: Baseline
Change in Covid-19 related psychological stress in patients and family members
Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert MD Lemmens, MD, PhD study director
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCD symptoms in patients at baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.