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CompletedNCT05656456COVIDOCSUpdated Dec 19, 2022

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

An observational study in Obsessive-Compulsive Disorder, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • Family accommodation
  • Covid-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 75 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not speaking fluently Dutch
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • OCD patients

    Patients with obsessive-compulsive disorder

    Other: Y-BOCS or FAS online survey, interview

  • live-in family members

    Live-in family members of OCD patients

    Other: Y-BOCS or FAS online survey, interview

Interventions

  • OtherY-BOCS or FAS online survey, interview

    Y-BOCS or FAS and online survey will be administered interview will be conducted

06

What researchers measure

Primary outcomes

  1. OCD symptoms in patients at baseline

    OCD symptoms as measured by the Y-BOCS

    Time frame: Baseline

  2. Family accommodation in family members at baseline

    FA as measured by the family accommodation scale (FAS)

    Time frame: Baseline

  3. Change in OCD symptoms in patients

    OCD symptoms as measured by the Y-BOCS

    Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days

  4. Change in family accommodation in family members

    FA as measured by the family accommodation scale (FAS)

    Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: Baseline + 30 days, baseline + 90 days, baseline + 180 days

07

Study locations

1 site
  • Ghent University Hospital
    Ghent, 9000, Belgium
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05656456
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Dec 19, 2022
Start date
Apr 6, 2020
Primary completion
Nov 22, 2020
Completion
Nov 22, 2020
Last update
Dec 19, 2022

Study contacts

Gilbert MD Lemmens, MD, PhD
study director · University Hospital, Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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