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NCT Number: NCT05656456

Impact of COVID-19 on Mental Health of OCD Patients and 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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not speaking fluently Dutch

Treatment and study plan

Y-BOCS or FAS online survey, interview

Other

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

Primary outcomes

  1. OCD symptoms in patients at baseline

    Time frame: Baseline

    OCD symptoms as measured by the Y-BOCS

  2. Family accommodation in family members at baseline

    Time frame: Baseline

    FA as measured by the family accommodation scale (FAS)

  3. 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

  4. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: COVIDOCS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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