NCT05656456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

December 15, 2022

Last Update Submit

December 15, 2022

Conditions

Obsessive-Compulsive Disorder

Keywords

Family accommodationCovid-19

Outcome Measures

Primary Outcomes (4)

  • OCD symptoms in patients at baseline

    OCD symptoms as measured by the Y-BOCS

    Baseline

  • Family accommodation in family members at baseline

    FA as measured by the family accommodation scale (FAS)

    Baseline

  • Change in OCD symptoms in patients

    OCD symptoms as measured by the Y-BOCS

    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)

    Baseline + 30 days, baseline + 90 days, baseline + 180 days

Secondary Outcomes (8)

  • Depressive symptoms at baseline in patients and family members

    Baseline

  • Change in depressive symptoms in patients and family members

    Baseline + 30 days, baseline + 90 days, baseline + 180 days

  • Anxiety symptoms at baseline in patients and family members

    Baseline

  • Change in anxiety symptoms in patients and family members

    Baseline + 30 days, baseline + 90 days, baseline + 180 days

  • Stress levels at baseline in patients and family members

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

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

Y-BOCS or FAS online survey, interviewOTHER

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

OCD patientslive-in family members

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • not speaking fluently Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderCOVID-19

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gilbert MD Lemmens, MD, PhD

    University Hospital, Ghent

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

December 19, 2022

Study Start

April 6, 2020

Primary Completion

November 22, 2020

Study Completion

November 22, 2020

Last Updated

December 19, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)