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Family Involvement in CBGT of OCD: a Randomized Controlled Trial

NCT04071990 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-19

No results posted yet for this study

Summary

With a lifetime prevalence of 1-3% Obsessive-Compulsive Disorder (OCD) is a chronic and disabling psychiatric disorder with considerable burden for the individual and society. Cognitive-behavioural group therapy (CBGT) is effective in reducing the intensity of OCD symptoms and it improves the OCD patient's quality of life. There is also growing evidence that family accommodation (FA) maintains and/or facilitates OCD symptoms, reinforces fear and avoidance behaviours in patients with OCD and is associated with family burden. Considering the promising results of involvement of family in CBGT on OCD symptoms and FA, the current study aims at investigating the effects of the involvement of the family in a 12-week CBGT protocol on the OCD symptoms, FA, burden, QOL, anxiety and depressive symptoms in OCD patients and their live-in relatives. Eighty patients with OCD and their live-in family members (partner, parent, sibling, …) between 18-65 years old will be included in this randomized controlled trial. Patients and family members will be randomly assigned to CBGT with the involvement of family or to CBGT without involvement of family. The primary goal of this study is to evaluate the effects of the involvement of live-in family members during a 12-week CBGT on OCD symptomatology and family accommodation during a 12-month follow-up period. In a secondary stage, we will explore whether the involvement of live-in family members during a 12-week CBGT will ameliorate anxiety and depressive symptoms, QOL, family functioning and burden in the patients and their live-in family.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

BEHAVIORAL

FB-CBGT

CBGT for OCD patients, with Involvement of family members (partner, parent, sibling, ...)

BEHAVIORAL

CBGT

CBGT for OCD patients, without involvement of family members

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Gilbert MD Lemmens, MD, PhD · Ghent University Hospital, University Ghent

  • Kurt Audenaert, MD, PhD · Ghent University Hospital, University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071990 on ClinicalTrials.gov