Family Involvement in CBGT of OCD: a Randomized Controlled Trial

NCT ID: NCT04071990

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

Participants will be recruited at the Centre for OCD at the Ghent University Hospital (UZ Gent) located in Belgium. A group of 80 patients and 80 live-in family members (partner, parent, sibling), between 18 and 65 years old. The patients with OCD will be selected based on the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for obsessive-compulsive disorder using the semi-structured Mini International Neuropsychiatric Interview (MINI screening version 7.0.2)(60). Other inclusion criteria are (a) the OCD patient with a score of at least 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), (b) patient and family member fluent in Dutch and (c) both willing to attend all treatment sessions together. To maximize the generalizability of our sample, we did not exclude patients if they had comorbid mood or anxiety disorders, as long as OCD was the principal diagnosis. Patients and family members will be recruited before randomization, because the aim of this study is to investigate the impact of the involvement of the family in the CBGT. At the start of the experiment we will ask patients and their family members to sign the informed consent. Randomization occurs after oral and written informed consent and patients and family members will be notified about the treatment condition after randomization. After randomization the patient and family member will be allocated to one of the two treatment arms: (a) CBGT with involvement of family of family-based CBGT (FB-CBGT) (intervention) or (b) CBGT without involvement of family (control). The CBGT program exists of a fixed 12-week protocol, involving psycho-education, exposure and response prevention (ERP), cognitive restructuring, and the discussion about the family system.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Family-based cognitive behavioral group therapy (FB-CBGT)

One family member of each patient will be involved during all 12 CBGT sessions. The CBGT program that will be employed in the present study is a protocoled therapy consisting of psychoeducation, ERP techniques, cognitive tools to change dysfunctional thoughts and beliefs, strategies to prevent relapses, discussion on the family involvement (e.g. FA, burden, …) and homework exercises after each session.

Group Type: ACTIVE_COMPARATOR

FB-CBGT

Intervention Type: BEHAVIORAL

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

Cognitive-behavioral group therapy (CBGT) without family

Each patient will be involved during all 12 CBGT sessions. The CBGT program that will be employed in the present study is a protocoled therapy consisting of psychoeducation, ERP techniques, cognitive tools to change dysfunctional thoughts and beliefs, strategies to prevent relapses, discussion on the family involvement (e.g. FA, burden, …) and homework exercises after each session., without the involvement of family members.

Group Type: PLACEBO_COMPARATOR

CBGT

Intervention Type: BEHAVIORAL

CBGT for OCD patients, without involvement of family members

Interventions

FB-CBGT

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

Intervention Type: BEHAVIORAL

CBGT

CBGT for OCD patients, without involvement of family members

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• the OCD patient with a score of at least 16 on Y-BOCS
• patient and family member fluent in Dutch
• patient and family member both willing to attend all treatment sessions together.

Exclusion Criteria

• current severe suicidality
• current substance abuse
• psychotic symptoms and
• OCD treated with deep brain stimulation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilbert MD Lemmens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hospital, University Ghent

Kurt Audenaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hospital, University Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Hannelore LN Tandt, MD

Role: CONTACT

hannelore.tandt@uzgent.be

+3293324394

Gilbert MD Lemmens, MD, PhD

Role: CONTACT

gilbert.lemmens@uzgent.be

+3293324394

Facility Contacts

Hannelore LN Tandt, MD

Role: primary

hannelore.tandt@uzgent.be

+3293324394

Gilbert MD Lemmens, MD, PhD

Role: backup

gilbert.lemmens@ugent.be

+3293324394

Other Identifiers

BC-5080

Identifier Type: -

Identifier Source: org_study_id