Family Involvement in CBGT of OCD: a Randomized Controlled Trial

NCT04071990 | Recruiting

• 1 other identifier: BC-5080
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Family based intervention; Cognitive behavioral group therapy; Exposure and response prevention; Family accommodation

Outcome Measures

Primary Outcomes (2)

• Faster decrease and longer lasting improvement (less relapse) of OCD symptoms in patients

  Improvement of OCD symptoms will be measured by the Y-BOCS

  Y-BOCS will be completed at four time-points: at inclusion, after completion of the CBGT (an average of 3 months post baseline) and at 6 and 12 months post CBGT

• Faster decrease and longer lasting improvement of family accommodation in family members

  Improvement of family accommodation will be measured by the family accommodation scale (FAS)

  The Family Accommodation Scale (FAS) will be completed at four time-points: at inclusion, after completion of the CBGT (an average of 3 months post baseline) and at 6 and 12 months post CBGT

Secondary Outcomes (7)

• A reduction in anxiety and depression in patients and family members

  The HADS will be completed at four time-points: at inclusion, after completion of the CBGT (an average of 3 months post baseline) and at 6 and 12 months post CBGT

• Increase of quality of life (QOL) in patients

  The WHOQOL-BREF will be completed at four time-points: at inclusion, after completion of the CBGT (an average of 3 months post baseline) and at 6 and 12 months post CBGT

• An improvement in family functioning measured by the SCORE-15 in patients and family members

  The SCORE-15 will be completed at four time-points: at inclusion, after completion of the CBGT(an average of 3 months post baseline) and at 6 and 12 months post CBGT

• An improvement in family functioning measured by the BPNSFS in patients and family members

  The BPNSFS will be completed at four time-points: at inclusion, after completion of the CBGT (an average of 3 months post baseline) and at 6 and 12 months post CBGT

• An improvement in family functioning measured by the perceived criticism measure (PCM) in patients and family members

  The PCM will be completed at four time-points: at inclusion, after completion of the CBGT (an average of 3 months post baseline) and at 6 and 12 months post CBGT

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Behavioral: FB-CBGT

Cognitive-behavioral group therapy (CBGT) without family

PLACEBO COMPARATOR

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.

Behavioral: CBGT

Interventions

FB-CBGT BEHAVIORAL

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

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

CBGT BEHAVIORAL

CBGT for OCD patients, without involvement of family members

Cognitive-behavioral group therapy (CBGT) without family

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gilbert MD Lemmens, MD, PhD

  Ghent University Hospital, University Ghent

  PRINCIPAL INVESTIGATOR

• Kurt Audenaert, MD, PhD

  Ghent University Hospital, University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannelore LN Tandt, MD

CONTACT

+3293324394; hannelore.tandt@uzgent.be

Gilbert MD Lemmens, MD, PhD

CONTACT

+3293324394; gilbert.lemmens@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After randomization the patient an family member will be allocated to one of the two groups: (a) CBGT with involvement of family (intervention) or (b) CBGT without involvement of family (control), both groups will exist of 12 sessions

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 28, 2019
• Study Start: September 3, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)