Clinical trial NCT04071990: Family Involvement in CBGT of OCD: a Randomized Controlled Trial
Official title: Impact of Involvement of the Family in the Cognitive Behavioral Group Therapy for Obsessive-Compulsive Disorder: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Family based intervention
Cognitive behavioral group therapy
Exposure and response prevention
Family accommodation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Faster decrease and longer lasting improvement (less relapse) of OCD symptoms in patients
timeFrame: 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
measure: Faster decrease and longer lasting improvement of family accommodation in family members
timeFrame: 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:
measure: A reduction in anxiety and depression in patients and family members
timeFrame: 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
measure: Increase of quality of life (QOL) in patients
timeFrame: 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
measure: An improvement in family functioning measured by the SCORE-15 in patients and family members
timeFrame: 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
measure: An improvement in family functioning measured by the BPNSFS in patients and family members
timeFrame: 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
measure: An improvement in family functioning measured by the perceived criticism measure (PCM) in patients and family members
timeFrame: 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
measure: A decrease of burden in family members
timeFrame: The ZBI 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
measure: Evaluation therapeutic sessions
timeFrame: The SRS will be completed at 12 time-points: after all therapeutic sessions, 12 sessions in total, during 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: Ghent University Hospital, University Ghent
name: Gilbert MD Lemmens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghent University Hospital, University Ghent
name: Kurt Audenaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: