Family Involvement in CBGT of OCD: a Randomized Controlled Trial

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Impact of Involvement of the Family in the Cognitive Behavioral Group Therapy for Obsessive-Compulsive Disorder: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071990
• Other study ID #: EC/2019/0419
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Hannelore LN Tandt, MD
• Phone: +3293324394
• Email: hannelore.tandt[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• FB-CBGT
CBGT for OCD patients, with Involvement of family members (partner, parent, sibling, ...)
• CBGT
CBGT for OCD patients, without involvement of family members

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	A reduction in anxiety and depression in patients and family members	The Hospital Anxiety and Depressive Scale (HADS) will be used to measure the presence of depression and anxiety and changes in depression and anxiety rates	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
Secondary	Increase of quality of life (QOL) in patients	The Quality of Life Questionnaire (WHOQOL-BREF) will be administered to assess the perceived quality of life and emotional well-being 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
Secondary	An improvement in family functioning measured by the SCORE-15 in patients and family members	The Systemic Clinical Outcome and Routine Evaluation 15-item version (SCORE-15) will be administered to assess the outcome in systemic family therapy and other family-oriented services	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
Secondary	An improvement in family functioning measured by the BPNSFS in patients and family members	The Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS) -addresses both need satisfaction and frustration in relationships. Whereas need satisfaction is associated with well-being, need frustration is associated with ill-being. Self-determination theory posits three universal psychological needs: autonomy; competence; and relatedness, and suggests that these must be present satisfactorily for people to maintain optimal performance and well-being.	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
Secondary	An improvement in family functioning measured by the perceived criticism measure (PCM) in patients and family members	The perceived criticism measure (PCM) consists of a 10-point Likert-type scale to describe a relative's degree of criticism of him of her. The patients' perception on their relatives' behavior may be the proximal factor in expressed emotions relationship to treatment response and relapse. This measure proved to be a strong predictor of outcome for outpatients with OCD.	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
Secondary	A decrease of burden in family members	Family burden will be evaluated with the Zarit Burden Interview (ZBI) 22-item version, a self-report measure. The ZBI assesses the perceived burden in the caregivers of patients with psychiatric disorders.	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
Secondary	Evaluation therapeutic sessions	In order to assess how patients and family members evaluate the therapeutic relation, goals and topics, approach during the therapeutic session the Session Rating Scale (SRS V.3.0) will be administered.	The SRS will be completed at 12 time-points: after all therapeutic sessions, 12 sessions in total, during 3 months