Family Involvement in CBGT of OCD: a Randomized Controlled Trial

December 8, 2023 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: FB-CBGT
CBGT for OCD patients, with Involvement of family members (partner, parent, sibling, ...)
Placebo Comparator: 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.
Behavioral: CBGT
CBGT for OCD patients, without involvement of family members

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Faster decrease and longer lasting improvement (less relapse) of OCD symptoms in patients
Time Frame: 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
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
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A reduction in anxiety and depression in patients and family members
Time Frame: 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
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
Increase of quality of life (QOL) in patients
Time Frame: 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
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
An improvement in family functioning measured by the SCORE-15 in patients and family members
Time Frame: 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
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
An improvement in family functioning measured by the BPNSFS in patients and family members
Time Frame: 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
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
An improvement in family functioning measured by the perceived criticism measure (PCM) in patients and family members
Time Frame: 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
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
A decrease of burden in family members
Time Frame: 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
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
Evaluation therapeutic sessions
Time Frame: The SRS will be completed at 12 time-points: after all therapeutic sessions, 12 sessions in total, during 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilbert MD Lemmens, MD, PhD, Ghent University Hospital, University Ghent
  • Principal Investigator: Kurt Audenaert, MD, PhD, Ghent University Hospital, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC/2019/0419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality issues but are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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