Obsessive-Compulsive DisorderNCT04071990
Family Involvement in CBGT of OCD: a Randomized Controlled Trial
A study testing FB-CBGT and CBGT in people with Obsessive-Compulsive Disorder, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- FB-CBGT and CBGT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Sep 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- current severe suicidality
- current substance abuse
- psychotic symptoms and
- OCD treated with deep brain stimulation
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Hannelore LN Tandt, MD, +3293324394, hannelore.tandt@uzgent.be
Gilbert MD Lemmens, MD, PhD, +3293324394, gilbert.lemmens@ugent.be
About this study
Official title: 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.
Read the 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
- Being tested
- FB-CBGT, CBGT
- Keywords
- Family based intervention, Cognitive behavioral group therapy, Exposure and response prevention, Family accommodation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB-CBGTBehavioural
CBGT for OCD patients, with Involvement of family members (partner, parent, sibling, ...)
CBGTBehavioural
CBGT for OCD patients, without involvement of family members
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CBGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faster decrease and longer lasting improvement (less relapse) of OCD symptoms in patients
Improvement of OCD symptoms will be measured by the Y-BOCS
Measured: 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)
Measured: 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 Hospital Anxiety and Depressive Scale (HADS) will be used to measure the presence of depression and anxiety and changes in depression and anxiety rates
Measured: 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 Quality of Life Questionnaire (WHOQOL-BREF) will be administered to assess the perceived quality of life and emotional well-being in patients
Measured: 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 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
Measured: 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 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.
Measured: 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 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.
Measured: 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
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.
Measured: 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
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.
Measured: The SRS will be completed at 12 time-points: after all therapeutic sessions, 12 sessions in total, during 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start3 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert MD Lemmens, MD, PhD, Principal investigator, Ghent University Hospital, University GhentKurt Audenaert, MD, PhD, Principal investigator, Ghent University Hospital, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071990
- Sponsor's protocol ID
- BC-5080
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Involvement of the Family in the Cognitive Behavioral Group Therapy for Obsessive-Compulsive Disorder: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04071990
- Acronym / sponsor ID
- BC-5080
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Family based intervention, Cognitive behavioral group therapy, Exposure and response prevention, Family accommodation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Family-based cognitive behavioral group therapy (FB-CBGT) | Active comparator | Behavioral: FB-CBGTOne 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. |
| Cognitive-behavioral group therapy (CBGT) without family | Placebo comparator | Behavioral: CBGTEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- current severe suicidality
- current substance abuse
- psychotic symptoms and
- OCD treated with deep brain stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB-CBGTCBGT for OCD patients, with Involvement of family members (partner, parent, sibling, ...) | Behavioural | Family-based cognitive behavioral group therapy (FB-CBGT) |
| CBGTCBGT for OCD patients, without involvement of family members | Behavioural | Cognitive-behavioral group therapy (CBGT) without family |
Primary outcome
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
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)
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert MD Lemmens, MD, PhD principal investigator
Ghent University Hospital, University Ghent
Kurt Audenaert, MD, PhD principal investigator
Ghent University Hospital, University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FB-CBGT and CBGT in people with Obsessive-Compulsive Disorder, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannelore LN Tandt, MD (+3293324394, hannelore.tandt@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.