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Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537795
Recruitment Status : Unknown
Verified August 2015 by Universitaire Ziekenhuizen KU Leuven.
Recruitment status was:  Recruiting
First Posted : September 2, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Study Description
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Brief Summary:
In this study the investigators will use semi-structured interviews to qualitatively analyse patient and family member experiences with either deep brain stimulation or other forms of psychiatric neurosurgery.

Condition or disease Intervention/treatment
Obsessive-Compulsive Disorder Device: deep brain stimulation Procedure: anterior capsulotomy

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
Study Start Date : August 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Deep Brain Stimulation Patients
Patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group
 Device: deep brain stimulation
Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis
Deep Brain Stimulation Family Members
Family members of patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group
Anterior Capsulotomy Patients
Patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group
 Procedure: anterior capsulotomy
Anterior Capsulotomy Family Members
Family members of patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group


Outcome Measures
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Primary Outcome Measures :
  1. Semi-structured Interview [ Time Frame: up to 180 months after surgery ]
    A semi-structured interview of patients and one of their family members will be conducted. Patients and family members will be interviewed separately. The interview will consist of several open ended questions around several themes. The interviews for patients and family members will have their own focus. Patient interviews will focus on living with OCD, living with PNS and the decision making process leading to the PNS procedure. Family member interviews will focus on their own experience in their interaction with OCD patients both before and after PNS


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In the University Hospital of Leuven, more than thirty patients suffering from severe OCD have been treated with DBS. The investigators will ask patients who are currently being treated with DBS whether they are willing to participate in this study. The investigators will also ask whether one of their family members might participate, preferentially their partner or another close family member. The aim is to include at least ten patients and their family members. OCD patients, who have been treated with anterior capsulotomy, and their family members will also be asked for participation in this study. The aim is to also include ten patients and family members in this group.
Criteria

Inclusion Criteria:

  • (family member of) patient who has previously been treated with deep brain stimulation or anterior capsulotomy

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537795


Contacts
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Contact: Simon Raymaekers, MD 003216342690 simon.raymaekers@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Simon Raymaekers, MD    003216342690      
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Investigators
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Principal Investigator: Chris Bervoets, MD, PhD UPC KU Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT02537795    
Other Study ID Numbers: s58187
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: August 2015
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
Deep Brain Stimulation
Anterior Capsulotomy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders