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

• ClinicalTrials.gov Identifier: NCT02537795
• Recruitment Status: Unknown
• First Posted: September 2, 2015
• Last Update Posted: January 27, 2016
• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Information provided by (Responsible Party): Universitaire Ziekenhuizen KU Leuven

Tracking Information

• First Submitted Date: August 21, 2015
• First Posted Date: September 2, 2015
• Last Update Posted Date: January 27, 2016
• Study Start Date: August 2015
• Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2015)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
• Official Title: Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Obsessive-Compulsive Disorder

Intervention

• Device: deep brain stimulation
  Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis
• Procedure: anterior capsulotomy

Study Groups/Cohorts

• 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
  Intervention: Device: deep brain stimulation
• 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
  Intervention: 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 1, 2015): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2016
• Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• none

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT02537795
• Other Study ID Numbers: s58187
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Universitaire Ziekenhuizen KU Leuven
• Original Responsible Party: Same as current
• Current Study Sponsor: Universitaire Ziekenhuizen KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chris Bervoets, MD, PhD; UPC KU Leuven

• PRS Account: Universitaire Ziekenhuizen KU Leuven
• Verification Date: August 2015