Mentalizing Education in a Psychiatric Out-patient Clinic | NCT05917535

Studies
Mentalizing Education in a Psychiatric Out-patient Clinic

NCT05917535

Sponsor

University Hospital of North Norway

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

256Estimated

Phase

Not Applicable

Conditions

Mental Health Education

Interventions

Mentalizing course

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Mar 14, 2023

First Submission Date that Met QC Criteria

Jun 23, 2023

First Posted Date

Jun 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2023

Last Update Posted Date

Jun 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Poul Lundgaard Bak, Principal Investigator, University Hospital of North NorwayPrincipal Investigator

Lead Sponsor

University Hospital of North NorwayOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Mentalization-based Mental Health Education in a naturalistic patient population from a psychiatric out-patient clinic in North Norway: A randomized controlled study

Detailed Description

Half of an unselecected waiting list group of patients (randomized) from a psychiatric out-patient clinic are offered a 6 hour mental health education course abour mentalizing. 1 year follow up period. Primary outcome variable is use of hospital services. Secondary outcome variables are questionnaire scores.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

256Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Patients offered mentalizing course supplemental to treatment as usual	Behavioral: Mentalizing course
Control	No Intervention	Control group - treatment as usual.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mentalizing course	Behavioral	6 hour mental health education course about mentalizing.	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital service us	Contact days (policlinic, inpatient ward and emergency team)	1year

Secondary Outcomes

Measure	Description	Time Frame
3 item wellbeing questionnaire	Each question is answered on a separate 0-9 point scale. Higher scores means better outcome.	6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all norwegian speaking patients referred to the outpatient clinic

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Poul Lundgaard, MD	Contact	+47 94785611		poul.lundgaard.bak@unn.no

Overall Officials

Name	Affiliation	Role
Poul Lundgaard, MD	University Hospital North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital North Norway	Recruiting	Harstad		9404	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided