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Mentalizing Education in a Psychiatric Out-patient Clinic

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05917535
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : June 26, 2023
Sponsor:
Information provided by (Responsible Party):
Poul Lundgaard Bak, University Hospital of North Norway

Study Description
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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

Condition or disease Intervention/treatment Phase
Mental Health Education Behavioral: Mentalizing course Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Mentalizing Education in a Psychiatric Out-patient Clinic in North Norway
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Patients offered mentalizing course supplemental to treatment as usual
 Behavioral: Mentalizing course
6 hour mental health education course about mentalizing.
No Intervention: Control
Control group - treatment as usual.


Outcome Measures
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Primary Outcome Measures :
  1. Hospital service us [ Time Frame: 1year ]
    Contact days (policlinic, inpatient ward and emergency team)


Secondary Outcome Measures :
  1. 3 item wellbeing questionnaire [ Time Frame: 6 month ]
    Each question is answered on a separate 0-9 point scale. Higher scores means better outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all norwegian speaking patients referred to the outpatient clinic

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): NCT05917535


Contacts
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Contact: Poul Lundgaard, MD +47 94785611 poul.lundgaard.bak@unn.no

Locations
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Norway
University Hospital North Norway Recruiting
Harstad, Norway, 9404
Contact: Poul Lundgaard, MD    +47 94785611    poul.lundgaard.bak@unn.no   
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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Principal Investigator: Poul Lundgaard, MD University Hospital North Norway
  Study Documents (Full-Text)

Documents provided by Poul Lundgaard Bak, University Hospital of North Norway:
Study Protocol  [PDF] March 3, 2023

More Information
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Responsible Party: Poul Lundgaard Bak, Principal Investigator, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT05917535    
Other Study ID Numbers: DPSHA-UNN Mz Study
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: June 26, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No