- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917535
Mentalizing Education in a Psychiatric Out-patient Clinic
June 23, 2023 updated by: Poul Lundgaard Bak, University Hospital of North Norway
Mentalizing Education in a Psychiatric Out-patient Clinic in North Norway
Mentalization-based Mental Health Education in a naturalistic patient population from a psychiatric out-patient clinic in North Norway: A randomized controlled study
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
256
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Poul Lundgaard, MD
- Phone Number: +47 94785611
- Email: poul.lundgaard.bak@unn.no
Study Locations
-
-
-
Harstad, Norway, 9404
- Recruiting
- University Hospital North Norway
-
Contact:
- Poul Lundgaard, MD
- Phone Number: +47 94785611
- Email: poul.lundgaard.bak@unn.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- all norwegian speaking patients referred to the outpatient clinic
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Patients offered mentalizing course supplemental to treatment as usual
|
6 hour mental health education course about mentalizing.
|
No Intervention: Control
Control group - treatment as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital service us
Time Frame: 1year
|
Contact days (policlinic, inpatient ward and emergency team)
|
1year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3 item wellbeing questionnaire
Time Frame: 6 month
|
Each question is answered on a separate 0-9 point scale.
Higher scores means better outcome.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Poul Lundgaard, MD, University Hospital North Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
June 23, 2023
First Posted (Actual)
June 26, 2023
Study Record Updates
Last Update Posted (Actual)
June 26, 2023
Last Update Submitted That Met QC Criteria
June 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- DPSHA-UNN Mz Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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