NCT06315114 A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders
| NCT ID | NCT06315114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
| Condition | Mental Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2024-03-11 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service.
Eligibility Criteria
Inclusion Criteria exclusive to the Outpatient Clinic * Age \>18 years * Seeking treatment for one of the following non-psychotic disorders according to ICD-10: obsessive-compulsive disorder and anxiety disorders (F40-42), posttraumatic stress disorder (DF43), personality disorders (F60-61), or one of the previous disorders and a drug-or alcohol related disorder (F10-19) (i.e. 'dual diagnosis disorder') Inclusion Criteria exclusive to the trial: * Parent of at least one child aged 0-17 years of age at baseline * Fluent i.e., sufficient Danish language skills * Parent is living with child or is in regular contact (min. 5 days monthly) * Written informed consent Exclusion Criteria exclusive to the Outpatient Clinic: * Possibility of a learning disability (IQ\<75) * A diagnosis of schizotypal personality disorder or antisocial personality disorder * Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere * Concurrent psychotherapeutic treatment outside the clinic Exclusion Criteria exclusive to the trial: * Acute suicidal risk or state of crises * Lack of informed consent * Acute child endangerment * Participation in another parenting focused intervention simultaniously
Contact & Investigator
Sebastian Simonsen, Doctor
STUDY DIRECTOR
Mental Health Service, Capital Region, Denmark
Frequently Asked Questions
Who can join the NCT06315114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Mental Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06315114 currently recruiting?
Yes, NCT06315114 is actively recruiting participants. Contact the research team at emilie.hestbaek.jacobsen@regionh.dk for enrollment information.
Where is the NCT06315114 trial being conducted?
This trial is being conducted at Gentofte Municipality, Denmark, Gentofte Municipality, Denmark.
Who is sponsoring the NCT06315114 clinical trial?
NCT06315114 is sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital. The principal investigator is Sebastian Simonsen, Doctor at Mental Health Service, Capital Region, Denmark. The trial plans to enroll 170 participants.