Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05833087

Schema Therapy for Patients With Chronic Treatment Resistant Depression

Led by Region of Southern Denmark · Updated on 2025-09-23

129

Participants Needed

6

Research Sites

328 weeks

Total Duration

On this page

Sponsors

R

Region of Southern Denmark

Lead Sponsor

T

TrygFonden, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical study is to test a particular form of psychotherapy, called schema therapy, for people with difficult-to-treat depression (when depression is very lengthy or difficult to cure with antidepressive medication). Researchers will compare the group of participants receiving schema therapy to a group receiving standard psychotherapeutic treatment to see if schema therapy is more effective on depression symptoms and other important issues for the participant. The main question the study aims to answer is: \- Can schema therapy be a more effective treatment for difficult-to-treat depression than other forms of psychotherapy offered in psychiatry today? People who have difficult-to-treat depression are a special group of patients who are more strained in a wide range of areas of life than other people with depression. They also more often have childhood trauma, as well as simultaneous personality disorder or personality traits that brings challenges in everyday life. Currently we can not offer a sufficiently effective psychiatric treatment for this group of people. Schema therapy was developed to help patients who do not have sufficient effect of the usual psychotherapeutic treatments. It also addresses personality disorders or problematic traits and childhood trauma directly in the therapy. The project will include 129 participants in total, of which half will receive schema therapy. Treatment is provided at six psychiatric centers in both the Southern and the Capital Regions of Denmark. Participants receiving schema therapy will be given 30 sessions of weekly therapy, as well as the opportunity for the rest of the standard care package in the Danish secondary mental health system, that is, treatment with psychopharmacological medicine and meetings with next-to-kin and other parts of the participant's support system. Participants receiving the standard treatment will receive about 6-20 sessions of individual or group therapy with a range of other psychotherapies that are not schema therapy, as well as the other parts of the standard care package as listed above. If schema therapy proves to be more effective for treatment of difficult-to-treat depression than the treatment offered today, it may give rise to more extended use of schema therapy in and outside psychiatry. This means that the toolbox for the treatment of difficult-to-treat depression is expanded with a new specialized and effective psychotherapeutic tool.

CONDITIONS

Official Title

Schema Therapy for Patients With Chronic Treatment Resistant Depression

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants have been referred to treatment for depression as a primary diagnosis in a psychiatric clinic
  • Participants meet the diagnosis of chronic or treatment-resistant depression defined as clinical major depression lasting at least two years or persistent after at least two adequate antidepressant trials, or moderate treatment resistance with a score greater than 6 on the Maudsley Staging Model
  • Minimum score of 9 points on the Hamilton Rating Scale for Depression 6 (HAMD-6), indicating moderate to severe depression
  • Age between 18 and 65 years
  • Ability to speak Danish
Not Eligible

You will not qualify if you...

  • Alcohol or substance abuse
  • Bipolar or psychotic disorder
  • Acute suicidal risk
  • Mental disability with estimated IQ less than 70
  • Not able to speak Danish
  • Known pregnancy at time of inclusion
  • Psychiatric comorbidity is allowed unless it is the primary psychiatric problem requiring a different care package

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Trial Site Locations

Total: 6 locations

1

Psychotherapeutic Out-patient Clinic, Psychiatric Center Ballerup, Mental Health Services, Capital Region of Denmark

Ballerup Municipality, Denmark, 2750

Actively Recruiting

2

Outpatient clinic for Affective Disorders, Frederiksberg, Capital Region of Denmark Psychiatry

Copenhagen, Denmark, 2000

Not Yet Recruiting

3

Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark

Copenhagen, Denmark, 2200

Actively Recruiting

4

Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark

Frederiksberg, Denmark

Actively Recruiting

5

Local Psychiatry Odense, Region of Southern Denmark Psychiatry

Odense, Denmark

Actively Recruiting

6

Psychiatric Unit Odense-Svendborg, Southern Region of Denmark Psychiatry

Svendborg, Denmark, 5700

Not Yet Recruiting

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Research Team

I

Ida-Marie T. P. Arendt

CONTACT

S

Stine B. Møller, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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