Brief Summary

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

• Treatment Resistant Depression
• Chronic Depression

Intervention / Treatment

• Behavioral: Schema therapy
• Behavioral: Other psychotherapy
• Other: Standard care package content

Primary Outcome Measures

• Change from baseline in depression symptoms on the clinician-rated Hamilton-6 Rating Scale for Depression at 12 months after baseline measurements (From baseline measurements to end of treatment (of schema therapy) at 12 months)
  6-item clinician rated instrument

Countries

Denmark

Locations and Investigators

• Psychotherapeutic Out-patient Clinic, Psychiatric Center Ballerup, Mental Health Services, Capital Region of Denmark, Ballerup Municipality, Denmark (Recruiting)
  • Kirsten Stengaard Møller
  • Clas W. Christensen
• Outpatient clinic for Affective Disorders, Frederiksberg, Capital Region of Denmark Psychiatry, Copenhagen, Denmark (Not yet recruiting)
  • Line Hansen, Head Physician, Medical Doctor
  • Kirstine Wedell Winther, Head Nurse
• Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark (Recruiting)
  • Nicole G Rosenberg
  • Laila Ekstrøm
• Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark, Frederiksberg, Denmark (Recruiting)
  • Shamaiela Anwar
  • Sebastian Swane
• Local Psychiatry Odense, Region of Southern Denmark Psychiatry, Odense, Denmark (Recruiting)
  • Susie Andersen
• Psychiatric Unit Odense-Svendborg, Southern Region of Denmark Psychiatry, Svendborg, Denmark (Not yet recruiting)
  • Sune Bo, PhD, special psychologist

Study Officials

• Stine B. Moeller, PhD (Principal Investigator) — Region of Southern Denmark Psychiatry; University of Southern Denmark