Schema Therapy for Patients With Chronic Treatment Resistant Depression
Recruiting · NCT05833087 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Participants have at the time of inclusion been referred to treatment for depression as a primary diagnosis in a psychiatric clinic
- Participants should meet the diagnosis of chronic or treatment-resistant depression as follows:
- Clinical major depression as measured by the M.I.N.I. diagnostic interview: duration minimum two years OR persistent after = 2 trials of antidepressants from different classes, in an adequate dosage and time period (= 4 weeks) OR moderate treatment resistance as measured on the MSM-scale, score \> 6
- Minimum a score of 9 points on the Hamilton Rating Scale for Depression 6 (HAMD-6), corresponding to moderate to severe depression
Exclusion criteria
- Alcohol or substance abuse
- Bipolar or psychotic disorder
- Acute suicidal risk
- Mental disability (estimated IQ \< 70)
- Non-Danish speaker
- Known to be pregnant at time of inclusion
- Psychiatric comorbidity is not an exclusion criteria, until the comorbid disorder is understood to be the primary psychiatric problem and as such the patient would be treated in a different care package, e.g., for Post-Traumatic Stress Disorder
Where it is running
6 locations listed.
- Psychotherapeutic Out-patient Clinic, Psychiatric Center Ballerup, Mental Health Services, Capital Region of Denmark - Ballerup Municipality, Denmark
- Outpatient clinic for Affective Disorders, Frederiksberg, Capital Region of Denmark Psychiatry - Copenhagen, Denmark
- Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark - Copenhagen, Denmark
- Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark - Frederiksberg, Denmark
- Local Psychiatry Odense, Region of Southern Denmark Psychiatry - Odense, Denmark
- Psychiatric Unit Odense-Svendborg, Southern Region of Denmark Psychiatry - Svendborg, Denmark