Schema Therapy for Patients With Chronic Treatment Resistant Depression
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.
detailed description
Aims of study:
The central aim of this study is to investigate whether Schema Therapy (ST) of longer duration (up to 30 sessions) outperforms the current treatment as usual (TAU) for patients with chronic and treatment resistant depression (CTRD) on depression outcomes at 12 months after baseline measurements, as well as at 6 and 24 months time points after baseline. It is hypothesized that the treatment effect in ST is mediated by changes in the psychological phenomenons called modes, namely Healthy Adult Mode and Vulnerable Child Mode, and that treatment effect is moderated by childhood adversity.
A second aim is to expand the understanding of what constitutes a successful therapy by investigating relevant secondary outcomes at the same time points. When dealing with chronic and/or treatment resistant illnesses, other success criteria such as level of functioning, personal recovery, or a completely different, patient-generated outcome, might be more obtainable than improvements in illness symptoms alone.
Also, it will be investigated whether schema therapy is more advantageous from a health economic aspect, both in terms of quality of life for the patient and from an economical societal perspective.
The final aim for the study is to investigate and define the population of patients with CTRD. It will be attempted to refine the Maudsley Staging Model for CTRD by including (failed) psychotherapy trials. As a part of this, it will be investigated whether patients with Treatment Resistant Depression (TRD) and Chronic Depression (CD), respectively, can be adequately understood as exhibiting similar characteristics in symptoms and response to treatments.
Background for study:
CTRD-patients seem to differ substantially from non-CTRD patients in numerous respects: factors such as adverse events in childhood, higher prevalence of comorbid personality disorders as well as inhibiting personality features, interpersonal behavior and cognitive styles.
With this knowledge, ST may be a particularly promising treatment for CTRD, as it targets both childhood adversity and particular inhibiting personality features. Going to the 'root of problems', ST can potentially have a more enduring effect on the presenting symptoms. Also, CTRD responds differently to psychotherapy than non-CTRD with smaller effects and with fewer 'sudden gains' compared to non-chronic depression. Longer duration of treatment also seems to be necessary; a meta-analysis estimated a minimum of 18 sessions necessary to produce convincing results. It is thus likely that a longer duration of ST therapy, as opposed to the shorter TAU, will still be cost-effective due to greater and/or longer-lasting effects.
official title
A Randomized Controlled Trial of Schema Therapy for Patients With Chronic Treatment Resistant Depression