Schema Therapy for Patients With Chronic Treatment Resistant Depression

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

Interventions

BEHAVIORAL

Schema therapy

30 sessions of schema therapy. The therapy was developed by Jeffrey Young and others and encompasses elements from cognitive behavioral, psychodynamic, and gestalt therapies, as well as attachment theory.

BEHAVIORAL

Other psychotherapy

In this arm, psychotherapy can be psychodynamic, cognitive behavioral, interpersonal or other evidence-based psychotherapies, aimed at changing cognitions, behavior, improve social relations and uncover unconstructive psychological patterns.

OTHER

Standard care package content

Standard care packages: The patient is offered prescription and monitoring of psychopharmacological treatment of up to 5 hours by a psychiatrist, when appropriate. Additionally, patients have up to 3 hours of preparatory and diagnostic sessions and up to 4 hours of meetings with the participation of next-of-kin and/or collaboration partners in other public instances. Expanded package: In one center, specialized treatment is offered for difficult-to-treat depression. Up to 9 months of psychotherapy is offered, as well as close follow-up on adjustment in medicine.

Sponsors & Collaborators

• TrygFonden, Denmark

  collaborator INDUSTRY

• Mental Health Services in the Capital Region, Denmark

  collaborator OTHER

• Region of Southern Denmark

  lead OTHER

Principal Investigators

• Stine B. Moeller, PhD · Region of Southern Denmark Psychiatry; University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2029-07-31

Completion

2029-07-31

Countries

• Denmark

Study Locations