Using schema therapy to treat chronic treatment resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to evaluate the effectiveness of schema therapy, a specific form of psychotherapy, for individuals suffering from chronic treatment resistant depression. Participants will be divided into two groups: one receiving schema therapy and the other receiving standard psychotherapeutic treatment. The study will assess depression outcomes at multiple time points, including 6, 12, and 24 months, while also exploring secondary outcomes related to functioning and personal recovery. Additionally, the research seeks to refine the understanding of chronic treatment resistant depression and its characteristics.

Why it matters

Who can join: the full rules

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:

  1. 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
  2. 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's running

• Psychotherapeutic Out-patient Clinic, Psychiatric Center Ballerup, Mental Health Services, Capital Region of Denmark
  Ballerup Municipality, Denmark Recruiting
• Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark
  Copenhagen, Denmark Recruiting
• Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark
  Frederiksberg, Denmark Recruiting
• Local Psychiatry Odense, Region of Southern Denmark Psychiatry
  Odense, Denmark Recruiting
• Outpatient clinic for Affective Disorders, Frederiksberg, Capital Region of Denmark Psychiatry
  Copenhagen, Denmark Not yet recruiting
• Psychiatric Unit Odense-Svendborg, Southern Region of Denmark Psychiatry
  Svendborg, Denmark Not yet recruiting

Study contacts

• Principal investigator: Stine B. Moeller, PhD — Region of Southern Denmark Psychiatry; University of Southern Denmark
• Study coordinator: Ida-Marie T. P. Arendt
• Email: imarendt@health.sdu.dk
• Phone: +4551909649

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.