Using schema therapy to treat chronic treatment resistant depression
A Randomized Controlled Trial of Schema Therapy for Patients With Chronic Treatment Resistant Depression
NA · Region of Southern Denmark · NCT05833087
This study is testing if schema therapy can help people with chronic depression that hasn't improved with other treatments feel better compared to those getting standard therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 129 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Region of Southern Denmark (other) |
| Locations | 6 sites (Ballerup Municipality and 5 other locations) |
| Trial ID | NCT05833087 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with chronic or treatment-resistant depression who have not responded adequately to previous antidepressant treatments.
Not a fit: Patients with acute suicidal risk, bipolar disorder, or psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with chronic treatment resistant depression.
How similar studies have performed: While schema therapy has shown promise in treating various psychological conditions, this specific application for chronic treatment resistant depression is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ballerup Municipality and 5 other locations
- Psychotherapeutic Out-patient Clinic, Psychiatric Center Ballerup, Mental Health Services, Capital Region of Denmark — Ballerup Municipality, Denmark (RECRUITING)
- Outpatient clinic for Affective Disorders, Frederiksberg, Capital Region of Denmark Psychiatry — Copenhagen, Denmark (NOT_YET_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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Treatment Resistant Depression, Chronic Depression, treatment resistant depression, schema therapy, psychotherapy, difficult-to-treat depression, chronic depression, clinical trial