A Multiple Case Study of Schema Therapy for Difficult-to-treat Depression- DEPRE-ST*Case

NCT ID: NCT06655623

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2026-12-19

Brief Summary

This clinical multiple case study seeks to expand the knowledge of how schema therapy could function as an intervention for difficult-to-treat depression. The study will explore in depth the course of a 30 session treatment with schema therapy conducted over approximately one year on three individual patients at two different psychiatric treatment sites.

Together, the data from this study will inform about the feasibility of schema therapy for difficult-to-treat depression as well as form the base for recommendations in adapting schema therapy for this particular patient group.

Detailed Description

The study is part of a larger randomized controlled study, the DEPRE-ST study (clinicaltrials.gov registration: NCT05833087)(Arendt et al., 2024). The study participants will also be part of the large trial, and will be recruited for the current case study when their randomization status is being revealed; i.e., they are randomized to schema therapy.

In addition to the data collected in the DEPRE-ST trial, the patients will for each session self-report depression symptoms (before the session) and two different evaluations of the session (after the session). In addition, the patients' level of the schema therapy construct of 'Healthy Adult Mode' will be measured by self-report once monthly.

And finally, the therapist will be interviewed at the end of the treatment course about important aspects of the content and outcome of the therapy. Video recordings of each session will provide detailed information about these aspects and the interventions used in therapy.

The most important focus for the publication for this study will be to describe the trajectories of therapy for the participants, including content, effect, and subjective evaluations of therapists and participants. Also, the feasibility and adaptability of schema therapy for difficult-to-treat depression will be evaluated.

Data from outcome measurements will be presented descriptively only. Interview and video data will be compared with the outcomes measurements to reveal important events and how they might be reflected in the replies to post-session evaluation questionnaires (Session Evaluation Questionnaire and Helpful Aspects of Therapy), and in the course of the participant's self-reported depression symptoms and Healthy Adult mode.

Conditions

Depression; Major Depressive Disorder; Chronic Depression; Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Schema therapy

Schema therapy will be given in 30 sessions of 45-60 minutes over the course of 10-12 months. Concurrent treatment as part of the regular psychiatric treatment at the site may include psychotropic medication and 1-2 sessions with next-to-kin.

Group Type: EXPERIMENTAL

Schema therapy

Intervention Type: BEHAVIORAL

Schema therapy is a form of psychotherapy invented to address more complex clinical cases. It consists of elements from Cognitive Behavioral Therapy as well as psychodynamic, emotion-focused and gestalt therapies, with a distinct focus on experiential interventions. A therapy manual was developed for use in this study.

Interventions

Schema therapy

Schema therapy is a form of psychotherapy invented to address more complex clinical cases. It consists of elements from Cognitive Behavioral Therapy as well as psychodynamic, emotion-focused and gestalt therapies, with a distinct focus on experiential interventions. A therapy manual was developed for use in this study.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: collaborator

Region of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Stine Bjerrum Møller

Assistant Professor, Head of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stine B. Moeller, PhD

Role: PRINCIPAL_INVESTIGATOR

Region of Southern Denmark Psychiatry; University of Southern Denmark

Locations

Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark

Copenhagen, , Denmark

Site Status: RECRUITING

Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark

Frederiksberg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Stine B. Moeller, PhD

Role: CONTACT

stinebm@health.sdu.dk

+4551553898

Ida-Marie TP Arendt, PhD-student

Role: CONTACT

imarendt@health.sdu.dk

+4551909649

Facility Contacts

Shamaiela Anwar, Head of clinic, Special Psychologist

Role: primary

shamaiela.anwar@regionh.dk

+4538644844

Laila Ekstrøm

Role: backup

laila.ekstroem@regionh.dk

Shamaiela Anwar

Role: primary

shamaiela.anwar@regionh.dk

+4520456926

References

Arendt ITP, Gondan M, Juul S, Hastrup LH, Hjorthoj C, Bach B, Videbech P, Jorgensen MB, Moeller SB. Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST). Trials. 2024 Apr 16;25(1):266. doi: 10.1186/s13063-024-08079-9.

Reference Type: BACKGROUND

PMID: 38627837 (View on PubMed)

Lobbestael J, van Vreeswijk M, Spinhoven P, Schouten E, Arntz A. Reliability and validity of the short Schema Mode Inventory (SMI). Behav Cogn Psychother. 2010 Jul;38(4):437-58. doi: 10.1017/S1352465810000226. Epub 2010 May 21.

Reference Type: BACKGROUND

PMID: 20487590 (View on PubMed)

Reiss N, Krampen D, Christoffersen P, Bach B. Reliability and validity of the Danish version of the Schema Mode Inventory (SMI). Psychol Assess. 2016 Mar;28(3):e19-26. doi: 10.1037/pas0000154. Epub 2015 Aug 10.

Reference Type: BACKGROUND

PMID: 26375430 (View on PubMed)

Llewelyn SP, Elliott R, Shapiro DA, Hardy G, Firth-Cozens J. Client perceptions of significant events in prescriptive and exploratory periods of individual therapy. Br J Clin Psychol. 1988 May;27(2):105-14. doi: 10.1111/j.2044-8260.1988.tb00758.x.

Reference Type: BACKGROUND

PMID: 3395733 (View on PubMed)

Stiles, W. B., Reynolds, S., Hardy, G. E., Rees, A., Barkham, M., & Shapiro, D. A. (1994). Evaluation and description of psychotherapy sessions by clients using the Session Evaluation Questionnaire and the Session Impacts Scale. Journal of Counseling Psychology, 41(2), 175-185. https://doi.org/10.1037/0022-0167.41.2.175

Reference Type: BACKGROUND

Other Identifiers

S-20220033

Identifier Type: -

Identifier Source: org_study_id