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

NCT06655623 | Completed

• 1 other identifier: S-20220033
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

schema therapy; psychotherapy; difficult-to-treat depression

Outcome Measures

Primary Outcomes (1)

• Depression symptoms, as measured with the Hamilton Depression Rating Scale 6 items (HAMD-6), self-report

  This scale was derived from the Hamilton Depression Rating Scale 17 items and focuses on the six core symptoms of depression.

  Approximately once a week during the course of therapy (30-52 weeks in total), before each therapy session (30 sessions in total)

Secondary Outcomes (3)

• Patient's experience of helpful events in therapy, as measured by the Helpful Aspects of Therapy (HAT)

  Administered from the initiation of therapy, after every session (approximately once a week for 30-52 weeks, 30 sessions in total)

• Patient's experiences of important aspects of the therapy session and the patient's mood in relation to the session, as measured by the Session Evaluation Questionnaire

  Administered from the initiation of therapy, after every therapy session (approximately once a week, 30 sessions)

• Healthy Adult schema mode, as measured on the Schema Schema Mode Inventory (SMI) - Healthy Adult subscale

  Administered from the initiation of therapy - once a month, i.e. 10-12 times in total, at the end of a session of schema therapy.

Other Outcomes (27)

• Subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 6 months after baseline measurements

  From baseline measurements to 6 months after baseline measurements

• Subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 12 months after baseline measurements

  From baseline measurements to 12 months after baseline measurements

• Psychological well-being as measured on the WHO-5 Well-Being Index at 6 months after baseline measurements

  From baseline measurements to 6 months after baseline measurements

Study Arms (1)

Schema therapy

EXPERIMENTAL

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.

Behavioral: Schema therapy

Interventions

Schema therapy 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.

Schema therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants should meet the diagnosis of chronic or treatment-resistant depression as follows:
• 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
• Minimum a score of 9 points on the Hamilton Rating Scale for Depression 6 (HAMD-6), corresponding to moderate to severe depression

You may not qualify if:

• Alcohol or substance abuse
• Bipolar or psychotic disorder
• Acute suicidal risk
• Mental disability (estimated IQ \< 70)
• Non-Danish speaker

Sponsors & Collaborators

• Region of Southern Denmark: lead
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (2)

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

Copenhagen, 2200, Denmark

Location

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

Frederiksberg, Denmark

Location

Related Publications (5)

• 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.

  PMID: 38627837 BACKGROUND

• 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.

  PMID: 20487590 BACKGROUND

• 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.

  PMID: 26375430 BACKGROUND

• 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.

  PMID: 3395733 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Schema Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stine B. Moeller, PhD

  Region of Southern Denmark Psychiatry; University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant and investigator are both blinded to condition at the initial baseline measurements, since randomization and assignment to treatment are only made after the baseline measurements have taken place.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Head of Research

Model Details: This study is a multiple case study of three patients with difficult-to-treat depression. The patients are also part of a larger, randomized controlled trial with two treatment arms (which also includes a Treatment As Usual arm), in which they have been assigned to the schema therapy arm.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: November 6, 2024
• Primary Completion: February 20, 2026
• Study Completion: February 26, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available from the end of collection of data (approximately February 2026) until few years after the termination of data collection (approximately February 2031).
• Access Criteria: Researchers or other professionals will gain access to all IPD upon request via a secure link/attachment provided by the study researchers.

Locations

DK (2)