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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Major Depressive Disorder; Treatment Resistant Depression; Chronic Depression
• Intervention / Treatment: Behavioral: Schema therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark
  • Frederiksberg, Denmark
    • Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

(The inclusion and exclusion criteria follow that of the mother study (clinicaltrial.gov ID NCT05833087))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's experience of helpful events in therapy, as measured by the Helpful Aspects of Therapy (HAT)	The HAT was developed as a mixed qualitative and quantitative measure for describing what events in therapy were helpful or hindering for a good therapy outcome (Llewyn et al., 1988). This study will only include the first two items, which provide two blank text boxes for free writing of replies. The questions are: "Of the events which occurred in this session, which one do you feel was the most helpful or important for you personally? (By "event" we mean something that happened in the session. It might be something you said or did, or something your therapist said or did.)"; "Please describe what made this event helpful/important and what you got out of it."	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	The SEQ quantitively evaluates the psychotherapy session (9 items) and the patient's mood after the session (8 items)(the original SEQ was 21 items, but four items were removed for this study due to redundancy (Stiles et al., 1994)). Each item is scored on a bipolar, 7-point Likert scale, ranging from 1-7 and containing different, opposing aspects, e.g., 'bad-good', 'difficult-easy'. The patient is instructed to circle the appropriate number according to how they feel about the session and in themselves.	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	The SMI was invented to measure the psychological construct of schema modes, which are emotional activations to the activation of inherent early maladaptive schemas (cognitive constructs mostly formed in childhood)(Lobbestael et al., 2010)Reiss et al., 2016). This study will only measure the Healthy Adult mode, as the strengthening of this mode is usually an important treatment focus in schema therapy. The Healthy Adult mode is measured in 10 items, containing different aspects of Healthy Adult, measured on a 6 point Likert scale ranging from 'Never or almost never' to 'Always'.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction for treatment effect of negative expectancies for change in depression symptoms as measured on the Depression Change Expectancy Scale-pessimistic (DCES-P) items at baseline assessments	11-item questionnaire - items about pessimistic expectations only	At baseline only
Subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 6 months after baseline measurements	5-item questionnaire	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	5-item questionnaire	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	5-item questionnaire	From baseline measurements to 6 months after baseline measurements
Psychological well-being as measured on the WHO-5 Well-Being Index at 12 months after baseline measurements	5-item questionnaire	From baseline measurements to 12 months after baseline measurements
Personal recovery after mental illness as measured on the INSPIRE-O Brief at 6 months after baseline measurements	5-item questionnaire	From baseline measurements to 6 months after baseline measurements
Personal recovery after mental illness as measured on the INSPIRE-O Brief at 12 months after baseline measurements	5-item questionnaire	From baseline measurements to 12 months after baseline measurements
Reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR at 6 months after baseline measurements	7-item questionnaire	From baseline measurements to 6 months after baseline measurements
Reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR at 12 months after baseline measurements	7-item questionnaire	From baseline measurements to 12 months after baseline measurements
Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 6 months after baseline assessments	9-item questionnaire	From baseline measurements to 6 months after baseline measurements
Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 12 months after baseline assessments	9-item questionnaire	From baseline measurements to 12 months after baseline measurements
Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 6 months after baseline assessments	15-item questionnaire	From baseline measurements to 6 months after baseline measurements
Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 12 months after baseline assessments	15-item questionnaire	From baseline measurements to 12 months after baseline measurements
Negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 6 months after randomization	20-item questionnaire	From baseline measurements to 12 months after baseline measurements
Negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 12 months after randomization	20-item questionnaire	From baseline measurements to 12 months after baseline measurements
Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at 6 months after baseline assessments	Questionnaire with qualitative definition of patient defined problems and change on 6-point Likert scale	From baseline measurements to 6 months after baseline measurements
Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at 12 months after baseline assessments	Questionnaire with qualitative definition of patient defined problems and change on 6-point Likert scale	From baseline measurements to 12 months after baseline measurements
anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 6 months after baseline assessments	5-item questionnaire - only anxiety items are used	From baseline measurements to 6 months after baseline measurements
anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 12 months after baseline assessments	5-item questionnaire - only anxiety items are used	From baseline measurements to 12 months after baseline measurements
Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 6 months after baseline assessments	5-item questionnaire	From baseline measurements to 6 months after baseline measurements
Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 12 months after baseline assessments	5-item questionnaire	From baseline measurements to 12 months after baseline measurements
Schema modes as mediators of treatment effect after 6 months, as measured on the Schema Mode Inventory (SMI)	37-item questionnaire - a subset of the original 118-item measure, encompassing Vulnerable Child, Healthy Adult, Demanding Critic and Punitive Critic modes	From baseline measurements to 6 months after baseline measurements
Schema modes as mediators of treatment effect after 12 months, as measured on the Schema Mode Inventory (SMI)	118-item questionnaire	From baseline measurements to 12 months after baseline measurements
Early maladaptive schemas as measured after 6 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)	25-item questionnaire - a subset of the original 90-item measure, encompassing the schemas Emotional Deprivation, Abandonment, Mistrust/Abuse, Social Isolation, and Defectiveness	From baseline measurements to 6 months after baseline measurements
Early maladaptive schemas as measured after 12 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)	90-item questionnaire	From baseline measurements to 12 months after baseline measurements
Treatments for depression in earlier and current depressive episode	Psychotherapeutic, psychopharmacological treatment, Electroconvulsive therapy and psychiatric hospitalization, both collected from participant's given information and electronic journal records.	Collected at baseline only
Childhood adversity, as measured on the Childhood Trauma Questionnaire (CTQ)	28-item questionnaire	Collected at baseline only

Collaborators and Investigators

• Sponsor: Region of Southern Denmark
• Collaborators: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
• Investigators: Principal Investigator: Stine B. Moeller, PhD, Region of Southern Denmark Psychiatry; University of Southern Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Actual): February 20, 2026
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: psychotherapy; schema therapy; difficult-to-treat depression
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Psychotherapy; Behavioral Disciplines and Activities; Schema Therapy
• Other Study ID Numbers: S-20220033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared upon reasonable request by contacting the central contact persons of the study.
• IPD Sharing 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).
• IPD Sharing Access Criteria: Researchers or other professionals will gain access to all IPD upon request via a secure link/attachment provided by the study researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No