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NCT Number: NCT06655623

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chronic Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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))

Treatment and study plan

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.

Primary outcomes

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

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

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

Secondary outcomes

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

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

    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."

  2. 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

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

    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.

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

    Time frame: 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.

    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'.

Other outcomes

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

    Time frame: From baseline measurements to 6 months after baseline measurements

    5-item questionnaire

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

    Time frame: From baseline measurements to 12 months after baseline measurements

    5-item questionnaire

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

    Time frame: From baseline measurements to 6 months after baseline measurements

    5-item questionnaire

  4. Psychological well-being as measured on the WHO-5 Well-Being Index at 12 months after baseline measurements

    Time frame: From baseline measurements to 12 months after baseline measurements

    5-item questionnaire

  5. Personal recovery after mental illness as measured on the INSPIRE-O Brief at 6 months after baseline measurements

    Time frame: From baseline measurements to 6 months after baseline measurements

    5-item questionnaire

  6. Personal recovery after mental illness as measured on the INSPIRE-O Brief at 12 months after baseline measurements

    Time frame: From baseline measurements to 12 months after baseline measurements

    5-item questionnaire

  7. Reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR at 6 months after baseline measurements

    Time frame: From baseline measurements to 6 months after baseline measurements

    7-item questionnaire

  8. Reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR at 12 months after baseline measurements

    Time frame: From baseline measurements to 12 months after baseline measurements

    7-item questionnaire

  9. Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 6 months after baseline assessments

    Time frame: From baseline measurements to 6 months after baseline measurements

    9-item questionnaire

  10. Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 12 months after baseline assessments

    Time frame: From baseline measurements to 12 months after baseline measurements

    9-item questionnaire

  11. Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 6 months after baseline assessments

    Time frame: From baseline measurements to 6 months after baseline measurements

    15-item questionnaire

  12. Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 12 months after baseline assessments

    Time frame: From baseline measurements to 12 months after baseline measurements

    15-item questionnaire

  13. Negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 6 months after randomization

    Time frame: From baseline measurements to 12 months after baseline measurements

    20-item questionnaire

  14. Negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 12 months after randomization

    Time frame: From baseline measurements to 12 months after baseline measurements

    20-item questionnaire

  15. Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at 6 months after baseline assessments

    Time frame: From baseline measurements to 6 months after baseline measurements

    Questionnaire with qualitative definition of patient defined problems and change on 6-point Likert scale

  16. Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at 12 months after baseline assessments

    Time frame: From baseline measurements to 12 months after baseline measurements

    Questionnaire with qualitative definition of patient defined problems and change on 6-point Likert scale

  17. anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 6 months after baseline assessments

    Time frame: From baseline measurements to 6 months after baseline measurements

    5-item questionnaire - only anxiety items are used

  18. anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 12 months after baseline assessments

    Time frame: From baseline measurements to 12 months after baseline measurements

    5-item questionnaire - only anxiety items are used

  19. Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 6 months after baseline assessments

    Time frame: From baseline measurements to 6 months after baseline measurements

    5-item questionnaire

  20. Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 12 months after baseline assessments

    Time frame: From baseline measurements to 12 months after baseline measurements

    5-item questionnaire

  21. 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

    Time frame: At baseline only

    11-item questionnaire - items about pessimistic expectations only

  22. Schema modes as mediators of treatment effect after 6 months, as measured on the Schema Mode Inventory (SMI)

    Time frame: From baseline measurements to 6 months after baseline measurements

    37-item questionnaire - a subset of the original 118-item measure, encompassing Vulnerable Child, Healthy Adult, Demanding Critic and Punitive Critic modes

  23. Schema modes as mediators of treatment effect after 12 months, as measured on the Schema Mode Inventory (SMI)

    Time frame: From baseline measurements to 12 months after baseline measurements

    118-item questionnaire

  24. Early maladaptive schemas as measured after 6 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)

    Time frame: From baseline measurements to 6 months after baseline measurements

    25-item questionnaire - a subset of the original 90-item measure, encompassing the schemas Emotional Deprivation, Abandonment, Mistrust/Abuse, Social Isolation, and Defectiveness

  25. Early maladaptive schemas as measured after 12 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)

    Time frame: From baseline measurements to 12 months after baseline measurements

    90-item questionnaire

  26. Treatments for depression in earlier and current depressive episode

    Time frame: Collected at baseline only

    Psychotherapeutic, psychopharmacological treatment, Electroconvulsive therapy and psychiatric hospitalization, both collected from participant's given information and electronic journal records.

  27. Childhood adversity, as measured on the Childhood Trauma Questionnaire (CTQ)

    Time frame: Collected at baseline only

    28-item questionnaire

Sponsors and collaborators

Lead sponsor

Region of Southern Denmark

Other

Collaborators

  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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