Clinical trial NCT06655623: A Multiple Case Study of Schema Therapy for Difficult-to-treat Depression- DEPRE-ST*Case
Official title: A Multiple Case Study of Schema Therapy for Difficult-to-treat Depression - DEPRE-ST*Case
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Major Depressive Disorder
Chronic Depression
Treatment Resistant Depression
Keywords: schema therapy
psychotherapy
difficult-to-treat depression
Lead sponsor: Region of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Mental Health Services in the Capital Region, Denmark
First posted: 2024-10-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

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))

Primary outcomes:
measure: Depression symptoms, as measured with the Hamilton Depression Rating Scale 6 items (HAMD-6), self-report
timeFrame: Approximately once a week during the course of therapy (30-52 weeks in total), before each therapy session (30 sessions in total)
Secondary outcomes:
measure: Patient's experience of helpful events in therapy, as measured by the Helpful Aspects of Therapy (HAT)
timeFrame: Administered from the initiation of therapy, after every session (approximately once a week for 30-52 weeks, 30 sessions in total)
measure: 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
timeFrame: Administered from the initiation of therapy, after every therapy session (approximately once a week, 30 sessions)
measure: Healthy Adult schema mode, as measured on the Schema Schema Mode Inventory (SMI) - Healthy Adult subscale
timeFrame: 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:
measure: Subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 6 months after baseline measurements
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Subjective functional impairment as measured on the Work and Social Adjustment Scale (WSAS) at 12 months after baseline measurements
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Psychological well-being as measured on the WHO-5 Well-Being Index at 6 months after baseline measurements
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Psychological well-being as measured on the WHO-5 Well-Being Index at 12 months after baseline measurements
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Personal recovery after mental illness as measured on the INSPIRE-O Brief at 6 months after baseline measurements
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Personal recovery after mental illness as measured on the INSPIRE-O Brief at 12 months after baseline measurements
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR at 6 months after baseline measurements
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Reactions to anger as measured on the Dimensions of Anger Reactions - Revised (DAR at 12 months after baseline measurements
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 6 months after baseline assessments
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Changes in anger processing as measured on the Metacognitive Anger Processing scale Short Version (MAP) at 12 months after baseline assessments
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 6 months after baseline assessments
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Changes in repetitive negative thinking as measured on the Perseverative Thinking Questionnaire (PTQ) at 12 months after baseline assessments
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 6 months after randomization
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Negative effects of treatment as measured on the Negative Effects Questionnaire (NEQ) at 12 months after randomization
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at 6 months after baseline assessments
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Changes in 1-2 patient defined problems as measured on the Psychological Outcome Profiles (PSYCHLOPS) at 12 months after baseline assessments
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 6 months after baseline assessments
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: anxiety symptoms as measured on the Symptom Checklist-10 (SCL-10) at 12 months after baseline assessments
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 6 months after baseline assessments
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Changes in health-related quality of life as measured on the Euro-Qol-5D (EQ-5D) at 12 months after baseline assessments
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: 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
timeFrame: At baseline only
measure: Schema modes as mediators of treatment effect after 6 months, as measured on the Schema Mode Inventory (SMI)
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Schema modes as mediators of treatment effect after 12 months, as measured on the Schema Mode Inventory (SMI)
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Early maladaptive schemas as measured after 6 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)
timeFrame: From baseline measurements to 6 months after baseline measurements
measure: Early maladaptive schemas as measured after 12 months on the Young Schema Questionnaire 3 Short Form (YSQ-S3)
timeFrame: From baseline measurements to 12 months after baseline measurements
measure: Treatments for depression in earlier and current depressive episode
timeFrame: Collected at baseline only
measure: Childhood adversity, as measured on the Childhood Trauma Questionnaire (CTQ)
timeFrame: Collected at baseline only
Locations:
Study officials:
affiliation: Region of Southern Denmark Psychiatry; University of Southern Denmark
name: Stine B. Moeller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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