DepressionNCT06655623
A Multiple Case Study of Schema Therapy for Difficult-to-treat Depression- DEPRE-ST*Case
A study testing Schema therapy in people with Depression and Major Depressive Disorder, run by Region of Southern Denmark at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Major Depressive Disorder, Chronic Depression
- What is being tested?
- Schema therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesDenmark
- Study dates
- 6 Nov 2024to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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))
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Psychotherapeutic Out-patient Clinic, Psychiatric Center Copenhagen/Nannasgade, Mental Health Services, Capital Region of Denmark
Copenhagen, 2200
Psychotherapeutic Clinic Frederiksberg, Psychiatric Center Copenhagen, Mental Health Services, Capital Region of Denmark
Frederiksberg
About this study
Official title: 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.
Read the 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.
- Being tested
- Schema therapy
- Keywords
- schema therapy, psychotherapy, difficult-to-treat depression
- Medical subject headings
- Depression, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schema therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Schema therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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."
Measured: 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.
Measured: 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'.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 Nov 2024
- Primary completion20 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Principal investigator, Stine Bjerrum Møller, Region of Southern Denmark
- Investigators
- Stine B. Moeller, PhD, Principal investigator, Region of Southern Denmark Psychiatry; University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655623
- Sponsor's protocol ID
- S-20220033
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request by contacting the central contact persons of the study.
Publications
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.
PubMed 38627837Lobbestael 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.
PubMed 20487590Reiss 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.
PubMed 26375430Llewelyn 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.
PubMed 3395733Stiles, 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 at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Case Study of Schema Therapy for Difficult-to-treat Depression - DEPRE-ST*Case
- ClinicalTrials.gov ID
- NCT06655623
- Acronym / sponsor ID
- S-20220033
- Keywords
- schema therapy, psychotherapy, difficult-to-treat depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Schema therapy | Experimental | Behavioral: Schema therapySchema 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (8 listed)
- Alcohol or substance abuse
- Bipolar or psychotic disorder
- Acute suicidal risk
- Mental disability (estimated IQ < 70)
- Non-Danish speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schema therapySchema 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. | Behavioural | Schema therapy |
Primary outcome
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.
3 secondary outcomes
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)
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 38627837Arendt 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.
- Background: PubMed 20487590Lobbestael 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.
- Background: PubMed 26375430Reiss 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.
- Background: PubMed 3395733Llewelyn 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.
- BackgroundStiles, 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
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request by contacting the central contact persons of the study.
Related trials for Depression
Not yet recruiting
The Lucida Project
Depression Disorder
Recruiting
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Depressive Disorder, Treatment-Resistant, Memory Deficits
RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine B. Moeller, PhD principal investigator
Region of Southern Denmark Psychiatry; University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schema therapy in people with Depression and Major Depressive Disorder, run by Region of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655623, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.