An interventional study of SELF-7 and F-ACT in Schizophrenia Spectrum Disorders (SSD), sponsored by Psychiatric Research Unit, Region Zealand, Denmark. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Psychiatric Research Unit, Region Zealand, Denmark · Not applicable, Interventional, and Treatment
Among 79 studies in Schizophrenia with a site in Denmark — 10 open to participants now, 12 under way, none of them phase 3. Schizophrenia · Denmark.
Among the 79 studies in Schizophrenia with a site in Denmark, this one is the 57th largest by planned enrollment of the 67 interventional ones that give a count, is the only one that started in 2026, is one of 38 with no phase, reaches primary completion later than 10 of the 11 other live ones, and was the 79th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
Browse Schizophrenia studies →10 of the 79 studies in Schizophrenia with a site in Denmark are open now. Recruiting first, the newest first:
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Sites in Denmark
Nikolai Albert · Sites in Denmark
Anders Fink-Jensen, MD, DMSci · Sites in Denmark
Ole Köhler-Forsberg · Sites in Denmark
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Sites in Denmark
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 40 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Median enrollment 108 across the 67 interventional studies, 203 across the 11 observational. Of the 61 that completed or were terminated, 5 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 79 have an industry lead sponsor. The 10 most frequent:
Psychiatric Research Unit, Region Zealand, Denmark is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Psychiatric Research Unit, Region Zealand, Denmark has 2 studies filed under Schizophrenia — fewer than ten, so there is no comparison to draw.
4 of the studies in Schizophrenia with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07716969Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalTOPUS - Testing an Implemented Intervention to Reduce Duration of Untreated Psychosis | 2026-12-31 |
| NCT06431009University of AarhusThe Danish Region Midt Schizophrenia Cohort | 2026-12-31 |
| NCT07082777University of AarhusRecovery in Telling Life Stories | 2027-04-01 |
| NCT07404085Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalEpigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations | 2027-07-01 |
Among the 79 studies in Schizophrenia with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary goal of the VITALIZE study is to evaluate the feasibility of SELF-7, a novel phenomenologically informed psychotherapy for self-disorders, as an add-on to standard psychiatric outpatient treatment - Flexible Assertive Community Treatment (F-ACT) - in adults with schizophrenia spectrum disorders. The main question is whether SELF-7 is feasible and acceptable in routine psychiatric outpatient care (F-ACT teams). A secondary objective of the study is to explore whether SELF-7 may reduce psychological distress related to self-disorders and improve personal recovery, well-being, functioning, perceived stress, suicidal ideation, symptom severity, insight, and self-disorders. Researchers will compare SELF-7 plus F-ACT with F-ACT alone. Participants will be randomized to one of the two groups, complete clinical interviews and questionnaires at baseline, 16 weeks, and 26 weeks, and, if allocated to SELF-7, receive 12 individual psychotherapy sessions in addition to standard care (F-ACT).
Schizophrenia spectrum disorders (SSD) are associated with self-disorders, a group of non-psychotic, trait-like phenomena considered close to the psychopathological core of SSD. Systematic reviews and meta-analyses have consistently demonstrated high levels of self-disorders in individuals with SSD. Although cognitive behavioral therapy (CBT) is recommended as an adjunctive psychological treatment for schizophrenia, meta-analytic evidence suggests that its efficacy is limited. It has been proposed that this may reflect a mismatch between psychotherapeutic approach and the psychopathological core of SSD. Consequently, there is a need to develop and evaluate psychotherapeutic interventions that are more closely tailored to these core features.
SELF-7 is a novel, manualized, phenomenologically informed psychotherapeutic intervention with integrated psychoeducational components targeting self-disorders in SSD. The intervention was developed from the Seven Step Phenomenological Psychotherapy for Self-Disorder (SSPP-SD), drawing on extensive clinical experience in Norway and further refined through pilot projects conducted in Norway and Denmark. SELF-7 is delivered according to a manual comprising seven thematic modules and is designed to support patients' awareness, understanding, and coping with difficulties related to self-disorders, while strengthening adaptive coping, facilitating change, and supporting coherence in self-experience.
The VITALIZE study is a two-arm, parallel, randomized controlled feasibility trial investigating SELF-7 as an add-on to standard outpatient treatment delivered through Flexible Assertive Community Treatment (F-ACT) teams. The primary objective is to examine the feasibility of SELF-7 for patients with SSD in an outpatient setting. The secondary objective is to explore preliminary clinical effects of the intervention.
Forty adult patients with schizophrenia (ICD-10 F20.x) or schizotypal disorder (ICD-10 F21) who have been discharged from OPUS, an early intervention outpatient programme, within the previous five years and are currently receiving treatment in an F-ACT team will be randomized in a 1:1 ratio to either SELF-7 plus F-ACT or F-ACT alone.
Participants allocated to SELF-7 will receive 12 sessions of individual psychotherapy preceded by an Examination of Anomalous Self-Experience (EASE) interview. Therapy will be delivered by trained research therapists while participants continue to receive standard F-ACT throughout the intervention period. Participants allocated to the control group will continue receiving F-ACT alone.
As the primary aim of the study is to assess feasibility, feasibility outcomes constitute the primary trial outcomes. Feasibility will be evaluated across five predefined domains: acceptability, adherence, patient satisfaction, patient and therapist evaluations, and adverse events. These outcomes will be used to determine whether progression to a future definitive randomized controlled trial is justified.
The primary exploratory outcome is change in psychological distress related to self-disorders, measured using the Psychological Outcome Profiles for Self-Disorders (PSYCHLOPS-SD). Secondary exploratory outcomes include personal recovery, well-being, perceived stress, suicidal ideation, functioning, symptom severity, insight, and self-disorders.
Outcome assessments will be conducted at baseline before randomization (T0), at 16 weeks post-allocation (T1), and at follow-up 26 weeks post-allocation (T2). Data collection includes clinician-rated assessments and participant-reported questionnaires. The PhD investigator conducting baseline and follow-up clinician-rated assessments will remain blinded to treatment allocation, whereas therapists and participants cannot be blinded because of the nature of the study. Statistical analyses will be conducted by an independent statistician with treatment allocation concealed during the primary analyses.
The VITALIZE study will provide original knowledge regarding the feasibility and potential clinical utility of a phenomenologically informed psychotherapy targeting self-disorders in SSD. If SELF-7 is found to be feasible and supported by improvements in exploratory outcomes, the findings may inform the design, outcome selection, and sample size calculation of a future definitive randomized controlled trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SELF-7 psychotherapeutic intervention as add-on to standard outpatient Flexible Assertive Community Treatment (F-ACT)
Other: SELF-7 · Other: F-ACT
Standard outpatient Flexible Assertive Community Treatment (F-ACT) alone
Other: F-ACT
SELF-7 is a manualized, phenomenologically informed psychotherapeutic intervention with integrated psychoeducational components targeting self-disorders in schizophrenia spectrum disorders. The intervention is delivered according to a manual comprising seven therapeutic modules and constitutes a therapeutic framework that supports patients' awareness, understanding, and coping with difficulties related to self-disorders. While manualized, the therapeutic process is flexible and may move back and forth between modules to meet individual patient needs. SELF-7 aims to support coherence in self-experience, strengthen adaptive coping, and facilitate change. The intervention consists of 12 individual psychotherapy sessions preceded by an Examination of Anomalous Self-Experience (EASE) interview and is delivered as an add-on to standard Flexible Assertive Community Treatment (F-ACT).
Flexible Assertive Community Treatment (F-ACT) is the standard outpatient treatment provided in the participating mental health services. F-ACT includes medical consultations, regular contact with a designated case manager, and network and coordination meetings. The model is flexible, allowing the intensity of care, including consultations and home visits, to be increased according to clinical need. Participants continue receiving F-ACT throughout the study period.
Acceptability
Acceptance of study participation. Defined as the proportion of eligible participants who provide written informed consent and are subsequently randomized. This outcome assesses the feasibility of recruitment procedures and the acceptability of trial participation among the target population. Feasibility will be considered acceptable if at least 50% of eligible patients are enrolled and randomized.
Time frame: From eligibility assessment to randomization
Adherence
Adherence to the SELF-7 psychotherapeutic intervention. Defined as the proportion of participants allocated to SELF-7 who complete at least 10 psychotherapy sessions. This outcome assesses feasibility of intervention delivery and participant engagement with treatment. Feasibility will be considered acceptable if at least 70% of intervention participants complete a minimum of 10 sessions.
Time frame: From inclusion (week 0) to end-of-therapy (week 16)
Patient Satisfaction
Patient satisfaction with the SELF-7 intervention assessed using the Client Satisfaction Questionnaire-8 (CSQ-8) at end of therapy (week 16). The CSQ-8 is an 8-item self-report measure of perceived quality, usefulness, and acceptability of care. Higher scores indicate greater satisfaction with treatment. Feasibility will be considered acceptable if at least 70% of participants achieve a mean CSQ-8 score greater than 3.5.
Time frame: At end of therapy (week 16)
Participant Evaluation
Participant evaluation of the SELF-7 intervention assessed using the purpose-developed patient version of SELF-7 Treatment Feedback Scale (STFS). The patient version of STFS is a 4-item participant-rated measure assessing perceived therapeutic understanding, relevance of therapeutic content, usefulness of the therapeutic approach, and overall benefit of SELF-7 for understanding and managing self-disorders. Items are rated on an 11-point scale ranging from 0 ("not at all") to 10 ("to a very high degree"). Mean scores range from 0 to 10, with higher scores indicating more positive evaluations and greater acceptability of the intervention. Feasibility will be considered acceptable if at least 70% of participants provide overall positive feedback.
Time frame: End of therapy (week 16)
Therapist Evaluation
Therapist evaluation of the SELF-7 intervention assessed using the purpose-developed terapist version of SELF-7 Treatment Feedback Scale (STFS). The terapist version of STFS is a 4-item therapist-rated measure assessing therapeutic alliance and collaboration, relevance of therapy content, appropriateness of the therapeutic approach, and the overall contribution of SELF-7 to the patient's understanding and management of self-disorders. Items are rated on an 11-point scale ranging from 0 ("not at all") to 10 ("to a very high degree"). Mean scores range from 0 to 10, with higher scores indicating more positive evaluations and greater acceptability of the intervention. Feasibility will be considered acceptable if at least 70% of therapists provide overall positive feedback.
Time frame: At end of therapy (week 16)
Adverse Effects
Therapy-related adverse effects will be assessed at end of therapy using the Negative Effects Questionnaire (NEQ-20), a 20-item self-report measure designed to assess unwanted and adverse effects associated with psychological treatment. The NEQ-20 will be used to evaluate the safety and tolerability of the SELF-7 intervention, alongside monitoring of serious therapy-related adverse events. Items are rated on a 5-point scale, and mean scores range from 0 to 4, with higher scores indicating more frequent and/or severe negative effects of treatment. A mean score of 0 indicates no reported negative effects, whereas a mean score of 4 indicates the highest level of reported negative effects. The adverse effects criterion is met if no more than one serious therapy-related adverse event (as defined in the protocol) occurs during the intervention period (week 0 - week 16) and if fewer than 10% of participants have a mean NEQ-20 score greater than 2 measured at end of therapy (week 16).
Time frame: From inclusion (week 0) until end of therapy (week 16)
Psychological Outcome Profiles (PSYCHLOPS)
Psychological Outcome Profiles (PSYCHLOPS), an individualized idiographic patient-reported outcome measure (I-PROM) that measures psychological distress, and will serve as the primary exploratory outcome. PSYCHLOPS includes four items covering three domains: (1) Problems; (2) Function; and (3) Well-being. A six-point rating scale is used to score the intensity and duration of psychological distress. PSYCHLOPS is adapted to assess psychological distress related to self-disorders, as participants follow a structured procedure that guides them in identifying and rating their main self-defined psychological problems and associated distress related to self-disorder phenomena. Higher scores indicate greater psychological distress related to self-disorders.
Time frame: T0 (baseline pre-allocation), T1 (16 weeks post-allocation), and T2 (26 weeks post-allocation)
Readiness for Psychotherapy (RPI)
The RPI is a self-report measure to assess seven dimensions of readiness for psychotherapy: level of distress, desire for change, willingness to work in therapy, recognition of problems as psychological, willingness to discuss personal matters, willingness to endure discomfort in therapy, and responsibility for change. 42 items; 5-point Likert scale. 7 subscales; total score and subscale scores are analyzed; higher scores indicate greater readiness.
Time frame: Baseline (pre-allocation)
Personal Recovery (Brief INSPIRE-O)
The Brief INSPIRE-O is a patient-reported outcome measure assessing personal recovery across the domains of connectedness, hope, identity, meaning, and empowerment (CHIME). The instrument consists of 10 items covering five domains, rated on a 5-point Likert scale. Total scores range from 10 to 50. Higher scores indicate greater perceived personal recovery.
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The WHO Well-Being Index (WHO-5)
The WHO Well-Being Index (WHO-5) is a self-report measure of current subjective psychological well-being. The instrument consists of 5 items rated on a 6-point Likert scale. Raw scores range from 0 to 25 and are transformed to a scale ranging from 0 to 100. Higher scores indicate better well-being.
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS-10) is a self-report questionnaire assessing the degree to which individuals perceive their lives as stressful, unpredictable, and overloaded during the past month. The instrument consists of 10 items rated on a 5-point Likert scale. Total scores range from 0 to 40. Higher scores indicate greater perceived stress.
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The Suicidal Ideation Attributes Scale (SIDAS)
The Suicidal Ideation Attributes Scale (SIDAS) is a self-report measure assessing the severity and impact of suicidal ideation, including frequency, controllability, distress, and interference with daily functioning. The instrument consists of 5 items rated on 11-point scales. Total scores range from 0 to 50. Higher scores indicate greater suicidal ideation severity.
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The Personal and Social Performance Scale (PSP)
The Personal and Social Performance Scale (PSP) is a clinician-rated measure assessing functioning across four domains: socially useful activities, personal and social relationships, self-care, and disturbing/aggressive behaviors. Total scores range from 1 to 100. Higher scores indicate better personal and social functioning.
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Scale for the Assessment of Positive Symptoms (SAPS)
The Scale for the Assessment of Positive Symptoms (SAPS) is a clinician-rated instrument assessing the severity of positive psychotic symptoms, including hallucinations, delusions, bizarre behavior, and positive formal thought disorder. The instrument consists of 34 items across four global domains and includes both item-level and global domain ratings. Items are rated on a 6-point scale (0-5). Higher scores indicate greater positive symptom severity, with a score of 0 reflecting the absence of positive symptoms and higher scores reflecting increasing symptom severity.
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Brief Negative Symptom Scale (BNSS)
The Brief Negative Symptom Scale (BNSS) is a clinician-rated scale assessing core negative symptom domains, including anhedonia, asociality, avolition, blunted affect, and alogia. The instrument consists of 13 items across five domains. Each item is rated on a 7-point scale (0-6), yielding a total score ranging from 0 to 78, with higher scores indicating greater negative symptom severity. A score of 0 reflects the absence of negative symptoms, whereas higher scores reflect increasing severity of negative symptoms. Total and domain scores will be analyzed.
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Positive and Negative Syndrome Scale (PANSS) Item G12
Insight assessed using Item G12 from the Positive and Negative Syndrome Scale (PANSS). G12 is a clinician-rated item evaluating awareness and understanding of having a mental illness, recognition of symptoms as pathological, and appreciation of the need for treatment. Scores range from 1 to 7. Higher scores indicate poorer insight and greater lack of judgment.
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Examination of Anomalous Self-Experience (EASE)
The Examination of Anomalous Self-Experience (EASE) is a semi-structured interview comprising 57 main items distributed across five domains: Cognition and stream of consciousness, Self-awareness and presence, Bodily experiences, Demarcation/transitivism, and Existential reorientation/solipsism. Items are rated dichotomously as present or absent. Scores are summed into an EASE total score, where 1 point corresponds to the presence of 1 self-disorder item. Higher scores indicate greater levels of self-disorders.
Time frame: Baseline (pre-allocation) and follow-up (week 26)
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in publications from the VITALIZE study may be shared after publication of the primary study results. Shared data may include participant-level data from feasibility and exploratory outcome measures, together with a data dictionary and relevant study documentation. Data will be fully de-identified prior to sharing to protect participant confidentiality and will be shared in accordance with applicable Danish data protection regulations, ethical approvals, and institutional policies. Data containing information that could increase the risk of participant re-identification will not be shared. The study is conducted in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act. Requests for access to de-identified individual participant data should be directed to the Principal Investigator or study team. Data may be available upon request under a data-sharing agreement.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 27 months is below that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Psychiatric Research Unit, Region Zealand, Denmark