Schizophrenia Spectrum Disorders (SSD)VITALIZENCT07841418
Psychotherapy for Self-Disorders in Schizophrenia Spectrum Disorder
A study testing SELF-7 and F-ACT in people with Schizophrenia Spectrum Disorders (SSD), run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia Spectrum Disorders (SSD)
- What is being tested?
- SELF-7 and F-ACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years.
- Capacity to understand study procedures and provide written informed consent.
- ICD-10 diagnosis of schizophrenia (F20.x) or schizotypal disorder (F21).
- Receiving treatment in a Flexible Assertive Community Treatment (F-ACT) team.
- Discharged from the OPUS early intervention outpatient programme within the past 5 years.
- Clinically stable with regard to antipsychotic treatment (receiving antipsychotic medication or not receiving antipsychotic medication) and with no planned substantial changes in antipsychotic treatment at the time of inclusion.
Who cannot join
- Insufficient proficiency in Danish to participate in psychotherapy and complete study assessments.
- Current severe alcohol or substance dependence.
- Current forensic psychiatric status.
- Clinically assessed elevated risk of severe self-harm, suicide, or harm to others.
- Severe comorbid somatic illness or severe comorbid psychiatric disorder that substantially compromises the ability to participate in psychotherapy.
- Not deemed able to participate in psychotherapy based on clinical judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Psychiatric Research Unit, Mental Health Services Region Zealand
Slagelse, Region Sjælland, 4200
Sidse Marie Arnfred, Professor, + 45 - 24227045, sidar@regionsjaelland.dk
Toke Lenskjold, MD, +45 - 31667874, toul@regionsjaelland.dk
About this study
Official title: Psychotherapy for Abnormalities of Self-VITALITY in Patients With Schizophrenia Spectrum Disorder: A Feasibility RCT [VITALIZE]
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).
Read the detailed description
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.
- Conditions
- Schizophrenia Spectrum Disorders (SSD)
- Being tested
- SELF-7, F-ACT
- Keywords
- Schizophrenia Spectrum Disorders, Self-Disorders, SELF-7, Psychotherapy, Phenomenology, Flexible Assertive Community Treatment, Psychological distress, Feasibility Trial, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SELF-7Other
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).
F-ACTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SELF-7 Intervention + F-ACT | Experimental | SELF-7 psychotherapeutic intervention as add-on to standard outpatient Flexible Assertive Community Treatment (F-ACT) Receives: Other: SELF-7; Other: F-ACT |
| F-ACT alone | Active comparator | Standard outpatient Flexible Assertive Community Treatment (F-ACT) alone Receives: Other: F-ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From inclusion (week 0) until end of therapy (week 16)
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-allocation) and follow-up (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum Disorders (SSD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidse Arnfred, Psychiatric Research Unit, Region Zealand, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841418
- Sponsor's protocol ID
- SJ-1139
- Other IDs
- 4309-00072B
- Acronym
- VITALIZE
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Abnormalities of Self-VITALITY in Patients With Schizophrenia Spectrum Disorder: A Feasibility RCT [VITALIZE]
- ClinicalTrials.gov ID
- NCT07841418
- Acronym / sponsor ID
- VITALIZE / SJ-1139
- Conditions
- Schizophrenia Spectrum Disorders (SSD)
- Keywords
- Schizophrenia Spectrum Disorders, Self-Disorders, SELF-7, Psychotherapy, Phenomenology, Flexible Assertive Community Treatment, Psychological distress, Feasibility Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Sep 2026 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SELF-7 Intervention + F-ACT | Experimental | Other: SELF-7, Other: F-ACTSELF-7 psychotherapeutic intervention as add-on to standard outpatient Flexible Assertive Community Treatment (F-ACT) |
| F-ACT alone | Active comparator | Other: F-ACTStandard outpatient Flexible Assertive Community Treatment (F-ACT) alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Capacity to understand study procedures and provide written informed consent.
- ICD-10 diagnosis of schizophrenia (F20.x) or schizotypal disorder (F21).
- Receiving treatment in a Flexible Assertive Community Treatment (F-ACT) team.
- Discharged from the OPUS early intervention outpatient programme within the past 5 years.
Key exclusion criteria (6 listed)
- Insufficient proficiency in Danish to participate in psychotherapy and complete study assessments.
- Current severe alcohol or substance dependence.
- Current forensic psychiatric status.
- Clinically assessed elevated risk of severe self-harm, suicide, or harm to others.
- Severe comorbid somatic illness or severe comorbid psychiatric disorder that substantially compromises the ability to participate in psychotherapy.
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 |
|---|---|---|
| SELF-7SELF-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). | Other | SELF-7 Intervention + F-ACT |
| F-ACTFlexible 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. | Other | F-ACT alone, SELF-7 Intervention + F-ACT |
Primary outcome
Acceptability
Time frame: From eligibility assessment to randomization
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.
Adherence
Time frame: From inclusion (week 0) to end-of-therapy (week 16)
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.
Patient Satisfaction
Time frame: At end of therapy (week 16)
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.
Participant Evaluation
Time frame: End of therapy (week 16)
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.
Therapist Evaluation
Time frame: At end of therapy (week 16)
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.
Adverse Effects
Time frame: From inclusion (week 0) until end of therapy (week 16)
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).
11 secondary outcomes
Psychological Outcome Profiles (PSYCHLOPS)
Time frame: T0 (baseline pre-allocation), T1 (16 weeks post-allocation), and T2 (26 weeks post-allocation)
Readiness for Psychotherapy (RPI)
Time frame: Baseline (pre-allocation)
Personal Recovery (Brief INSPIRE-O)
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The WHO Well-Being Index (WHO-5)
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The Perceived Stress Scale (PSS-10)
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The Suicidal Ideation Attributes Scale (SIDAS)
Time frame: Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)
The Personal and Social Performance Scale (PSP)
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Scale for the Assessment of Positive Symptoms (SAPS)
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Brief Negative Symptom Scale (BNSS)
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Positive and Negative Syndrome Scale (PANSS) Item G12
Time frame: Baseline (pre-allocation) and follow-up (week 26)
The Examination of Anomalous Self-Experience (EASE)
Time frame: Baseline (pre-allocation) and follow-up (week 26)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELF-7 and F-ACT in people with Schizophrenia Spectrum Disorders (SSD), run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toke Lenskjold (+45 - 31667874, toul@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: From eligibility assessment to randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.