Psychosis;SchizophrenicSSPP-SD-pNCT06597864
Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study
A study testing Seven-step phenomenological psychotherapy for self-disorders in people with Psychosis;Schizophrenic, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The goal of this clinical pilot study is to learn how adults with schizophrenia or other non-affective psychotic disorders or psychosis risk syndromes experience a novel psychotherapeutic treatment for self-disorders. The study has a qualitative, phenomenological research design. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Psychosis;Schizophrenic
- What is being tested?
- Seven-step phenomenological psychotherapy for self-disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesNorway
- Study dates
- 17 Oct 2024to 1 Mar 2026
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnoses in the ICD-10-CM Code range, i.e. schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders. First diagnosed no more than 3 years ago.
- Or Psychosis risk syndrome as defined in the Structured Interview of Psychosis-Risk Syndromes (SIPS) (McGlashan, Walsh, \& Woods, 2010)
- Present with anomalous self-experiences, as confirmed by the Screen Questionnaire for EASE (SQuEASE-6) (Møller, 2018)
- Motivated to explore and work with anomalous self-experiences in psychotherapy
Who cannot join
- Severe, ongoing psychosis
- Severe, ongoing drug abuse
- IQ\<70
- Poor Norwegian language profiency
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 1 recruiting
- Completed
Akershus University Hospital
Oslo
- Recruiting
Bærum DPS
Sandvika, Bærum, 1338
Lise Baklund, PhD, 0047 91542993, Lise.Baklund@vestreviken.no
Lise Baklund, PhD
About this study
The goal of this clinical pilot study is to learn how adults with schizophrenia or other non-affective psychotic disorders or psychosis risk syndromes experience a novel psychotherapeutic treatment for self-disorders. The study has a qualitative, phenomenological research design. After end of treatment, the participants are interviewed about the experience of the treatment. This include how the participants liked it, if it was experienced as helpful and useful, and changes in self-experience and experience of relations to others and the world.
Read the detailed description
Self-disorders are considered as central features of schizophrenia spectrum disorders which may be present both before, during, and after psychotic episodes. They are characterized by disturbances in the sense of ownership to experiences and agency of action, as well as in the sense of presence, reality and existence. They are further considered to drive symptom development during prodromal schizphrenia. Self-disorders may be very painful, and associated with anxiety, disturbances in daily functioning and increased sucidality. There is a lack of studies investigating the effect of psychotherapy on self-disorders. Hence, there is a need for developing and testing new treatment approaches to these debilitating conditions.
In this pilot study the investigators want to test a new model and manual for the treatment of self-disorders, the Seven-Step Phenomenological Psychotherapy for Self-Disorder (SSPP-SD), first developed by Dr.Med Paul Møller. This model focuses on the phenomenological exploration of self-disorders, subjective understanding, meaning and associated behaviors, psychoeducation, and the joint exploration of new meanings and understanding related to the experiences. The length of the treatment is stipulated to 14 individual sessions over 7-10 weeks. The first step of the treatment involves a semi-structured interview with the Examination of Anomalous Self-Experience (EASE).
The study has a qualitative phenomenological design where the primary research question is how the participants experienced the treatment. In more detail, the investigators want to explore both positive and negative experiences, how useful or helpful the participants experienced the treatment, and how the treatment affected self-experience and experience of relations to others and the world. These experiences will be explored in a qualitative interview following the end of treatment. In addition, the participants will answer questionnaires regarding symptoms, functioning, life quality (before and after treatment) and satisfaction with the treatment (after treatment). The study will inform the planning of a larger clinical trial testing the effect of the SSPP-SD on self-disorders in participants with psychotic disorders at Vestre Viken Hospital, Norway. Hence, in this pilot study the investigators will also register and evaluate therapist experiences of the SSPP-SD, and fidelity to the manual. The therapists will be supervised by Dr.med Paul Møller.
Six participants with schizophrenia or other ICD-10 F20-29 disorders, or with psychosis risk syndromes as defined in the Structured Interview for Psychosis-risk Syndromes (SIPS) will be included. They will be included from an outpatient clinic for psychotic disorders at Akershus University Hospital, Norway. Two experienced therapists trained in the model will offer the therapy, including project leader Dr. Tor Gunnar Værnes at the Oslo University Hospital.
- Conditions
- Psychosis;Schizophrenic
- Being tested
- Seven-step phenomenological psychotherapy for self-disorders
- Keywords
- self-disorder, psychotherapy, phenomenology, qualitative, schizophrenia spectrum, psychosis risk syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seven-step phenomenological psychotherapy for self-disordersBehavioural
Phenomenological exploration of anomalous self-experiences, meaning attributions and behavioral consequences. Psychoeducation. Dialogical approach focusing on self-narratives, searching for new meaning and understanding of self-disorders
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy group | Other | Single arm of participants receiving a phenomenologically oriented psychotherapeutic intervention Receives: Behavioral: Seven-step phenomenological psychotherapy for self-disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of the seven-step phenomenological psychotherapy model for self-disorders
Qualitative, semi-structured interview exploring how the participants experienced the therapy.
Measured: After completing the SSPP-SD treatment, up to 12 weeks after study inclusion
Secondary outcomes (8)
General Anxiety Disorder-7 (GAD-7)
Self-report of anxiety symptoms scored on a 0-3 Likert scale. Min-max score on the total scale: 0-21. Higher scores reflect more severe symptoms/outcome
Measured: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Patient Health Questionnaire-9 (PHQ-9)
Self-report of 9 depression symptoms. Each symptom scored on a 0-3 Likert scale. Min-max scores 0-27. Higher scores imply a more severe outcome
Measured: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Work and Social Adjustment Scale (WSAS)
Self-report measure for impairment in social and work functioning and adjustment. It includes 5 items to be scored on a 0-8 Likert scale. Min-max score 0-40. Higher scores imply a more severe outcome
Measured: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Self-report measure for mental well-being. It includes 14 items each scored on a 1-5 Likert scale. Min-max score: 14-70. Higher scores imply a more severe outcome.
Measured: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Positive and Negative Syndrome Scale-6 (PANSS-6)
Brief rating scale for the measurement of severity in schizophrenia. A semi-structured interview assessing 3 positive and 3 negative symptoms. Each symptom scored on a 1-7 Likert scale. Min-max total score: 6-42. Higher scores imply more severe outcomes
Measured: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
10-point self-disorder questionnaire
Brief rating scale for the measurement of self-disorders. It includes 10 items, each scored on a 0-4 Likert scale. Min-max score 0-40. Higher scores imply a more severe outcome
Measured: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Examination of Anomalous Self-Experience (EASE)
Semi-structured interview for a qualitative exploration and quantitative assessment of anomalous self-experiences. It includes 57 main items, each scored on a 0-4 Likert scale (it also include a range of subitems which are scored on a 0-4 Likert scale, but the scores on these subitems are not included in the total EASE score). Min-max total score 0-228. Higher scores imply more severe outcomes
Measured: During the first of sevens steps of treatment, session 1 and 2. Up to 3 weeks after study enrollment
Client Satisfaction Questionnaire (CSQ-8)
Self-report measure of satisfaction with health-care, including 5 questions. Each question scored on a 0-4 Likert scale. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: After end of SSPP-SD treatment, up to 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Oct 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis;SchizophrenicStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Tor Gunnar Værnes, Oslo University Hospital
- Investigators
- Tor Gunnar Værnes, Dr.philos., Principal investigator, Oslo University Hospital, Early Intervention in Psychosis Advisory Unit for South-East Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597864
- Sponsor's protocol ID
- 750920
- Acronym
- SSPP-SD-p
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the qualitative, phenomenological design, and the small number of participants
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study
- ClinicalTrials.gov ID
- NCT06597864
- Acronym / sponsor ID
- SSPP-SD-p / 750920
- Conditions
- Psychosis;Schizophrenic
- Keywords
- self-disorder, psychotherapy, phenomenology, qualitative, schizophrenia spectrum, psychosis risk syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Vestre Viken Hospital Trust
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 19 Sep 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.
The goal of this clinical pilot study is to learn how adults with schizophrenia or other non-affective psychotic disorders or psychosis risk syndromes experience a novel psychotherapeutic treatment for self-disorders. The study has a qualitative, phenomenological research design. After end of treatment, the participants are interviewed about the experience of the treatment. This include how the participants liked it, if it was experienced as helpful and useful, and changes in self-experience and experience of relations to others and the world.
Detailed description
Self-disorders are considered as central features of schizophrenia spectrum disorders which may be present both before, during, and after psychotic episodes. They are characterized by disturbances in the sense of ownership to experiences and agency of action, as well as in the sense of presence, reality and existence. They are further considered to drive symptom development during prodromal schizphrenia. Self-disorders may be very painful, and associated with anxiety, disturbances in daily functioning and increased sucidality. There is a lack of studies investigating the effect of psychotherapy on self-disorders. Hence, there is a need for developing and testing new treatment approaches to these debilitating conditions.
In this pilot study the investigators want to test a new model and manual for the treatment of self-disorders, the Seven-Step Phenomenological Psychotherapy for Self-Disorder (SSPP-SD), first developed by Dr.Med Paul Møller. This model focuses on the phenomenological exploration of self-disorders, subjective understanding, meaning and associated behaviors, psychoeducation, and the joint exploration of new meanings and understanding related to the experiences. The length of the treatment is stipulated to 14 individual sessions over 7-10 weeks. The first step of the treatment involves a semi-structured interview with the Examination of Anomalous Self-Experience (EASE).
The study has a qualitative phenomenological design where the primary research question is how the participants experienced the treatment. In more detail, the investigators want to explore both positive and negative experiences, how useful or helpful the participants experienced the treatment, and how the treatment affected self-experience and experience of relations to others and the world. These experiences will be explored in a qualitative interview following the end of treatment. In addition, the participants will answer questionnaires regarding symptoms, functioning, life quality (before and after treatment) and satisfaction with the treatment (after treatment). The study will inform the planning of a larger clinical trial testing the effect of the SSPP-SD on self-disorders in participants with psychotic disorders at Vestre Viken Hospital, Norway. Hence, in this pilot study the investigators will also register and evaluate therapist experiences of the SSPP-SD, and fidelity to the manual. The therapists will be supervised by Dr.med Paul Møller.
Six participants with schizophrenia or other ICD-10 F20-29 disorders, or with psychosis risk syndromes as defined in the Structured Interview for Psychosis-risk Syndromes (SIPS) will be included. They will be included from an outpatient clinic for psychotic disorders at Akershus University Hospital, Norway. Two experienced therapists trained in the model will offer the therapy, including project leader Dr. Tor Gunnar Værnes at the Oslo University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy group | Other | Behavioral: Seven-step phenomenological psychotherapy for self-disordersSingle arm of participants receiving a phenomenologically oriented psychotherapeutic intervention |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnoses in the ICD-10-CM Code range, i.e. schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders. First diagnosed no more than 3 years ago.
- Or Psychosis risk syndrome as defined in the Structured Interview of Psychosis-Risk Syndromes (SIPS) (McGlashan, Walsh, \& Woods, 2010)
- Present with anomalous self-experiences, as confirmed by the Screen Questionnaire for EASE (SQuEASE-6) (Møller, 2018)
- Motivated to explore and work with anomalous self-experiences in psychotherapy
Key exclusion criteria (4 listed)
- Severe, ongoing psychosis
- Severe, ongoing drug abuse
- IQ\<70
- Poor Norwegian language profiency
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 |
|---|---|---|
| Seven-step phenomenological psychotherapy for self-disordersPhenomenological exploration of anomalous self-experiences, meaning attributions and behavioral consequences. Psychoeducation. Dialogical approach focusing on self-narratives, searching for new meaning and understanding of self-disorders | Behavioural | Psychotherapy group |
Primary outcome
Experience of the seven-step phenomenological psychotherapy model for self-disorders
Time frame: After completing the SSPP-SD treatment, up to 12 weeks after study inclusion
Qualitative, semi-structured interview exploring how the participants experienced the therapy.
8 secondary outcomes
General Anxiety Disorder-7 (GAD-7)
Time frame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Work and Social Adjustment Scale (WSAS)
Time frame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Time frame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Positive and Negative Syndrome Scale-6 (PANSS-6)
Time frame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
10-point self-disorder questionnaire
Time frame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
Examination of Anomalous Self-Experience (EASE)
Time frame: During the first of sevens steps of treatment, session 1 and 2. Up to 3 weeks after study enrollment
Client Satisfaction Questionnaire (CSQ-8)
Time frame: After end of SSPP-SD treatment, up to 12 weeks after enrollment
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 9 Dec 2025.
- Individual participant dataSharing planned: No. Due to the qualitative, phenomenological design, and the small number of participants
Related trials for Psychosis;Schizophrenic
RecruitingPhase 1
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
Schizophrenia, Schizo-Affective Disorder
Recruiting
Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder
Schizophrenia
Active, not recruiting
Effect of Melatonin on Schizophrenic Symptoms: a Randomized Placebo-Controlled Trial
Schizophrenia Disorders, Psychotic Disorder
Not yet recruitingObservational study
Functional Magnetic Resonance Imaging Study in Schizophrenia Patients and Correlation With Cognitive Impairments
Schizophrenia, Cognitive Impairment
Recruiting
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients
Schizophrenia
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.
Tor Gunnar Værnes, Dr.philos. principal investigator
Oslo University Hospital, Early Intervention in Psychosis Advisory Unit for South-East Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seven-step phenomenological psychotherapy for self-disorders in people with Psychosis;Schizophrenic, run by Oslo University Hospital at 2 sites in Norway.
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 4 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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 Norway. 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 Tor Gunnar Værnes, Dr.philos. (0047 92 45 56 78, uxvrnt@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of the seven-step phenomenological psychotherapy model for self-disorders (time frame: After completing the SSPP-SD treatment, up to 12 weeks after study inclusion). 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 9 Dec 2025.