Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study (SSPP-SD-p)

December 2, 2025 updated by: Tor Gunnar Værnes, Oslo University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tor Gunnar Værnes, Dr.philos.
  • Phone Number: 0047 92 45 56 78
  • Email: uxvrnt@ous-hf.no

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway
        • Completed
        • Akershus University Hospital
    • Bærum
      • Sandvika, Bærum, Norway, 1338
        • Recruiting
        • Bærum DPS
        • Contact:
        • Sub-Investigator:
          • Lise Baklund, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Severe, ongoing psychosis
  • Severe, ongoing drug abuse
  • IQ<70
  • Poor Norwegian language profiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Psychotherapy group
Single arm of participants receiving a phenomenologically oriented psychotherapeutic intervention
Behavioral: Seven-step phenomenological psychotherapy for self-disorders
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After completing the SSPP-SD treatment, up to 12 weeks after study inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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.
After end of SSPP-SD treatment, up to 12 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vestre Viken Hospital Trust
University Hospital, Akershus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tor Gunnar Værnes, Dr.philos., Oslo University Hospital, Early Intervention in Psychosis Advisory Unit for South-East Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 750920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the qualitative, phenomenological design, and the small number of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings