Clinical trial NCT06597864: Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study
Official title: Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychosis;Schizophrenic
Keywords: self-disorder
psychotherapy
phenomenology
qualitative
schizophrenia spectrum
psychosis risk syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
First posted: 2024-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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, \&amp; 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\&lt;70
* Poor Norwegian language profiency

Primary outcomes:
measure: Experience of the seven-step phenomenological psychotherapy model for self-disorders
timeFrame: After completing the SSPP-SD treatment, up to 12 weeks after study inclusion
Secondary outcomes:
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
measure: Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
timeFrame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
measure: Positive and Negative Syndrome Scale-6 (PANSS-6)
timeFrame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
measure: 10-point self-disorder questionnaire
timeFrame: Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment
measure: Examination of Anomalous Self-Experience (EASE)
timeFrame: During the first of sevens steps of treatment, session 1 and 2. Up to 3 weeks after study enrollment
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: After end of SSPP-SD treatment, up to 12 weeks after enrollment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: Oslo University Hospital, Early Intervention in Psychosis Advisory Unit for South-East Norway
name: Tor Gunnar Værnes, Dr.philos.
role: PRINCIPAL_INVESTIGATOR
References: