NCT06597864

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

October 17, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

September 9, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

self-disorderpsychotherapyphenomenologyqualitativeschizophrenia spectrumpsychosis risk syndrome

Outcome Measures

Primary Outcomes (1)

  • Experience of the seven-step phenomenological psychotherapy model for self-disorders

    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 Outcomes (8)

  • General Anxiety Disorder-7 (GAD-7)

    Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment

  • Patient Health Questionnaire-9 (PHQ-9)

    Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment

  • Work and Social Adjustment Scale (WSAS)

    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)

    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)

    Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment

  • +3 more secondary outcomes

Study Arms (1)

Psychotherapy group

OTHER

Single arm of participants receiving a phenomenologically oriented psychotherapeutic intervention

Behavioral: Seven-step phenomenological psychotherapy for self-disorders

Interventions

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

Psychotherapy group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bærum DPS

Sandvika, Bærum, 1338, Norway

RECRUITING

Akershus University Hospital

Oslo, Norway

COMPLETED

Study Officials

  • Tor Gunnar Værnes, Dr.philos.

    Oslo University Hospital, Early Intervention in Psychosis Advisory Unit for South-East Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tor Gunnar Værnes, Dr.philos.

CONTACT

Paul Møller, Dr.Med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

October 17, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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

Locations