- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06597864
Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study (SSPP-SD-p)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tor Gunnar Værnes, Dr.philos.
- Phone Number: 0047 92 45 56 78
- Email: uxvrnt@ous-hf.no
Study Contact Backup
- Name: Paul Møller, Dr.Med.
- Phone Number: 0047 91 17 60 84
- Email: Paul.Moller@vestreviken.no
Study Locations
-
-
-
Oslo, Norway
- Completed
- Akershus University Hospital
-
-
Bærum
-
Sandvika, Bærum, Norway, 1338
- Recruiting
- Bærum DPS
-
Contact:
- Lise Baklund, PhD
- Phone Number: 0047 91542993
- Email: Lise.Baklund@vestreviken.no
-
Sub-Investigator:
- Lise Baklund, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Other: Psychotherapy group
Single arm of participants receiving a phenomenologically oriented psychotherapeutic intervention
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Tor Gunnar Værnes, Dr.philos., Oslo University Hospital, Early Intervention in Psychosis Advisory Unit for South-East Norway
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 750920
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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