Psychotherapy for Self-Disorders in Schizophrenia Spectrum Disorder

Schizophrenia spectrum disorders (SSD) are associated with self-disorders, a group of non-psychotic, trait-like phenomena considered close to the psychopathological core of SSD. Systematic reviews and meta-analyses have consistently demonstrated high levels of self-disorders in individuals with SSD. Although cognitive behavioral therapy (CBT) is recommended as an adjunctive psychological treatment for schizophrenia, meta-analytic evidence suggests that its efficacy is limited. It has been proposed that this may reflect a mismatch between psychotherapeutic approach and the psychopathological core of SSD. Consequently, there is a need to develop and evaluate psychotherapeutic interventions that are more closely tailored to these core features. SELF-7 is a novel, manualized, phenomenologically informed psychotherapeutic intervention with integrated psychoeducational components targeting self-disorders in SSD. The intervention was developed from the Seven Step Phenomenological Psychotherapy for Self-Disorder (SSPP-SD), drawing on extensive clinical experience in Norway and further refined through pilot projects conducted in Norway and Denmark. SELF-7 is delivered according to a manual comprising seven thematic modules and is designed to support patients' awareness, understanding, and coping with difficulties related to self-disorders, while strengthening adaptive coping, facilitating change, and supporting coherence in self-experience. The VITALIZE study is a two-arm, parallel, randomized controlled feasibility trial investigating SELF-7 as an add-on to standard outpatient treatment delivered through Flexible Assertive Community Treatment (F-ACT) teams. The primary objective is to examine the feasibility of SELF-7 for patients with SSD in an outpatient setting. The secondary objective is to explore preliminary clinical effects of the intervention. Forty adult patients with schizophrenia (ICD-10 F20.x) or schizotypal disorder (ICD-10 F21) who have been discharged from OPUS, an early intervention outpatient programme, within the previous five years and are currently receiving treatment in an F-ACT team will be randomized in a 1:1 ratio to either SELF-7 plus F-ACT or F-ACT alone. Participants allocated to SELF-7 will receive 12 sessions of individual psychotherapy preceded by an Examination of Anomalous Self-Experience (EASE) interview. Therapy will be delivered by trained research therapists while participants continue to receive standard F-ACT throughout the intervention period. Participants allocated to the control group will continue receiving F-ACT alone. As the primary aim of the study is to assess feasibility, feasibility outcomes constitute the primary trial outcomes. Feasibility will be evaluated across five predefined domains: acceptability, adherence, patient satisfaction, patient and therapist evaluations, and adverse events. These outcomes will be used to determine whether progression to a future definitive randomized controlled trial is justified. The primary exploratory outcome is change in psychological distress related to self-disorders, measured using the Psychological Outcome Profiles for Self-Disorders (PSYCHLOPS-SD). Secondary exploratory outcomes include personal recovery, well-being, perceived stress, suicidal ideation, functioning, symptom severity, insight, and self-disorders. Outcome assessments will be conducted at baseline before randomization (T0), at 16 weeks post-allocation (T1), and at follow-up 26 weeks post-allocation (T2). Data collection includes clinician-rated assessments and participant-reported questionnaires. The PhD investigator conducting baseline and follow-up clinician-rated assessments will remain blinded to treatment allocation, whereas therapists and participants cannot be blinded because of the nature of the study. Statistical analyses will be conducted by an independent statistician with treatment allocation concealed during the primary analyses. The VITALIZE study will provide original knowledge regarding the feasibility and potential clinical utility of a phenomenologically informed psychotherapy targeting self-disorders in SSD. If SELF-7 is found to be feasible and supported by improvements in exploratory outcomes, the findings may inform the design, outcome selection, and sample size calculation of a future definitive randomized controlled trial.