Psychotherapy for Self-Disorders in Schizophrenia Spectrum Disorder

NCT07841418 | Not Yet Recruiting

• 2 other identifiers: SJ-11394309-00072B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the VITALIZE study is to evaluate the feasibility of SELF-7, a novel phenomenologically informed psychotherapy for self-disorders, as an add-on to standard psychiatric outpatient treatment - Flexible Assertive Community Treatment (F-ACT) - in adults with schizophrenia spectrum disorders. The main question is whether SELF-7 is feasible and acceptable in routine psychiatric outpatient care (F-ACT teams). A secondary objective of the study is to explore whether SELF-7 may reduce psychological distress related to self-disorders and improve personal recovery, well-being, functioning, perceived stress, suicidal ideation, symptom severity, insight, and self-disorders. Researchers will compare SELF-7 plus F-ACT with F-ACT alone. Participants will be randomized to one of the two groups, complete clinical interviews and questionnaires at baseline, 16 weeks, and 26 weeks, and, if allocated to SELF-7, receive 12 individual psychotherapy sessions in addition to standard care (F-ACT).

Conditions

Schizophrenia Spectrum Disorders (SSD)

Keywords

Schizophrenia Spectrum Disorders; Self-Disorders; SELF-7; Psychotherapy; Phenomenology; Flexible Assertive Community Treatment; Psychological distress; Feasibility Trial; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (6)

• Acceptability

  Acceptance of study participation. Defined as the proportion of eligible participants who provide written informed consent and are subsequently randomized. This outcome assesses the feasibility of recruitment procedures and the acceptability of trial participation among the target population. Feasibility will be considered acceptable if at least 50% of eligible patients are enrolled and randomized.

  From eligibility assessment to randomization

• Adherence

  Adherence to the SELF-7 psychotherapeutic intervention. Defined as the proportion of participants allocated to SELF-7 who complete at least 10 psychotherapy sessions. This outcome assesses feasibility of intervention delivery and participant engagement with treatment. Feasibility will be considered acceptable if at least 70% of intervention participants complete a minimum of 10 sessions.

  From inclusion (week 0) to end-of-therapy (week 16)

• Patient Satisfaction

  Patient satisfaction with the SELF-7 intervention assessed using the Client Satisfaction Questionnaire-8 (CSQ-8) at end of therapy (week 16). The CSQ-8 is an 8-item self-report measure of perceived quality, usefulness, and acceptability of care. Higher scores indicate greater satisfaction with treatment. Feasibility will be considered acceptable if at least 70% of participants achieve a mean CSQ-8 score greater than 3.5.

  At end of therapy (week 16)

• Participant Evaluation

  Participant evaluation of the SELF-7 intervention assessed using the purpose-developed patient version of SELF-7 Treatment Feedback Scale (STFS). The patient version of STFS is a 4-item participant-rated measure assessing perceived therapeutic understanding, relevance of therapeutic content, usefulness of the therapeutic approach, and overall benefit of SELF-7 for understanding and managing self-disorders. Items are rated on an 11-point scale ranging from 0 ("not at all") to 10 ("to a very high degree"). Mean scores range from 0 to 10, with higher scores indicating more positive evaluations and greater acceptability of the intervention. Feasibility will be considered acceptable if at least 70% of participants provide overall positive feedback.

  End of therapy (week 16)

• Therapist Evaluation

  Therapist evaluation of the SELF-7 intervention assessed using the purpose-developed terapist version of SELF-7 Treatment Feedback Scale (STFS). The terapist version of STFS is a 4-item therapist-rated measure assessing therapeutic alliance and collaboration, relevance of therapy content, appropriateness of the therapeutic approach, and the overall contribution of SELF-7 to the patient's understanding and management of self-disorders. Items are rated on an 11-point scale ranging from 0 ("not at all") to 10 ("to a very high degree"). Mean scores range from 0 to 10, with higher scores indicating more positive evaluations and greater acceptability of the intervention. Feasibility will be considered acceptable if at least 70% of therapists provide overall positive feedback.

  At end of therapy (week 16)

• Adverse Effects

  Therapy-related adverse effects will be assessed at end of therapy using the Negative Effects Questionnaire (NEQ-20), a 20-item self-report measure designed to assess unwanted and adverse effects associated with psychological treatment. The NEQ-20 will be used to evaluate the safety and tolerability of the SELF-7 intervention, alongside monitoring of serious therapy-related adverse events. Items are rated on a 5-point scale, and mean scores range from 0 to 4, with higher scores indicating more frequent and/or severe negative effects of treatment. A mean score of 0 indicates no reported negative effects, whereas a mean score of 4 indicates the highest level of reported negative effects. The adverse effects criterion is met if no more than one serious therapy-related adverse event (as defined in the protocol) occurs during the intervention period (week 0 - week 16) and if fewer than 10% of participants have a mean NEQ-20 score greater than 2 measured at end of therapy (week 16).

  From inclusion (week 0) until end of therapy (week 16)

Secondary Outcomes (11)

• Psychological Outcome Profiles (PSYCHLOPS)

  T0 (baseline pre-allocation), T1 (16 weeks post-allocation), and T2 (26 weeks post-allocation)

• Readiness for Psychotherapy (RPI)

  Baseline (pre-allocation)

• Personal Recovery (Brief INSPIRE-O)

  Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)

• The WHO Well-Being Index (WHO-5)

  Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)

• The Perceived Stress Scale (PSS-10)

  Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)

Study Arms (2)

SELF-7 Intervention + F-ACT

EXPERIMENTAL

SELF-7 psychotherapeutic intervention as add-on to standard outpatient Flexible Assertive Community Treatment (F-ACT)

Other: SELF-7; Other: F-ACT

F-ACT alone

ACTIVE COMPARATOR

Standard outpatient Flexible Assertive Community Treatment (F-ACT) alone

Other: F-ACT

Interventions

SELF-7 OTHER

SELF-7 is a manualized, phenomenologically informed psychotherapeutic intervention with integrated psychoeducational components targeting self-disorders in schizophrenia spectrum disorders. The intervention is delivered according to a manual comprising seven therapeutic modules and constitutes a therapeutic framework that supports patients' awareness, understanding, and coping with difficulties related to self-disorders. While manualized, the therapeutic process is flexible and may move back and forth between modules to meet individual patient needs. SELF-7 aims to support coherence in self-experience, strengthen adaptive coping, and facilitate change. The intervention consists of 12 individual psychotherapy sessions preceded by an Examination of Anomalous Self-Experience (EASE) interview and is delivered as an add-on to standard Flexible Assertive Community Treatment (F-ACT).

SELF-7 Intervention + F-ACT

F-ACT OTHER

Flexible Assertive Community Treatment (F-ACT) is the standard outpatient treatment provided in the participating mental health services. F-ACT includes medical consultations, regular contact with a designated case manager, and network and coordination meetings. The model is flexible, allowing the intensity of care, including consultations and home visits, to be increased according to clinical need. Participants continue receiving F-ACT throughout the study period.

F-ACT alone; SELF-7 Intervention + F-ACT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years.
• Capacity to understand study procedures and provide written informed consent.
• ICD-10 diagnosis of schizophrenia (F20.x) or schizotypal disorder (F21).
• Receiving treatment in a Flexible Assertive Community Treatment (F-ACT) team.
• Discharged from the OPUS early intervention outpatient programme within the past 5 years.

You may not qualify if:

• Insufficient proficiency in Danish to participate in psychotherapy and complete study assessments.
• Current severe alcohol or substance dependence.
• Current forensic psychiatric status.
• Clinically assessed elevated risk of severe self-harm, suicide, or harm to others.
• Severe comorbid somatic illness or severe comorbid psychiatric disorder that substantially compromises the ability to participate in psychotherapy.
• Not deemed able to participate in psychotherapy based on clinical judgment.

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead

Study Sites (1)

Psychiatric Research Unit, Mental Health Services Region Zealand

Slagelse, Region Sjælland, 4200, Denmark

Location

Central Study Contacts

Toke Lenskjold

CONTACT

+45 - 31667874; toul@regionsjaelland.dk

Sidse Marie Arnfred

CONTACT

+45 - 24227045; sidar@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and therapists cannot be blinded to treatment allocation. Outcome assessments involving clinician-rated measures at baseline (T0) and follow-up (T2), including the Examination of Anomalous Self-Experience (EASE), Scale for the Assessment of Positive Symptoms (SAPS), Brief Negative Symptom Scale (BNSS), Personal and Social Performance Scale (PSP), and the Positive and Negative Syndrome Scale (PANSS) Item G12, are conducted by the PhD investigator, who remains blinded to treatment allocation throughout the trial. Self-report questionnaires and feasibility assessments collected at end of therapy (T1) are administered by research therapists and are therefore not blinded. Statistical analyses are performed by an independent statistician with treatment allocation concealed during the primary analyses, and conclusions are prepared before unmasking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Research

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 25, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)