Psychotherapy for Self-Disorders in Schizophrenia Spectrum Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPsychiatric Research Unit, Region Zealand, Denmark
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SELF-7
Other interventionSELF-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).
F-ACT
Other interventionFlexible 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: SELF-7 Intervention + F-ACTExperimental treatment 2 interventions
Group B: F-ACT aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From eligibility assessment to randomization2
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.
Time frame
From inclusion (week 0) to end-of-therapy (week 16)3
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.
Time frame
At end of therapy (week 16)4
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.
Time frame
End of therapy (week 16)Secondary outcomes
1
Psychological Outcome Profiles (PSYCHLOPS)
Psychological Outcome Profiles (PSYCHLOPS), an individualized idiographic patient-reported outcome measure (I-PROM) that measures psychological distress, and will serve as the primary exploratory outcome. PSYCHLOPS includes four items covering three domains: (1) Problems; (2) Function; and (3) Well-being. A six-point rating scale is used to score the intensity and duration of psychological distress. PSYCHLOPS is adapted to assess psychological distress related to self-disorders, as participants follow a structured procedure that guides them in identifying and rating their main self-defined psychological problems and associated distress related to self-disorder phenomena. Higher scores indicate greater psychological distress related to self-disorders.
Time frame
T0 (baseline pre-allocation), T1 (16 weeks post-allocation), and T2 (26 weeks post-allocation)2
Readiness for Psychotherapy (RPI)
The RPI is a self-report measure to assess seven dimensions of readiness for psychotherapy: level of distress, desire for change, willingness to work in therapy, recognition of problems as psychological, willingness to discuss personal matters, willingness to endure discomfort in therapy, and responsibility for change. 42 items; 5-point Likert scale. 7 subscales; total score and subscale scores are analyzed; higher scores indicate greater readiness.
Time frame
Baseline (pre-allocation)3
Personal Recovery (Brief INSPIRE-O)
The Brief INSPIRE-O is a patient-reported outcome measure assessing personal recovery across the domains of connectedness, hope, identity, meaning, and empowerment (CHIME). The instrument consists of 10 items covering five domains, rated on a 5-point Likert scale. Total scores range from 10 to 50. Higher scores indicate greater perceived personal recovery.
Time frame
Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)4
The WHO Well-Being Index (WHO-5)
The WHO Well-Being Index (WHO-5) is a self-report measure of current subjective psychological well-being. The instrument consists of 5 items rated on a 6-point Likert scale. Raw scores range from 0 to 25 and are transformed to a scale ranging from 0 to 100. Higher scores indicate better well-being.
Time frame
Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26)Sponsors and contacts
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Source ClinicalTrials.gov
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