Psychotherapy for Abnormalities of Self-VITALITY in Patients With Schizophrenia Spectrum Disorder: A Feasibility RCT [VITALIZE]
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Therapist Evaluation
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Clinically stable with regard to antipsychotic treatment (receiving antipsychotic medication or not receiving antipsychotic medication) and with no planned substantial changes in antipsychotic treatment at the time of inclusion.
排除标准
- •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.
研究组 & 干预措施
SELF-7 Intervention + F-ACT
SELF-7 psychotherapeutic intervention as add-on to standard outpatient Flexible Assertive Community Treatment (F-ACT)
干预措施: SELF-7 (Other)
SELF-7 Intervention + F-ACT
SELF-7 psychotherapeutic intervention as add-on to standard outpatient Flexible Assertive Community Treatment (F-ACT)
干预措施: F-ACT (Other)
F-ACT alone
Standard outpatient Flexible Assertive Community Treatment (F-ACT) alone
干预措施: F-ACT (Other)
结局指标
主要结局
Therapist Evaluation
时间窗: At end of therapy (week 16)
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.
Acceptability
时间窗: From eligibility assessment to randomization
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.
Adherence
时间窗: From inclusion (week 0) to end-of-therapy (week 16)
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.
Patient Satisfaction
时间窗: At end of therapy (week 16)
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.
Participant Evaluation
时间窗: End of therapy (week 16)
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.
Adverse Effects
时间窗: From inclusion (week 0) until end of therapy (week 16)
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).
次要结局
- 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))
- The Suicidal Ideation Attributes Scale (SIDAS)(Baseline (pre-allocation), end of therapy (week 16), and follow-up (week 26))
- The Personal and Social Performance Scale (PSP)(Baseline (pre-allocation) and follow-up (week 26))
- The Scale for the Assessment of Positive Symptoms (SAPS)(Baseline (pre-allocation) and follow-up (week 26))
- The Brief Negative Symptom Scale (BNSS)(Baseline (pre-allocation) and follow-up (week 26))
- The Positive and Negative Syndrome Scale (PANSS) Item G12(Baseline (pre-allocation) and follow-up (week 26))
- The Examination of Anomalous Self-Experience (EASE)(Baseline (pre-allocation) and follow-up (week 26))
研究者
Sidse Arnfred
Clinical Professor, Head of Research
Psychiatric Research Unit, Region Zealand, Denmark