Routine Outcome Monitoring and Feedback Informed Therapy in Italy: 1st Italian RCT Large Population Study (PRIN - Italian Minister of Universities and Research Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Clinical Outcomes in Routine Evaluation-10 (Change in Session by session)
研究概览
简要总结
The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy.
The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan.
Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:
I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.
Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/).
Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables.
详细描述
- Backgrounds:
Routine outcome monitoring (ROM), including feedback, has its roots in the practice-based evidence paradigm, particularly patient-centered research. The administration of outcome measures, either continuously or at regular intervals as a means of checking progress and informing treatment decision making, can produce an ameliorative effect in addition to the effects produced by standard psychological therapies. ROM has been referred to by various terms, but they all contain features that can be grouped into three sequential steps: (i) collecting patient data in a regular and structured manner; (ii) providing the data to the therapist and, on many occasions, to the patient as well; and (iii) when appropriate, adjusting the process or focus of therapy in light of the feedback that emerged. These three steps have been presented as a transtheoretical model of measurement-based care- Collect, Share, Act -while a definition of ROM that captures these three steps describes it as the implementation of standardized measures, usually session by session, to guide clinical decision making, monitor treatment progress, and indicate when functional modification of treatment is needed. ROM has been presented as a relatively simple evidence-based practice that the clinician can add to any type of psychotherapy without requiring changes in that psychotherapy. The use of ROM and feedback in routine care has long been recommended. A recent advisory committee advocated for professional practice guidelines that focus on measurement-based care and feedback. These guidelines include a statement that therapists should engage in regular evaluation of the treatment process and outcomes, incorporating this information into ongoing collaboration with patients. International scientific organizations are called to increasingly use Feedback Informed Therapy (FIT) and the use of ROM, to assess outcomes, inform goals, objectives,and to monitor individual progress and guide decisions about individual care, treatment or service plans. The use of ROM is also supported by the Roadmap for Mental Health Research in Europe. In addition, national policymakers and regulatory bodies in some countries have made measurement of treatment outcomes mandatory.
ROM has been widely adopted in various therapeutic modalities for adults, for example, in psychodynamic therapy, couples therapy, and group therapy, as well as for specific problems such as substance abuse and in youth settings. It is a pan-theoretical approach and, as a therapeutic method, combines elements of supervision, ongoing assessment, and overall quality assurance.
In addition to considerations of the effects and benefits of ROM, there is also a relevant component of substantial change in the practice of professional activity in the project due to the introduction of digital technology. While there is consensus in the scientific community that digital can be of benefit to professionals, similarly, evidence indicates that such benefits occur under various conditions, including the effective integration of these technologies into daily practice. In this scenario, the possession and development of appropriate skills in the use of digital tools assumes a central role.
Equally central to the implementation of digitally supported ROM is the usability of digital technology, which will be tested through special experience and usability questionnaires on both the patient and therapist sides. Usability will also be assessed through targeted interviews with a subsample of psychotherapists, following the track of validated technology usability questionnaires and analyzed through thematic analysis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Terapists with a regular specialisation diploma in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), in activity; and/or specialising in psychotherapy at least in their third year will be selected.
- •There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue).
- •Patients: Approximately 1500 to 2000 patients will be recruited, 5 new patients per therapist.
- •New patients seen for less than 3 sessions.
- •Adult patients, 18 years of age or older.
排除标准
- •Patients: - No restrictions on diagnoses except for the following: Psychosis and neurocognitive disorders, because as pointed out by Barkham and colleagues when using ROM and FIT the clinical population and context must be considered.
结局指标
主要结局
Clinical Outcomes in Routine Evaluation-10 (Change in Session by session)
时间窗: Session by session (every weeks from baseline to up to 6 months)
Patients whose therapists were in the OPM-F condition will have better results in terms of decreasing distress (CORE-10) from session to session than patients of therapists in the OPM condition and the TAU condition. Patients whose therapists were in the OPM condition will have better results in terms of decreasing discomfort (CORE-10) from session to session than patients of therapists in the TAU condition. CORE-10 is a short 10-item measure to explore psychological distress developed for outcome monitoring in clinical settings Items are rated on a 5-point Likert-type scale (from 0 = not at all to 4 = most or all of the time), and higher total scores (i.e., the sum of all items, ranging from 0 to 40) indicate greater distress.
Working Alliance Inventory-Short Revised-Client (Change in session by session)
时间窗: Session by session (From baseline to up to 6 months)
Patients of therapists in the OPM-F condition will report a greater increase in therapeutic alliance during therapy sessions than patients in the OPM and TAU conditions. Patients of therapists in the OPM condition will report a greater increase in therapeutic alliance during therapy sessions than patients in the TAU conditions.
Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months)
时间窗: Baseline, T2 (up to 6 months), Follow-up (3 months)
Patients whose therapists were in the OPM-F condition will have better results in terms of reduction of symptom severity (GAD7-PHQ9) at the end of treatment (after 15 sessions/up to 6 months) and three months after treatment (follow up) than patients of therapists in the OPM condition and TAU condition. GAD is a 7-item self-report screening instrument for the assessment of generalized anxiety disorder (GAD). Each item is rated on a 4-point Likert scale (0 = "Not at all" to 3 = "Almost every day"), with higher scores reflecting greater severity of GAD. Patient Health Questionnaire is a 9-item self-report instrument that assesses symptoms of depression. Each item is rated on a 4-point Likert scale (0 = "Not at all" to 3 = "Almost every day"), with higher scores indicating greater severity of depression.
次要结局
- Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes(T2 (up to 6 months) and follow-up (3 months))
- Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7(Baseline, T2 (up to 6 months), follow up (3 months))
研究者
Angelo Compare
Prof. Angelo Compare
University of Bergamo