Improving Real-world Function for Persons with Schizophrenia: a Single-case Experimental Design

Официальное название

Improving Real-world Function for Persons with Schizophrenia (ImproFunc): a Single-case Experimental Design

Обзор

Existing treatment for individuals with psychosis primarily targets positive symptoms but has only modest effects on cognition and negative symptoms. Cognitive strategy training shows promising effects in reducing negative symptoms and increasing activity initiation in individuals with schizophrenia. This project aims to investigate the effect of the Perceive, Recall, Plan and Perform (PRPP) intervention in promoting effective use of cognitive strategies for adults with schizophrenia in performing their daily activities. Twenty-seven individuals with schizophrenia will be recruited from Sykehuset Innlandet (Innlandet Hospital Trust) and assessed using PRPP prior to an eight-session PRPP intervention. Re-assessment will be conducted after the intervention, as well as at 3 and 6 months, to evaluate the long-term effects of the intervention. A single-case design will be used to investigate the intervention's effects. The primary outcome measure will be the PRPP assessment, and the secondary outcome measure will be the Goal Attainment Scale (GAS). Generalization measures will be used to evaluate whether there are relevant changes beyond the primary and secondary goals.

Вмешательства

• Поведенческое Perceive, Recall, Plan and Perform intervention Interventions:
  The PRPP is a standardized system which determines the impact of information processing on performance of everyday activities. It is a method for assessment of performance mastery, and efficient use of cognitive strategies, as well as a model of intervention to train mastery and cognitive strategy use, in everyday activities. The PRPP assess task performance mastery, as well as cognitive strategy application

Первичные конечные точки

• PRPP assessment [Срок оценки: Assesments just after the intervention, as well as at 3 and 6 months]

Вторичные конечные точки (4)

• Goal Attainment Scale [Срок оценки: Assesments just after the intervention, as well as at 3 and 6 months]
• Health of the Nation Outcome Scale [Срок оценки: Assesments just after the intervention, as well as at 3 and 6 months]
• Social Functioning Scale [Срок оценки: Assesments just after the intervention, as well as at 3 and 6 months]
• Questionnaire about the Process of Recovery [Срок оценки: Assesments just after the intervention, as well as at 3 and 6 months]

Критерии участия

Критерии включения

• DSM-5 diagnosis of schizophrenia, understand and speak Norwegian, live in their own community context, but are patients in Sykehuset Innlandet ( Innlandet Hospital Trust), either as outpatients or on discharge from inpatient care, a subjective experience of functional impairment and/or cognitive difficulties identified in an initial interview, and a stable state without any major medication change for at least two months before inclusion

Критерии исключения

• Major physical disability, a current substance abuse problem, and cognitive deficits of organic origin or mental retardation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Aydin O. Rise of single-case experimental designs: A historical overview of the necessity of single-case methodology. Neuropsychol Rehabil. 2024 Apr;34(3):301-334. doi: 10.1080/09602011.2023.2181191. Epub 2023 Feb 22. PMID 36811612
• Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15. PMID 29253607
• Aubin G, Stip E, Gelinas I, Rainville C, Chapparo C. Daily functioning and information-processing skills among persons with schizophrenia. Psychiatr Serv. 2009 Jun;60(6):817-22. doi: 10.1176/ps.2009.60.6.817. PMID 19487353
• Aubin G, Chapparo C, Gelinas I, Stip E, Rainville C. Use of the Perceive, Recall, Plan and Perform System of Task Analysis for persons with schizophrenia: a preliminary study. Aust Occup Ther J. 2009 Jun;56(3):189-99. doi: 10.1111/j.1440-1630.2007.00725.x. PMID 20854512
• Lindstad MO, Obstfelder AU, Sveen U, Stigen L. Effectiveness of the Perceive, Recall, Plan and Perform intervention for persons with brain injury in community-based rehabilitation: protocol for a single-case experimental design with multiple baselines. BMJ Open. 2022 Oct 5;12(10):e060206. doi: 10.1136/bmjopen-2021-060206. PMID 36198473
• Rocamora-Montenegro M, Compan-Gabucio LM, Garcia de la Hera M. Occupational therapy interventions for adults with severe mental illness: a scoping review. BMJ Open. 2021 Oct 29;11(10):e047467. doi: 10.1136/bmjopen-2020-047467. PMID 34716157
• Allott K, van-der-El K, Bryce S, Parrish EM, McGurk SR, Hetrick S, Bowie CR, Kidd S, Hamilton M, Killackey E, Velligan D. Compensatory Interventions for Cognitive Impairments in Psychosis: A Systematic Review and Meta-Analysis. Schizophr Bull. 2020 Jul 8;46(4):869-883. doi: 10.1093/schbul/sbz134. PMID 32052837
• Vita A, Barlati S, Ceraso A, Nibbio G, Ariu C, Deste G, Wykes T. Effectiveness, Core Elements, and Moderators of Response of Cognitive Remediation for Schizophrenia: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Psychiatry. 2021 Aug 1;78(8):848-858. doi: 10.1001/jamapsychiatry.2021.0620. PMID 33877289

Идентификаторы

NCT: NCT06790186 · 798582

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗