Clinical trial NCT06790186: Improving Real-world Function for Persons with Schizophrenia: a Single-case Experimental Design
Official title: Improving Real-world Function for Persons with Schizophrenia (ImproFunc): a Single-case Experimental Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: Cognitive difficulties
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2025-01-23
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Perceive, Recall, Plan and Perform (PRPP) intervention, to promote effective use of cognitive strategies for adults with schizophrenia when performing everyday activities in a real-world context. 27 persons with cognitive impairment due to schizophrenia will be included and provided the PRPP intervention in eight sessions. A single case experimental design with multiple baselines will be used to investigate the effectiveness of the PRPP intervention.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: PRPP assessment
timeFrame: Assesments just after the intervention, as well as at 3 and 6 months
Secondary outcomes:
measure: Goal Attainment Scale
timeFrame: Assesments just after the intervention, as well as at 3 and 6 months
measure: Health of the Nation Outcome Scale
timeFrame: Assesments just after the intervention, as well as at 3 and 6 months
measure: Social Functioning Scale
timeFrame: Assesments just after the intervention, as well as at 3 and 6 months
measure: Questionnaire about the Process of Recovery
timeFrame: Assesments just after the intervention, as well as at 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Sykehuset Innlandet HF
name: Elisabeth Haug, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.