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

NCT ID: NCT06790186

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2031-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

We plan for the assessor to be blinded when scoring the PRPP assessment. Therefore, one occupational therapist will conduct the assessments before and after the intervention, and another will provide the intervention for the participants. Additionally, to monitor observer drift , a third occupational therapist (the PhD candidate and the main supervisor) will be blinded to the phases and score 20 % of the PRPP assessments.

Study Groups

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Perceive, Recall, Plan and Perform intervention

Perceive, Recall, Plan and Perform (PRPP) intervention in promoting effective use of cognitive strategies for adults with schizophrenia in performing their daily activities will be given to all the included patients.

Group Type OTHER

Perceive, Recall, Plan and Perform intervention Interventions:

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Haug, PhD

Role: STUDY_CHAIR

Sykehuset Innlandet HF

Central Contacts

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Elisabeth Haug, PhD

Role: CONTACT

0047 95781487

Pia Marie Reinfjord Johnsen, PhD candidate

Role: CONTACT

0047 95761673

References

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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.

Reference Type BACKGROUND
PMID: 36811612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29253607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19487353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20854512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36198473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34716157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32052837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33877289 (View on PubMed)

Other Identifiers

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798582

Identifier Type: -

Identifier Source: org_study_id

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