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

NCT06790186 | Not Yet Recruiting

• 1 other identifier: 798582
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Cognitive difficulties

Outcome Measures

Primary Outcomes (1)

• PRPP assessment

  Effective use of cognitive strategies in performing their daily activities

  Assesments just after the intervention, as well as at 3 and 6 months

Secondary Outcomes (4)

• Goal Attainment Scale

  Assesments just after the intervention, as well as at 3 and 6 months

• Health of the Nation Outcome Scale

  Assesments just after the intervention, as well as at 3 and 6 months

• Social Functioning Scale

  Assesments just after the intervention, as well as at 3 and 6 months

• Questionnaire about the Process of Recovery

  Assesments just after the intervention, as well as at 3 and 6 months

Study Arms (1)

Perceive, Recall, Plan and Perform intervention

OTHER

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.

Behavioral: Perceive, Recall, Plan and Perform intervention Interventions:

Interventions

Perceive, Recall, Plan and Perform intervention Interventions: 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

Perceive, Recall, Plan and Perform intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Norwegian University of Science and Technology: collaborator

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Elisabeth Haug, PhD

  Sykehuset Innlandet HF

  STUDY CHAIR

Central Study Contacts

Elisabeth Haug, PhD

CONTACT

0047 95781487; elisabeth.haug@sykehuset-innlandet.no

Pia Marie Reinfjord Johnsen, PhD candidate

CONTACT

0047 95761673; pia.Johnsen@sykehuset-innlandet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2031
• Last Updated: January 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share